Individual Enquiry Research Paper 2012 Title: Oncologists and cancer specialists’ expert opinion on the role of osteopathic treatment on patients with cancer Author: Dawn Hammond BSc (Hons) Supervisor: Mr Chris Thomas MA (Med Ed) BSc (Hons) Ost, PGCAP, FHEA The British School of Osteopathy 275, Borough High Street, London, SE1 1JE Abstract Background: 1 in 3 people in the UK are affected by cancer according to Sasieni et al (2010). Despite this Walters et al (2011) report improving cancer survivorship. Mallik & Leonard, (2009) predict increasing numbers of these patients presenting to manual therapists with musculoskeletal problems. Hann et al (2004) suggest little is known about cancer specialists’ views on manual therapy. Objectives: Explore cancer specialist’s opinions on the risks and benefits of osteopathy on patients with cancer. Explore their experiences of patients having manual therapy. Investigate their rationale for referral. Methods: 12 semi-structured qualitative interviews were conducted with cancer specialists’. The interviews were analysed using elements of grounded theory. Intrarelater reliability found 98% agreed. Inter-rater reliability found 89% was agreed after discussion of errors and omissions. Results: Benefits were associated with osteopathic treatment on patients with cancer. Oncologists did not believe osteopathy increased metastatic spread risk but were concerned about increased fracture risk. Few oncology consultants informally recommended osteopathic treatment. Conclusion: Participants agreed there could be a role for osteopathy in the care of patients with cancer. Education, collaboration and research are required to facilitate inclusion into oncology healthcare. Key Search Words: Osteopathy, Chiropractic, Physiotherapy, Manipulation, Massage, Manual therapy, Cancer, Oncologists Page 1 of 61 Introduction Rationale Sasieni et al (2011) state, that 1 in 3 people are affected by cancer in the United Kingdom (UK) and according to Cancer Research UK (CR UK) (2011) the most common cancers diagnosed in the UK, in order of prevalence are: Breast, Prostate, Lung, Bowel, Malignant Melanoma, Lymphoma, Bladder and Kidney Cancer. Walters et al (2011) report UK cancer survival rates improved in 21 common cancers. Mallik & Leonard, (2009) propose long survivorship of patients with cancer, means an increased chance of developing other chronic conditions which may initiate use of complementary and alternate medicine (CAM). Increasing cancer prevalence and improving survival rates suggest osteopaths might be more likely to come into contact with people who have a history of cancer. It is therefore beneficial to gain opinions of cancer specialists’ with expertise in the most commonly diagnosed cancers into treatment of this patient population. Existing research on Oncologists opinions Hyodo et al (2003) and Samano et al (2005) conducted questionnaire studies on oncologists’ opinions of CAM of 751 and 119 participants respectively. They found the majority had a lack of knowledge of CAM citing a lack of supportive scientific evidence but despite this 92% and 68.8% respectively accepted the use of CAM on patients with cancer. Hyodo et al (2003) and Hann et al (2004) found a large proportion of oncologists support the use of massage on patients with cancer. Hann et al (2004) found physicians commonly believed patients pursued CAM to take control of their treatment. Samano et al (2005) identified a significant positive correlation between oncologists with personal experience of CAM and their Page 2 of 61 recommendation of CAM to patients. Hann et al (2004), Habermann et al (2009) and Cox (2010) recommended research into cancer specialists’ opinions specifically on manual treatment on patients with cancer, where as existing research investigated opinions on CAM in general. Existing referral recommendations The G.Os.C (2006) and Schneider & Gilford (2008), report most patients self refer. The G.Os.C (2006) found that only 1/5th of all patients presenting to an osteopath were referred by a doctor, however Schneider & Gilford (2008) provided no evidence to support this statement. The Department of Health musculoskeletal services framework (2006) recommend development of multidisciplinary teams to reduce waiting times and better care for common musculoskeletal complaints. CR UK (2009) advocates the use of osteopathic treatment, The National Institute for Health and Clinical Excellence (NICE) (2009) suggest manual and manipulation treatment for non specific low back pain, whilst The National Cancer Action Team (NCAT) (2009) recommend physiotherapy for patients with cancer, guidelines include; teach exercise, set purposeful activity, postural re-education, massage/mobilise soft tissue, use of a TENS machine, use of heat and cold to ease pain and help with positioning. Cancernet UK (2011) state osteopaths use similar treatment modalities to physiotherapists with additional training in manipulative therapy. Bengough (2010) proposed barriers to osteopathic treatment of life limiting illnesses to be lack of knowledge, guidelines and the need to improve communication. Page 3 of 61 The Department of Health (2006), CR UK (2009), NCAT (2009) and NICE (2009) recommendations all imply a potential role for osteopathy. Concerns about Metastasis Cox (2010) found osteopaths were concerned that improving fluid health in a patient with cancer might accelerate the disease. Lerner (1994) and The International Society of Lymphology (2003), theorise that massage increases blood flow and mechanical compression could promote metastasis by tumour cell mobilisation. Godette et al (2006) argued metastasis of cancer is a biologic process, not the cell’s capacity to disseminate but ability to grow in a new location facilitated by the microenvironment. Godette et al (2006) argue manual lymphatic drainage does not contribute to the spread of cancer and should not be withheld from patients with metastasis however evidence was not provided to support these claims. Wu et al (2010), investigated 70 patients with osteosarcoma that had manipulative therapy with massage to the site of an osteosarcoma tumour prior to diagnosis of cancer, and found a significantly poorer five year survival rate and significantly greater incidence of lung cancer metastasis compared to 68 with no manipulative therapy. Wu et al (2010) theorise this may serve as a mechanism to spread tumour cells recommending manipulative treatment should be avoided in osteosarcoma. Shah & Salzman, (2011) conducted a review of imaging techniques and appearance of spinal metastases, reporting spinal metastasis occur in 60-70% of systemic cancer patients but only 10% were symptomatic. They believe the mechanism to be haemodynamic with the venous route of Batson's plexus thought Page 4 of 61 more important than the arterial route, rarely via the lymphatic system or direct invasion. Risks of reduced bone mineral density Howe (1993), Davis & Taylor, (2007), Roudier (2008) and Shah & Salzman, (2011) believe bone metastases result in bone mineral density reduction. Ernst (2007) identified three patients with pathological fractures following manipulative therapy when a diagnosis of cancer had been missed in a systematic review of manipulative therapy between 2001 and 2006. However, Breen (2006) found his exclusion criteria neglected studies which tested the effectiveness of manipulation. Roudier (2008) found bone metastases from prostate cancer appearing with increased bone density on x-ray, were under mineralised resulting in increased bone fragility. The small sample of 12 cannot be generalised to all prostatic metastases. CR UK (2009) caution against the strong manipulative techniques on patients with: osteoporosis, bleeding disorders, broken bones, cancer of the bone, spinal cord or marrow, during radiotherapy treatment and anticoagulant or steroid use. Benefits of manual therapy on patients with cancer According to the World Health Organisation (2010) osteopaths undergo extensive training over a minimum of four year’s full time, which overlaps medical training covering: anatomy, physiology, pathology, clinical methods and identification of pathology where treatment is not appropriate and referral for further investigation is required. Page 5 of 61 Osteopathy Guide (2010) proposes the benefits are: assist pain management, reduce tension, help mental outlook and relieve debilitating side effects from chemotherapy and radiotherapy. However, there was limited research identified on the effects of osteopathy on patients with cancer therefore this study explores the effects of the manual therapies of: massage, chiropractic and osteopathic treatment on patients with cancer. Effects on pain, mood and quality of life Kutner, et al (2008) performed a multisite study of 380 participants with advanced cancer examining massage effects on pain and mood compared to simple touch demonstrating the benefit of massage over touch. This was well documented and reproducible, performance bias was possible. Jane et al (2009) found massage significantly reduced pain and fatigue in 30 patients with bone metastasis for up to 18 hours. The method was well documented although weakened by variations in analgesia and small sample and therefore difficult to extrapolate to the population with bone metastases. Performance bias was possible. Kutner et al (2008) and Jane et al (2009) reported improvement in pain levels and mood in patients with cancer treated with manual therapy. Effects on function Schneider & Gilford (2008) and Hojan, et al (2011) report improved range of movement in individual case studies. In a case of chiropractic treatment of a terminally ill cancer patient with low back pain Schneider & Gilford (2008) reports reduction of medication and improved quality of life. In a case of abdominal cancer Page 6 of 61 Hojan et al (2011) describes physiotherapy and osteopathic techniques improving pain and fatigue. Individual case studies cannot be generalised to the population of patients with cancer but demonstrate treatment approach and effect. Clemens et al (2010) found 94% of 90 patients had symptomatic relief with lymphatic drainage reporting improvement. Variations in analgesia, small sample and lack of control group weaken this study. Treatment was discontinued in four, as manual therapy exacerbated their neuropathic pain which the authors dismissed as oversensitivity to touch rather than an adverse response to treatment. Stringer (2008) found one 20 minute light massage on 39 haematological participants undergoing intensive chemotherapy, significantly reduced cortisol levels temporarily and improved well-being. She suggests a potential effect on the immune system, if reduction of high levels of cortisol were sustained. The sample was small but the procedure was well explained and reproducible. Noll et al (2010) conducted a multicentre study on 406 participants reporting a statistical significant improvement with osteopathic treatment on patients with pneumonia resulting in reduced antibiotic duration, reduced hospital stay and reduced respiratory failure suggesting an influence on immune function. Noll et al (2010) did not investigate participants with cancer. Study relevance The aim of the study was to find out if oncologists refer patients with cancer to osteopaths and what they refer patients for. Investigate oncologists’ views on the risks and benefits of osteopathic treatment on patients with cancer and explore a potential role of osteopathy in the treatment of musculoskeletal symptoms in patients with cancer. Page 7 of 61 Method Design Qualitative semi-structured interviews were used to obtain cancer specialists opinions, views and experiences. Dawson (2009) recommends semi-structured interviews to compare and contrast interview content, explore detailed participant experiences and provide time and opportunity to discuss opinions and views. Recruitment 160 oncologists were invited within 50 miles of the British School of Osteopathy (BSO) taking every third name from the Dr Foster database and members of the National Cancer Research Institute. Recruitment and interviews took place between October and November 2011. Response rate was 8.75%. Participation A purposive sample of 12 currently practicing cancer professionals participated in the study: nine Oncology consultants, two specialist cancer nurses and one palliative care registrar. Sample size was determined by the BSO (2008) guideline for interview studies of four hours of recorded interview material or 8-12 participants. Participant criteria Inclusion: A preliminary questionnaire (see appendix 3) identified participants that either referred a patient or had personal experience of osteopathy, chiropractic or massage. Exclusion: One participant was excluded as they had no personal experience and had not referred a patient with cancer for manual therapy. Page 8 of 61 Materials sent to participants: Letter of invitation (see appendix 8), Participant information sheet (see appendix 1), Two consent forms (see appendix 2) Preliminary questionnaire (see appendix 3) Other materials: Researcher Interview Script (see appendix 7), Digital Voice Recorder. Weft QDA software (2006). MindApp Premium (2011). Procedure The participant information sheet, two consent forms, preliminary questionnaire, and invitation to participate were sent to participants. Participants were given two weeks following receipt of a signed consent form before arranging the interview to facilitate a period allowing participants to change their mind about participation. 11 face-to-face Interviews were conducted in mutually convenient quiet locations, two over the phone due to these participants current location. An introducing question advocated by (Kvale, 1996 pp.133) was used to “break the ice”. Open ended questions (see appendix 7) allowed participants to respond with “richness and spontaneity” as recommended by (Oppenheim 1992 pg 81). Interviews Page 9 of 61 were recorded using a digital voice recorder lasting between 5 and 32 minutes, four hours in total were transcribed by the author. Reliability Interview question content, validity and efficiency were discussed with the supervisor and reviewed by a professor of oncology. One pilot interview was conducted to trial the questions, identify bias, improve interviewer skills and check interview timing. This identified confusion about the therapies being discussed after discussing CAM therapies. Manual therapies were specified as osteopathy, chiropractic and massage and CAM questions were removed to prevent confusion. Intra-rater reliability was assessed as 98%. Assessed with inter-rater reliability 89% Data Analysis Interview transcriptions were offered to participants to review the content prior to inclusion in the study. No participants requested this option. Interview data was analysed with content analysis and elements of grounded theory. The interview transcripts read, reread and analysed for themes, meaning and associations. Software package Weft QDA version 1.0.1 (2006) was used to collate themes. Software package MindApp Premium version 7.0 (2011) was used to graphically display the data. Study ethics approval The BSO research committee gave approval on May 14th 2011. The NHS Ethics committee stated approval was not required providing the study commenced Page 10 of 61 after September 1st 2011 as participants were professionals. The NHS Research and Ethics Committee agreed with the NHS Ethics committee that approval was not required see appendix 4 & 5. Confidentiality & Anonymity The participant information form asked participants to avoid names or details that may lead to identification. Interviews were transcribed excluding names and identifiable details to protect identity. Participants were allocated a reference number so anonymous quotes by the participants could be used in the study. Name, contact details and digital recordings were securely stored by the author for the duration of the study then in a locked cabinet at the BSO on completion of the study for a period of six years after which they will be destroyed. Bias Selection bias is likely as participants chose to take part in the study. To minimise misunderstanding questions which might lead to bias, questions were checked with the research supervisor, a professor of oncology and piloted with an Oncology consultant. Open questions were used to minimise question leading question bias. There may be researcher bias as the author was studying to become an osteopath. To minimise reporting bias 16.7% of the interview data was transcribed and analysed by another final year osteopathy student then discussed and compared for inter-rater reliability. Page 11 of 61 Results Data analysis identified five themes: understanding of osteopathy, referral route, time constraints, manual therapy effects (see figure 2.0) Participants details Participant details Occupation Oncology consultant Oncology nurse Palliative care registrar Gender Males Females Age <30 31-40 41-50 51+ Participant numbers (gender) 9 (5 males, 4 females) 2 (1 male, 1 female) 1 (1 female) 6 6 1 9 1 1 Fig 1.0 Areas of specialisation In order of prevalence the areas of cancer specialism were: Haematology, Breast, Kidney, Various, Lung, Prostate, Bowel, and Lymphoma. Page 12 of 61 Uncertain of osteopathic training level No manual therapy training Areas of the body Joint manipulation Treatment perception Training Colleagues’ views Evidence based research Understanding of osteopathy Personal experience Concern about cost & availability First/Second-hand experiences No cost to patient Ease of access & communication Existing hospital facilities Barriers to osteopathy Convenience Referral No formal guideline Perception of the effect on the body Lack of supportive evidence base Protocol Confidence Personal Experience Short appointment times Patient experience Oncology appointments Recommendation for manual therapy Risk of fracture Time constraints Limited time: Prioritisation of training needs Oncology further training time demands NHS waiting lists for physio and pain clinics Long wait Risk of metastases Reduction of pain Feeling of control Negative effects Positive effects Risk of discomfort Manual therapy effects & role Risk of infection spread Improvement of mood Fig 2.0 Interview data themes and sub themes Page 13 of 61 Improvement in function, mobility and movement Theme one: Understanding and perception of osteopathy This theme was divided into sub themes of training, treatment perception, colleagues’ views and evidence base. Training No oncology consultants had training on any manual therapies. One nurse and one palliative care registrar had undertaken post graduate training explaining risks and benefits associated with manual therapy. Eight participants (66.7%) described their knowledge of osteopathy originating from personal or patient experience with two participants (16.7%) claiming no knowledge at all. I don't think there is enough knowledge about chiropractors and osteopaths. I think that is something could be, we could all be more educated about that with more education and more links between the two professions we would be able to refer patients on.” (9) Uncertainty was identified on the level of training of the osteopathic profession and if identification of serious pathology was covered. One oncologist expressed surprise at the length of time required to qualify as an osteopath. “You know, I think I would hope that in manual therapists training they also train to be aware of what the red flags would be with regarding cancer.” (1) “I can remember at least two cases where the chiropractor or the osteopath told the patient this is not right just go and see a specialist and then do something about it. It just doesn't sound right which was very good, very perceptive.” (12) Osteopathic treatment perception Participants commonly described osteopathic treatment as: manipulation of the joints and the bones in the limbs and in the back. One participant described osteopathy as a holistic view of looking at patients. Page 14 of 61 “Alignment of musculoskeletal systems.” (1) “Osteopathy would be manipulation of the joints and the bones either in the limbs or the back.” (10) Participants described conditions helped by osteopathy as: mechanical, chronic or degenerative back pain, muscle soreness, mobility, balance problems and repetitive strain injuries. “Alleviates um, um, pain and other problems people have with their back and mobility” (2) “Mechanical back pain” (2). “Degenerative back problem.” (2) “It is a useful thing to do because they get more suppor.t” (2) “I think specifically the main benefit would be when a patient has muscle spasm associated with muscular pain. Muscle spasm associated with joint pain because of misalignment of joints as a result of muscle spasm. Which, could be caused by a problem with another joint causing asymmetry, causing an isolated muscle problem?” (9) “I suspect you see muscle soreness and chronic back ache.” (12) Confusion existed for participants on the difference between chiropractic and osteopathic treatment. “I get kind of confused between chiropractors and osteopathy.” (10) “I had an idea that it is similar to chiropractors but that’s it really.” (12) Page 15 of 61 Colleagues views on manual therapy Six participants (50%) did not know what colleagues thought about manual therapy on patients with cancer having not discussed this topic with colleagues. “Um, and depending on how intelligently they realise they don't understand um so will sort of say I don't know and some will say don't touch it with a barge pole.” (1) “I guess not so many necessarily talk about it so much apart from the sort of physio side.” (7) “that is difficult as I've never really asked them.” (10) Four participants (33.3%) felt colleagues thought manual therapy complementary to standard medical treatment on patients with cancer and encouraged it. Nurses and palliative care team colleagues were thought to have a positive outlook on manual therapy on patients with cancer. “I think physiotherapy and massage are viewed very positively by the palliative care profession.” (9) Two (16.7%) felt colleagues had a negative outlook suspecting some bias against osteopathic and chiropractic practice as they are thought to be poorly trained with a lack of supportive evidence. “Chiropractors and Osteopaths would have a little bit more knowledge to dispel the myths that we have about them and to practice more safely. So I think more education is necessary in the two areas.” (9) “I’m not sure if they are sceptical in a bad way, I just think they feel if there is not enough evidence they wouldn't feel comfortable strongly recommending complementary therapy.” (10) Page 16 of 61 Osteopathic evidence base Seven participants (58.3% or 77.8% of oncologists) felt there was the lack of evidence based research to support the use of osteopathy on patients with cancer. “Yes, evidence you need if you want to recommend things.” (2) “I don't know enough about it and my mindset has always been that is there evidence, are there trials, what's there experience of it.” (8) “You know, in, in, um in our cancer. Very evidence based you know on trials and things. Um, you know, I don't like commenting on anything unless I have actually read about it properly.” (10) Page 17 of 61 Theme two: Referral This theme was divided into sub themes of protocol, convenience, confidence, manual therapy referral, communication. “It's all a question of priorities. In oncology you have to look into what the real problem is for the patient what they are really suffering for and adjust your treatment accordingly.” (2) Protocol 11 participants (91.7%) felt there was no set protocol for referral for musculoskeletal symptoms. All participants described running appropriate tests or scans were run to check if symptoms were related to cancer. If unrelated to cancer then either prescription of analgesia and/or three participants (25%) described referring for physiotherapy (despite 10 (83.3%) having referred for physiotherapy at some point), two (16.7%) referred for massage (despite nine (75%) having recommended massage at some point), one (8.3%) referred to a cancer nurse specialist and one referred back to the GP. “The first thing you do is try to work out if it is related to their cancer or not. That's my job if you so like. So, you do scans, you know you take a history, you examine the patient with scans, um, and then you know, if the problem isn't related to cancer.” (2) “We only refer our patients when they are safe enough to receive manual therapy.” (5) “If they have things that seem to be joint aches and pains we can prescribe painkillers for that and again refer them for physiotherapy. If it seems to be a bony problem for example bony pain from metastatic disease we don't tend to refer them unless there is any associated muscle spasm.” (9) Page 18 of 61 Musculoskeletal symptoms reported to oncologists Related to cancer? X-ray, MRI, Blood tests Yes No Reassurance Medical treatment e.g. Chemotherapy, Radiotherapy, Analgesia, Bisphosphonates Analgesia Referral to either: Physiotherapy, GP, Nurse Specialist, Massage Fig 3.0 Referral decision process Convenience A common theme regarding referral pathway was the convenience of existing hospital services. Participants described existing hospital services as the more likely referral pathway and reasons given were: ease of access for patients, no cost to patients and the ease of communication with hospital services. “So unless they have the resources to get private physio we don't tend to refer.” “(9) Page 19 of 61 Nine (75%) described massage as readily available in the hospitals visited and widely accepted. Confidence A lack of confidence in manual therapies was demonstrated by two participants. A first-hand experience of two missed cervical spine fractures from road traffic accidents and a second-hand report of two vertebral artery dissections associated with manipulative treatment. None of the patients involved had cancer. “Um, vertebral artery dissections, so um, it’s just when I was doing neurology we had a few people that had some neck manipulation that went a bit wrong. So that’s the only real experience I’ve had.” (7) “I've heard about situations where medical issues like cervical spine fractures have been missed by chiropractors and osteopaths leading to delay in diagnosis after things like road traffic accidents probably on about 2 occasions.” (9) Manual therapy referral No cancer specialists referred patients for osteopathic treatment. Reasons given included a lack of understanding of the profession, a lack of evidence base, unsure of where available and concerns about patients’ financial situation. One felt all patients should have access to osteopathy on the NHS and it would be beneficial to patients with or without cancer. One described some cancer treatments as known to cause musculoskeletal symptoms and these were normally self limiting. Two (16.7% or 22.2% of oncology consultants) recommended patients consider osteopathy or chiropractic treatment. Page 20 of 61 “particularly for patients that don't have recurrence of cancer I do sometimes suggest, have you thought about chiropractic or osteopathy?” (1) “Well, um, I suggest to them that they consider it. I mention it if they have mechanical back pain without any particular significant reasons behind it then I suggest them to consider that.” (2). These two participants would not refer to one practitioner over another. Both had personal experience of osteopathy. “No, I would never make a formal referral I suppose as I don't want to be seen as recommending one particular practitioner over another.” (1) “I try not to promote one practitioner in particular or I just suggest to them to have consider it or what will work for them.” (2) Seven participants (58.3%) thought personal experience an important factor in their decision regarding referral/recommendation of manual therapy treatment to their patients. “I mean, yes for physical pain issues from my experience I've found chiropractic and osteopathy helpful.” (1) “Your personal experience helps you with your decision making process. Absolutely” (1) “I've had personal experience in terms of having the common term is slipped discs and having a course of osteopathy for that with acupuncture and it worked. I was absolutely amazed by it. So I have a lot of faith in it.” (5) Communication Nine participants (75%) felt patients discussed their musculoskeletal symptoms with them, Two (16.7%) felt only some patients did and One (8.3%) suspected not all patients mentioned their musculoskeletal symptoms. Six participants (50%) were aware their patients had self referred for a manual therapy. Page 21 of 61 Five participants (41.7%) would like to be contacted regarding manual therapy treatment on patients with cancer. One did not always see the same patients. One felt it important to be fully informed what treatment was being undertaken by patients, one felt it unnecessary. Preferred communication methods were: telephone call, bleep, NHS.net or meeting. Concern was expressed about the use of emails due to passing patient sensitive data using this unsecure method. Participants recommended getting to know the local oncology consultants' preferred level of contact and method. “I don't always see the same patients.” (1). “I am happy to be contacted about any aspect of my patients care but I don't think that it is mandatory for me to know what is going on as the patient will have made in most cases made that independent decision themselves to go to that practitioner.” (1) “The majority of healthcare professionals should be now on NHS.Net. So, should be contactable. Because there's also the thing about patient confidentiality and yeah, um, sending secure information over email, Secondly is calling, phoning. So, you know like, our team don't mind being phoned by anyone outside this particular organisation or being bleeped or paged.” (5) “Um, it’s normally phone calls or MDT's”. “a meeting once a week where the physios, the OT, the nurses and doctors sit down and discuss the progress of the patients.” (7) “I mean the best way would be that you just ring the secretary. The secretary is always there. And then leave a message and then we would chat to you.” (10) Page 22 of 61 Theme three: Time constraints This theme includes sub themes of waiting lists, appointment times, and time pressures on cancer specialists. A common theme was time constraints within the NHS. Four participants (33.3%) mentioned long waiting lists for physiotherapy and pain clinic appointments which were a concern as sometimes patients with cancer did not have time due to their disease. “So, um, this is not related to his lymphoma so currently he's waiting from an appointment with the experts at the back clinic which is a 4 month wait.” (2) “Um, in general because there's, sort of restrictions on how much time the physios have to see patients.” (3) “There are a lot of patients that probably would benefit from things like physiotherapy but the NHS we know that there is a very long waiting list.” (9) One participant described their oncology appointments as short 15 minute slots. “If you see my clinics unfortunately they have 15 minute slots at which time I need to see how they get on with their chemo or any new symptoms make them a management plan so we will not have the time to discuss about all the other things around their lifestyle.” (12) One participant had a concern that should manual therapy training become available time pressures would make this a low priority due to existing time pressures. “We are all very busy and have a lot of pressure on our time. So, in the scheme of things if we were to have a seminar on osteopathy and its benefits verses the newest chemotherapies and its toxicities then I would have to say that the osteopathy one would lose.” (1) Page 23 of 61 Theme four: Manual therapy effects This theme was divided into sub themes of positive and negative effects Massage, spinal manipulation and lymphatic drainage were discussed. 100% of participants had something to contribute regarding the benefits associated with manual therapy and 0% had come across negative effects associated with manual therapy on patients with cancer. Positive effects on pain, mood and lymphoedema 11 participants (91.7%) thought manual therapy could help reduce lymphoedema (33.3% weakly), improve mood (50% weakly) and reduce pain (58.3% weakly). The types of pain described were: degenerative, tension pain, muscle spasm and misalignment of joints. Effects on mood were described as inducing relaxation, a positive effect on mental state, endorphin release, therapeutic interaction, distraction technique, placebo and reduction of anxiety. “Well, regardless of whether there is any evidence for it there will always be a placebo benefit to manual therapy because you are having a one to one interaction with a patient.” (11) Positive effects on function 10 participants (83.3%) felt that manual therapy might be able to help with fatigue (75% weakly). Eight participants (66.7%) felt manual therapy could help joint stiffness attributed to muscle spasm, reduction in function and immobility. Four (33.3%) felt manual therapy might help improve immune function. Page 24 of 61 ” Improving the mobility of the joint or um, helping them to improve their movement probably has a beneficial knock on effect, err, you know it may sort of improve things that they may not require pharmaceutical intervention.” (3) “So if you've had a breast cancer patient that's had a breast operation and then they have got shoulder stiffness that is limiting your ability to give radiotherapy or something then you might refer to a hospital physiotherapist to work on that so that we can then give treatment.” (3) Feeling of control Three participants (25%) felt strongly that manual therapy helped patients regain a sense of control in their treatment. The nature of the disease and hospital treatment involves patients having things done to them and often results in feeling a loss of control. “It gives them a feeling of control. Because cancer, one of the main issues is that you are not in control.” (2) “Often patients feel something is being done and if it’s of benefit to them then yes that can give them a sense of control because when they are in hospital so much is taken out of their control. Having a lot of things done to them.” (5) “Yeah I think it's not just passive. You are not just laying there waiting for the next drip to come along.” (8) Negative effects on bone density Eight participants (66.7%) had concerns the presence of bony metastases could weaken bones resulting in an increased risk of fracture. One (8.3%) felt prostate metastases resulted in increased bone density. “I suppose the cervical spine is a particular area to avoid. In terms of things to be cautious about I think bony metastasis or a risk of osteoporosis whether it's brought about by menopause or by medical treatments.” (9) “I suppose there is the risk of some causing deterioration of bony disease if you are manipulating bones and joints that have cancer in them. You could give them a pathological fracture. Worst case, even, cord compression”. (11) Page 25 of 61 Other possible negative effects described were: Increased bruising with low platelet count, increased risk of infection spread to immune compromised patients, sore skin from radiotherapy and the movement of blood clots with massage. Concerns about spreading cancer No participants had concerns the technique modalities of joint manipulation, articulation and lymphatic techniques would spread cancer further in the body. Concerns were that treatment might cause further discomfort. “I'm not worried about spread of cancer. Basically once the cancer has got to the spine it is incurable anyway.” (1) “I don't think spread really it's more about underlying fragility” “No, I'm assuming that is a myth. What I worry about is that they might hurt from the treatment itself not that the cancer might spread.” (8) “No, no. More as to how the patient will feel afterwards and of course with regards as we said to the bone mets is risk of fractures, sprains, things that may make the patient feel more unwell.” (9) Two participants (16.7%) were concerned massage directly onto a tumour site might cause the tumour to spread. These participants refer for massage stating that they trust the massage therapists to avoid tumour sites. “If somebody had a big tumour in their abdominal wall that was obviously palpable, Um, I think if somebody vigorously massaged that and pushed it about then it is possible that some cells might fly off. But, I think that most sensible human beings wouldn't undertake that.” (1) “If there is a malignancy in the leg in the muscle and there is massage to that part of the leg then of course there is a risk of spreading it.” (Participant 7) No participants felt the movement of lymph contributed to the spread of cancer throughout the body. One (8.3%) felt that massage avoided lymph nodes and that manual therapy did not influence lymphatic flow around the body. Page 26 of 61 “Not really, lymph glands are in the armpit, or in the groin or in the neck. You don't really massage those.” (5) “What about the influence of manual therapy on the lymphatic system influencing lymphatic flow? No it shouldn't.” (5) One (8.3%) felt manual therapy techniques would not spread the progression of lymphoma (cancer of the lymphatic system) throughout the body although ultrasound and electro therapy might. “They say that you should avoid ultrasound and electro therapy as this may advance the cancer progression.” (2) Page 27 of 61 Discussion Study aim The study explored the experiences and opinions of these cancer specialists on the use and effects of manual therapies on patients with cancer. The study consisted of semi-structured interviews of nine oncology consultants, two cancer nurse specialists and one palliative care registrar with experience either referring a patient for manual therapy or personal experience. The participant sample had expertise in the seven most commonly diagnosed cancers in the UK with the exception of malignant melanoma with reference to CR UK (2011). Referral 10 participants (83.3%) felt their patients discussed their musculoskeletal aches and pains with them, however, no evidence was found supporting the Department of Health (2006) referral to multidisciplinary teams dealing with musculoskeletal symptoms. 10 participants (83.3%) had referred for physiotherapy as recommended by NCAT (2009), however, there did not appear to be a protocol or guideline for referral of musculoskeletal symptoms for patients with cancer. Each specialist described a clinical decision to first rule out cancer as the underlying cause then recommended either analgesia or referral to one of the following: physiotherapist, a cancer nurse specialist, massage therapist or back to the GP. Factors described influencing referrals were: the existence of bony metastases, patient ability to cope with further treatment, long waiting lists and patient finance. Existing research found a small percentage of cancer specialists refer or recommend therapies such as osteopathy or chiropractic care to their patients with a larger percentage in favour of massage therapy. Hann et al (2004) reported 40% of Page 28 of 61 oncologists recommended chiropractic treatment and 84% recommended massage. The study findings seem to support this with 16.7% recommending patients consider osteopathy and 75% recommending massage, further research is required to investigate this finding. Two oncology consultants (22.2%) that recommended patients consider osteopathy or chiropractic treatment had positive personal experiences. A correlation between personal experience and referral recommendation was identified by Samano et al (2005) where 22% of oncologists questioned had personal experience and recommended osteopathy or chiropractic treatment. This could suggest the study findings support research by Samano et al (2005). Future research could explore this potential relationship. Understanding of manual therapy A lack of awareness of the level of training covered in the osteopathic profession was identified and specifically if identification of pathologies were covered. “You know, I think I would hope that in manual therapists training they also train to be aware of what the red flags would be with regarding cancer.” (1) Eight participants (66.7%) that had a limited understanding of osteopathy or chiropractic treatment attributed it to personal or patient experience with no formal training. One nurse and one palliative care registrar had undertaken training on manual therapy. Page 29 of 61 The main condition participants described helped with osteopathy was back pain which is recognised by the NICE (2009). Other conditions described included muscle soreness, balance problems and repetitive strain injuries. Seven oncologists (77.8%) commented on the lack of evidence base for osteopathy as a factor in their ability to recommend it to patients. This suggests support for the findings of Hyodo et al (2003) and Samano et al (2005) where oncologists were unable to advise patients on complementary therapies due to a lack of supportive evidence base. “a lot of our treatments are based around evidence based medicine and as you know a lot of complementary medicine is not evidence based.” “I understand that it is very difficult to do a randomised blind trial of some complementary therapies. It's also about numbers.”(10) Implications for patient care Despite the lack of training and evidence base 100% of participants perceived benefits from the application of manual therapy on patients with cancer. “Well, regardless of whether there is any evidence for it there will always be a placebo benefit to manual therapy because you are having a one to one interaction with a patient. You are just physically giving them attention. That makes people feel better.” (11) “My feeling is that If that helps a patient get through their treatment and helps them cope with their cancer diagnoses and in itself doesn't do harm or effect the cancer treatment and they are fully informed and aware and I must admit they are financially able to do it then I have no problem with it.” (10) Page 30 of 61 Benefits 11 (91.7%) felt manual therapy could reduce pain levels and improve mood. Research by Kutner et al (2008), Schneider & Gilford (2008) and Jane et al (2009) support these views. Larger participant samples, and control groups would improve future studies. Schneider & Gilford (2008) and Hojan et al (2011) demonstrated manual therapies improving mobility and range of movement in individual case studies and eight participants (66.7%) agreed. Clemens et al (2010) demonstrated symptomatic relief from lymphatic drainage which can also improve pain and range of movement. Participants were uncertain of a benefit to the immune system with four (33.3%) suspecting some benefit. Stringer (2008) identified a temporary reduction of cortisol levels and Noll et al (2010) found reduced antibiotic duration and hospital stay. 10 participants (83.3%) suspected that manual therapy may reduce levels of fatigue. Participants agreed with Hann et al (2004) that patients pursued manual therapies like osteopathy to regain a sense of control over their situation and restoration of agency is an important concept in patient care. “If the patient feels that they have instigated the treatment it helps them regain a sense of control over their condition. Um, a lot of the time people having stuff like radiotherapy or chemotherapy, there is this perception that it is something that is done to them. “(1) Massage was identified by nine participants (75%) to be an established treatment modality that is integrated into standard medical treatment because of its inclusion in the hospitals today. Page 31 of 61 Risks Eight (66.7%) were concerned about an increased risk of fracture in patients with bone metastases. Existing research by Howe (1993), Davis & Taylor, (2007), Roudier (2008) and Shah & Salzman, (2011) support this view describing a reduction of bone mineral density in bone metastases increasing the risk of fracture. One participant stated that bone density increased in prostate cancer however, a small study of 12 cadavers by Roudier (2008) found although the radiographic appearance appears to show increased bone density this is still associated with an increased risk of fracture due to the additional bone material being weak. According to Shah & Salzman, (2011) spinal metastasis occurs in 60-70% of systemic cancer patients but only 10% of spinal metastases were symptomatic which implies extreme caution should be used as patients with spinal metastases are unlikely to be aware of their presence. Manual therapists should consider this possibility in their treatment approach. Cox (2010) found osteopaths were concerned about the use of lymphatic pumping techniques on patients with cancer in case this spreads cancer throughout the body. Wu et al (2010) theorise manipulation may serve as a mechanism to spread tumour cells in osteosarcoma as patients had a significantly poorer 5 year survival rate. In contrast, participants interviewed had no concern manual therapy techniques of joint manipulation, articulation or lymphatic techniques might spread cancer. This highlights a discrepancy between manual therapy perceived effects on the body between cancer specialists and osteopaths. “I don't think spread really it's more about underlying fragility” “No, I'm assuming that is a myth. What I worry about is that they might hurt from the treatment itself not that the cancer might spread.” (8) Page 32 of 61 One participant stated that manual therapy did not affected lymph at all. Whether lymph is moved or not highlights a further discrepancy between the osteopathic perception of treatment effects on the body and that of the oncologists. Collaboration and discussion of perceived treatment modality effects is required to research this further. Two oncologists (22.2%) interviewed shared the views of Lerner (1994) and The International Society of Lymphology (2003) that direct mechanical compression could promote tumour cell mobilisation. However, these oncologists were confident that the hospital massage therapists would avoid the tumour sites. Existing research into this area appears limited and inconclusive. Implications for osteopathy 11 participants (91.7%) thought there could be a role for osteopathy in the care of patients with cancer. The most popular reasons given were the symptomatic relief of musculoskeletal pain, improved mood, improved function, regain a sense of control, and to avoid long waiting lists of existing hospital services. Osteopathy Guide (2010) agreed and suggested patients with cancer might use osteopathy to help cope with the side effects from chemotherapy and radiotherapy. Negative personal or second-hand experience did not result in participants excluding a role for osteopathy in the care of patients with cancer. Participants felt long NHS waiting lists for physiotherapy or pain clinics can deter referral and can delay treatment implying a role for osteopathy. Barriers to osteopathy identified in the study agreed with Bengough (2010) as: a lack of referral guidelines, a lack of knowledge of osteopathy and understanding of Page 33 of 61 the level of osteopathic training. In addition further barriers identified were: poor evidence base to support osteopathy, concern about an increased fracture risk, concern about cost, and uncertainty of availability versus the convenience of existing hospital services. Participants recommended contacting oncology consultants to check if treatment is considered safe on a patient with cancer. The preferred contact method was via telephone. Study Limitations The small study sample means the findings are unlikely to be applicable to the UK professional oncology community and it is inappropriate to make any conclusions from such a small qualitative study. A larger study sample would be beneficial. An element of bias is expected due to self selection however, it is important to note two participants had negative stories associated with manipulation treatment, one from a first-hand experience with a patient and the other from a second-hand story. The competence of the interviewer may have affected the validity of data collected. Two telephone interviews were conducted due to difficulty obtaining participants and their location. These interviews may have missed important data due to the absence of non verbal cues. Seven participants experienced interruptions during the interview process and participants had time constraints which was a result of responsibility of care to patients. The interviewer inexperience, interruptions and time constraints resulted in inconsistencies between questioning depth. Page 34 of 61 No prior knowledge of the interview questions meant it was difficult to be confident in participants recall ability. A future design would benefit from advance notification of the interview questions. The response rate of 8.75% was lower than the anticipated conservative estimate of 10% when compared to previous research by Samano et al (2005) who achieved an 18.2% response rate. Further research Further research is required to support osteopathic treatment on patients with cancer such as case studies or survey the opinions of patients with cancer that have undertaken osteopathy. Other possible studies could interview GPs, cancer nurse specialists, physiotherapists and the massage therapists that work on oncology wards. It might be beneficial to give talks on osteopathy at oncology conferences to inform cancer specialists on the level of training of osteopaths and the potential risks and benefits of treatment. Participants recommended: Attending oncology conferences to describe patient case studies, Circulate a questionnaire survey of cancer specialists working in hospices on their opinions and experiences of manual therapy on patients with cancer as they were described as more likely to come across complementary therapies. Page 35 of 61 Conclusion The study demonstrated a potential role for osteopathy in the treatment of patients with cancer to fill a gap in the care of musculoskeletal symptoms in patients with cancer. Barriers to referral or recommendation for osteopathy were identified as: no existing referral guide or protocol for musculoskeletal symptoms in patients with cancer, lack of understanding of treatment, lack of understanding of the level of osteopathy training, lack of supportive evidence base and uncertainty of availability and cost. Benefits associated with osteopathy on patients with cancer were described as improved pain levels, mood, mobility, range of movement and regaining a sense of control in treatment. No negative effects of manual therapy on patients with cancer were identified in the study. Perceived risks associated with osteopathic treatment on patients with cancer were seen as: an increased risk of fracture due to a reduction in bone mineral density with bone metastases and concern that massage directly onto a tumour might promote metastatic spread. Other concerns were a risk infection spread to immune compromised individuals and bruising. An important finding was a discrepancy between perception of the effects of manual therapy on the body and between osteopaths and oncologists. Future interdisciplinary collaboration would be beneficial to explore this. Interdisciplinary dialogue between cancer professionals about manual therapy on patients with cancer would be beneficial as most participants had not discussed manual therapy with colleagues. Page 36 of 61 Future research would be beneficial into individual case studies on the effects of osteopathic treatment on patients with cancer. A presence at oncology conferences would be beneficial to increase awareness, understanding and referral to osteopathy. The osteopathic profession would benefit from publicizing the level of training involved in becoming an osteopath, specifically the training to recognise pathology and identify red flags. Word count: 5,460 Page 37 of 61 Acknowledgements In no particular order I would like to thank: The consultants and cancer specialists who gave up their valuable time to participate in this study making this research project possible. My supervisor Mr Chris Thomas for encouraging me to pursue an area of interest and being 100% supportive despite knowing that I had to go through the marathon NHS Ethics application process. Thank you for your patience and diligence Mrs Elliann Fairbairn from the National Cancer Research Institute, Mrs Hilary Abbey, Mr Danny Church, Mrs Hannah Kirshaw, Professor Johnson, Miss Aimee Cox for their support and advice. Thank you to my family for their love and support throughout my studies. Page 38 of 61 References Bengough, L. (2010). Barriers to UK Osteopaths’ Involvement in the Treatment of Patients with Life Limiting Illnesses. Unpublished Degree Dissertation. The British School of Osteopathy, University of Bedfordshire. British School of Osteopathy (2008). Guide to Research Methods/Study Types for IE/CAE Projects. British School of Osteopathy. Cancernet UK (2011). Osteopathy & chiropathy [Internet] Available from: http://www.cancernet.co.uk/comp-osteop.htm [Accessed: 14/02/2012]. 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The journal of bone and joint surgery. Volume 92, Pages 1580-1585. Page 45 of 61 Appendices Principle research questions: Could Osteopathy provide complementary assistance in cancer care? What are the benefits and risks associated with the different treatment techniques on symptoms of patients with cancer? Secondary research questions: What symptoms cause Oncologists to refer cancer patients to a manual therapist? What type of manual therapist do Oncologists refer cancer patients to? Do Oncologists have a regular dialogue with manual therapists? Do Oncologists believe that manual therapy may increase the risk of metastatic spread? Page 46 of 61 Appendix 1 Participant Information Sheet Study Title: An interview into Oncologists experience and opinion of osteopathic treatment of patients with cancer You are invited to take part in a research study to explore the role of manual therapies in the treatment of symptoms related to cancer or other concerns of cancer patients but not the treatment of cancer itself. Manual therapies for the purpose of this study include: osteopathy, chiropractic care and massage. Before you decide if you would like to take part in this research study we would like you to understand why the research is being done and what it will involve for you. Who is organising this research? My name is Dawn Hammond, and as a 4th year undergraduate Masters of Osteopathy student at the British School of Osteopathy, I am undertaking this research study as part of my final year dissertation. If required I will be more than happy to go through the information sheet with you and answer any questions you may have. Please read the following information carefully and feel free to discuss it with others. My supervisor is Mr Chris Thomas a qualified practicing osteopath and clinic tutor at the British School of Osteopathy. What is the purpose of the study? This study aims to gather Oncologists opinions of the use of manual therapy on patients with cancer, to identify the perceived benefits and risks, investigate inter-practitioner communication between cancer specialists and manual therapists, to exploring Oncologists’ experiences of treating cancer patients who utilised manual therapies. The study aims to investigate the role for Osteopathic care of patients with cancer. There is little research into Oncologists opinions of manual therapy, it is anticipated that the interview will enable exploration of Oncologists personal views and experiences which may contribute to inform manual therapists working in this field Why have I been invited? You have been identified as a practicing Oncologist from an online consultant database Dr Foster (2010) recommended by the Royal College of Physicians or by the National Cancer Research Network. A preliminary questionnaire has been sent to 100 Oncologists within 50 miles of the British School of Osteopathy and a 50 mile radius of my home postcode. This preliminary questionnaire aims to identify practicing Oncologists having referred a patient for manual therapy whilst under their care. If you choose to take part you will be participating in a group of no less than 8 interviewees. Do I have to take part? Page 47 of 61 It is up to you if you decide to join the study. Participation is not required and not participating will not affect your standing as a professional. You are free to withdraw at any time without giving any reason and withdrawal is without penalty or detriment. What will the interview involve? The interview will last approximately 30 minutes and will be recorded on a digital voice recorder. A series of questions will be asked which aim to investigate your experience and opinion of the use of manual therapy on patients with cancer. You can ask questions to the interviewer at any time during the interview. You can decline to answer any question without giving a reason. You are advised to contact the research supervisor in the unlikely event that you should you feel any distress as a result of the interview. You can withdraw from the study at any time without giving a reason. Withdrawal is without penalty or detriment. What do I have to do? If you agree to take part you will need to complete and sign one consent form and the preliminary questionnaire, seal and returned in the SAE provided within 2 weeks of receiving them or by the 1st of November 2011. Early September 2011 you will be contacted on the day/time you indicate on your consent form to arrange the interview. The interview will be arranged for a mutually convenient time and location in a quiet room as the interview will be digitally voice recorded or over the telephone. You have the option to amend and confirm the content of the interview transcription. If you choose to do this the transcription will be sent to you and you will need to complete your preferred changes and send it back in the SAE by the 01st December 2011 otherwise the original transcription will be used. What are the possible disadvantages and risks of taking part? You need to be comfortable that you are giving up at least 30 minutes of your valuable time in order to complete the interview. What are the possible benefits of taking part? By contributing your personal opinion and experience you will be helping inform manual therapists and students reading this research study on their care of patients with cancer. Patients or relatives of patients with cancer may read this research study and it may inform them of Oncologists thoughts on the risks and benefits of manual therapy. There will be no direct benefits received from participating in the study What if there is a problem? If you have any concerns, anxieties, complaints, or feel harmed in any way as a result of this study please contact myself or my supervisor using the details at the end of this document. Page 48 of 61 You can withdraw from the study at any time without giving a reason and withdrawal is without penalty or detriment. If you decide to withdraw from the study please contact myself or my research supervisor. Will my taking part in the study remain confidential? Your name, signature and contact method will be required on the consent form. This will be kept strictly confidential and stored securely with the interview recordings at the British School of Osteopathy by the research department accessible by myself, my supervisor and the research team. After a period of 6 years the consent form, interview recording and preliminary questionnaire will be destroyed. You will be allocated a unique participant identification number against which your interview will be transcribed and the data described so that your participation remains anonymous. You will be reminded at the start of the interview that no patient or practitioner names should be used or details that may lead to identification to protect anonymity and data confidentiality. If this happens by mistake it will not be included in the document transcription of the voice recording or in the study. The interview recordings will be stored in an encrypted file on my password protected laptop which is and backed up on the British School of Osteopathy secure server until the data has been transcribed when it will be copied onto a CD and deleted from my laptop and the secure server. The CD will be stored securely with the consent forms by the research department to be destroyed after 6 years following completion of the study. My supervisor, the research team at the British School of Osteopathy and I will have access to the interview recordings which will be stored securely at all times. The interview recording will be transcribed onto a word document by myself and one other 4th year masters student of Osteopathy to check to check reliability of the interview transcription. This student will not have access to consent forms or participant identities. This process is to check reliability of the data transcription. What will happen to the results from my study? The results will be used to write my 4th year dissertation. The interview data will be transcribed and analysed in order to identify themes and to generate conclusions. A copy of this dissertation will be held in the library at the British School of Osteopathy after July 2012. If you would like a copy please indicate on the consent form whether you would like a summary or full version of the study and where to send the copy, a copy will be sent to you in July 2012. The results may be disseminated to a wider audience through publication. Brief anonymous extracts may be used in the dissertation. You will not be identified in any report or publication. Please keep this sheet for your information. Thank you for taking the time to read the information sheet. Our contact details are given below should you have any questions or want any further information. Page 49 of 61 Researcher details: Name: Miss Dawn Hammond Address: The British School of Osteopathy, 275 Borough High Street, London, SE1 1JE Email Address: [email protected] Supervisor details: Name: Mr Chris Thomas MA (Med Ed), BSc (Hons) Ost, Address: The British School of Osteopathy, 275 Borough High Street, London, SE1 1JE Email Address: [email protected] Telephone Number: 0207 089 5341 Page 50 of 61 Appendix 2 Consent form CONFIDENTIAL Participant Identification Number: CONSENT FORM Title of Project: An investigation into oncologists experience and opinion of osteopathic treatment of patients with cancer Name of Researcher: Miss Dawn Hammond Name of Supervisor: Mr Chris Thomas 1. 2. 3. 4. 5. 6. 7. 8. 9. Please tick where appropriate: I confirm that I have read the information sheet for the above study and have had the opportunity to ask questions. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason and without penalty or detriment. I understand that the interview will be voice recorded and typed up in full. I understand that the recording will be stored and transported securely at all times. I understand that the recordings will be used solely for this study. I understand that the data collected will be retained securely by the research department for six years before it is erased. I understand that no personal details, patient names or practitioner names will be used during the interview in order to protect anonymity and confidentiality. I understand that brief anonymous extracts from the interview may be reproduced in academic presentations, academic and non-academic publications. I agree to take part in the above study. 10. . I would like a copy of the transcribed interview to check accuracy and to have the opportunity to include additional comments, amend or delete my comments prior to data analysis. Send the transcription to: 11. I would like to receive a full copy / summary of the results (circle as appropriate). Please send the results to: Please indicate when it would be best to contact you in order to arrange the interview and the best method to contact you: 12. Day/Time: Contact method: Page 51 of 61 Name of Participant Signature Date Researcher Signature Date Researcher: Supervisor: Miss Dawn Hammond Mr Chris Thomas MA (Med Ed) BSc (Hons) Ost FHEA C/o British School of Osteopathy 275 Borough High Street London SE1 1JE. C/o British School of Osteopathy 275 Borough High Street London SE1 1JE. 1 copy for the researcher: 1 copy for the participant Page 52 of 61 Appendix 3 Preliminary Questionnaire Thank you for your time to complete this questionnaire. Participant reference number: Title of Project: Name of Researcher: Name of Supervisor: An interview into Oncologists experience and opinions of osteopathic treatment of patients with cancer Miss Dawn Hammond Mr Chris Thomas Please tick as appropriate: 1. Has a patient of yours undertaken osteopathic or Yes No Unknown manual therapy whilst in your care? 2. Have you referred/recommended a patient with cancer Yes No for any of the following: osteopathic, chiropractic or physiotherapy whilst in your care? 3. Would you be willing to take part in a 20 minute Yes No interview to discuss the use of manual therapy on patients with cancer? I would not like to take part in this study, please do not 4. Yes send me any further correspondence 5. What is your current position? Grade or role? How long have you been in this position? 6. Do you have any personal experience with any of the following therapies: Chiropractic Yes No Massage Yes No Osteopathy Yes No Others (please specify) Yes No 8. What is your area or areas of specialisation? 8. How old are you? <30 30-40 Are you: Male Female 9. 41-50 >51 Please return this questionnaire in the SAE provided by 1st of November 2011. Researcher: Dawn Hammond Post: C/o BSO, 275 Borough High Street, London, SE1 1JE Page 53 of 61 Appendix 4 BSO REC Committee response Student Number: 803723 Name: Dawn Hammond Supervisor: Chris Thomas Title: An investigation into oncologists experience and opinion of osteopathic treatment of patients with cancer 14 May 2011 Dear Dawn Outcome: Approved Thank you for your application to the BSO REC. I’m happy to say that your application has now been approved and you’re free to begin your project. If you encounter future issues and wish to make any changes to the protocol then please do not hesitate to contact REC Secretary Sam Keeping on either [email protected] or 0207 089 5330 who will advise you on how to proceed. Let me take this opportunity to wish you the best of luck with your study. Yours sincerely, Dr Jo Zamani BSO REC Chair The British School of Osteopathy Research Ethics Committee Research Centre, Room 2.02, 275 Borough High St, London SE1 1JE. Tel: 0207 089 5330 Please direct all queries to BSO REC secretary Sam Keeping ([email protected]). www.bso.ac.uk Registered in England No. 146343 Registered Charity No. 312873 Registered Office: As above The British School of Osteopathy is a registered charity which educates student osteopaths, treats patients and promotes research. Page 54 of 61 Appendix 5 NHS REC Committee response 10th August 2011 Hi Dawn Following our telephone conversation this morning, this is just to advise that, as requested your application has been withdrawn from the County Durham & Tees Valley REC Proportionate Review Meeting scheduled for 19 August. This is because you confirmed that you will not be starting your research before 1 September, and as your project involves NHS staff only, who will be participating in their professional role, this will not legally require NHS ethics review. From 1 September the revised Governance Arrangements for Research Ethics Committees (Harmonised Edition) comes into effect. Excerpt from Governance Arrangements for Research Ethics Committees - A Harmonised Edition as follows: Other Exclusions 2.3.12 - Employers owe a duty of care to their employees. It is different from the duty of care that care providers owe to users of their services. RECs are not expected to assume employers' responsbilities or liabilities, or to act as a substitute for employers' proper management of health and safety in the workplace. It is for employers to ensure that they are fulfilling their duties as employers when their employees take part in research. Research involving staff of the services listed in paragraph 2.3.1 who are recruited by virtue of their professional role, does not therefore require REC review except where it would otherwise require REC review under this document (for example, because there is a legal requirement for REC review, or because the research also involves patients or service users as research participants). For more detailed guidance you should refer to the full document http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidan ce/DH_126474 There is a link from the NRES website at http://www.nres.npsa.nhs.uk/applications/guidance/governance-and-directives. If you have any further queries please do not hesitate to contact me. Many thanks Regards Leigh Leigh Pollard Acting Manager - North East REC Centre Page 55 of 61 Appendix 6 Research and Development Department response: 18th April 2011 Dear Dawn Further to our telephone conversation, I can confirm that the study does not constitute research and you don’t need to register it with the R&D office. Should you have further queries – please feel free to contact me. Kind regards Salma Salma Kibaida R&D Governance Specialist Page 56 of 61 Appendix 7 Interview schedule Introduction Thank you for agreeing to take part in this study and for giving up your valuable time. I would like to remind you this interview will be recorded. Are you happy to continue? Please refrain from using patient or practitioner names or identifiable details so all the data remains anonymous. You can stop the interview at anytime without giving a reason. Interview Questions 1. To begin, could you please tell me what your understanding of osteopathy is? 2. In your training to date can you tell me about any training on manual therapies such as physiotherapy, massage, chiropractic or osteopathic treatment? 3. Do your patients discuss musculoskeletal symptoms with you? 4. Do you refer or recommend patients with musculoskeletal symptoms for manual therapy? • What therapy? • Is there a guideline to follow? • Do many of your patients self refer for manual therapy? • Do patients discuss other treatments they pursue? 5. Can you tell me about a patient that undertook Osteopathic/Manual therapy treatment while in your care? • What type of cancer? • Did you refer this patient? • Why that therapy? • Did you specify the treatment? • Did you have a regular dialogue with the manual therapist? • What were the outcomes of the manual therapy treatment? • Did you have any concerns about the treatment given? • Do you know of any adverse effects? • What do you think were the positive effects? 6. What do you think about the use of the following treatment on a patient with cancer? • Joint Manipulation HVLA • Articulation • Massage • Benefits/Risks 7. In a patient with cancer are there any areas of the body that should be avoided by manual therapists? Page 57 of 61 8. What do you think might be the positive effects of manual therapy on a patient with cancer? 9. What do you think might be the negative effects of manual therapy on a patient with cancer? 10. Would you recommend or consider manual therapy to help patients with cancer with any of the following symptoms? • Pain? • Lymphoedema? • Joint stiffness? • Immune function? • Depression or stress? • Fatigue? 11. How do you believe other Oncologists view manual therapy treatment on cancer patients? 12. How do you feel about interdisciplinary communication with manual therapists? 13. Do you think there could be the role of Osteopathy in the care of patients with cancer? Have you any questions for me? Thank you very much for you time. Page 58 of 61 Appendix 8 Letter of Invitation Version: 1.0 Date: 28th July 2011 The British School of Osteopathy Borough High Street London DATE 05th October 2011 Dear Sir/Madam, th I am a 4 year undergraduate student at the British School of Osteopathy preparing my final year research project. My aim is to interview oncologists on their experience and opinion regarding osteopathic treatment and manual therapy on patients with cancer. I am interested specifically in the use of massage, joint manipulation and lymphatic drainage. Would you be willing to be interviewed? I estimate the interview to take approximately 30 minutes, and to be conducted in October/November 2011. No names (interviewees, practitioners or patients) will be used to respect confidentiality. A copy of the research project will be made available to you should you be interested in the findings on completion. Please specify your preference on the consent form. Please read the patient information sheet if you would like to take part in this study please complete the preliminary questionnaire and consent form and return both forms in the SAE envelope provided. If you would not like to take part in this study please complete and return our preliminary questionnaire in the SAE provided. Thank you for your time taken to read this. Yours faithfully, Dawn Hammond B.S.O. Undergraduate student Page 59 of 61 Appendix 9 Interview data schematic diagram Page 60 of 61
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