Objective To determine the feasibility and acceptability of acupuncture in managing fatigue and well-being in breast cancer survivors.
Methods A randomised controlled trial compared acupuncture was with sham acupuncture and wait list controls was performed in Sydney, Australia. A total of 30 women with fatigue following breast cancer treatment participated in the trial. Women received six sessions of acupuncture over 8 weeks. Outcomes related to an assessment of interest to participate in the trial and identification of appropriate recruitment strategies, appropriateness of eligibility criteria and compliance with treatment attendance. Clinical outcomes assessed fatigue and well-being. In-depth interviews were undertaken with seven women, who described their experience of acupuncture.
Results Our study demonstrated feasibility with appropriate trial entry criteria, good acceptability and treatment compliance with the study interventions, and with the completion of outcome forms. There was a significant reduction in fatigue for women receiving acupuncture compared with control after 2 weeks mean difference (MD) 5.3, 95% CI 4.5 to 6.2, p=0.05, and a significant improvement in well-being at 6 weeks for acupuncture compared with the sham and wait list control, MD 2.7, 95% CI 2.1 to 3.2, p=0.006. Women described their experience of acupuncture positively, and interview data may also offer explanations for the improved outcomes of well-being, with women reporting an improvement in sleep, mood and relaxation.
Conclusions Fatigue is a common symptom experienced by people recovering from treatment, and an appropriately powered trial to evaluate the effect of acupuncture is needed.
Clinical Trial Registration Australian New Zealand Clinical Trials Registry, www.anzctr.org.au ACTRN12610000720011.
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Persistent and severe fatigue following breast cancer treatment is estimated to affect over one-third of patients.1 ,2 Fatigue is characterised by exhaustion and an inability to engage in daily living activities, even after periods of rest. Accompanying symptoms may also include an inability to concentrate and a lack of motivation to do anything.3 Management of fatigue may involve treatment of any contributing factors, with additional treatment including education and counselling, exercise, psychosocial interventions or pharmacological interventions. However, the effectiveness of these interventions is not well established providing an opportunity for self-care and complementary treatments to be investigated.
Five studies examining the feasibility of acupuncture to manage fatigue have been reported. Two observational studies reported a reduction in symptoms of fatigue.3 ,4 These promising studies initiated further study using controlled designs. Molassiotis et al5 compared acupuncture with acupressure and sham acupressure. At the end of the intervention there was a 36% improvement in fatigue in the acupuncture group compared with 19% in the acupressure group and 0.6% in the sham acupressure group. Balk et al6 compared acupuncture with sham acupuncture and found changes in fatigue, fatigue distress, quality of life and reduced depression in both groups in their pilot study of 27 participants receiving the intervention during cancer treatment. This study also highlighted poor feasibility related to the use of the Park sham device and problems with logistics and recruitment. The most recent trial examined the feasibility of delivering a patient education package integrated with acupuncture compared with usual care.7 A promising effect was found, although recruitment was problematic with only 13 participants randomised. To date the evidence of effectiveness for the management of fatigue using acupuncture is unclear, with research highlighting problems of feasibility. We undertook a study to examine the feasibility and acceptability of acupuncture with managing fatigue and well-being in breast cancer survivors.
Trial design and participants
We conducted a mixed method randomised controlled trial, comparing acupuncture with a sham and a wait list control.
The University of Western Sydney Human Ethics Committee approved the research (H7731). Women were eligible to join the study if they were aged between 18 and 70 years with a diagnosis of breast cancer, a score of 4 or more on the Brief Fatigue Inventory (BFI)8 and completed chemotherapy at least 1 month previously. Exclusion criteria included women with severe anaemia or active treatment for anaemia, anticipated survival less than 3 months, scheduled cancer treatment (chemotherapy or radiotherapy) during the study, fatigue prior to cancer diagnosis, or concurrent use of acupuncture. An independent researcher was responsible for the computer generated randomisation schedule, and the allocation of the randomisation sequence was concealed using sealed envelopes.
The acupuncture intervention is described according to Standards for Reporting Interventions in Clinical Trials of Acupuncture recommendations.9 Women in the acupuncture and sham control groups received a diagnosis based on the Traditional Chinese Medicine (TCM) style, with diagnosis primarily based on syndrome patterns.10 Treatment was administered twice weekly over 3 weeks and then weekly for the final 3 weeks. Six acupuncturists registered with the Australian Acupuncture and Chinese Medicine Association administered the acupuncture. All needles were inserted using a Park device.11 This device consists of a base with a hole in the centre and sticky tape at the bottom. From the top of the base extends a double tube, which continues into the central hole of the base. This allows the needle to be inserted through the tube and base to the chosen point, and holds the needle in place. For both groups needles were retained for a minimum of 20 min, with the duration of each treatment lasting 45 min. Practitioners were advised to demonstrate empathy, respect and a pleasant manner with all study participants.
Women in the acupuncture group received five points administered at each session (bilateral KI3, KI27, ST36 and SP6 and unilateral CV4 and CV6). These points have been used in previous research suggesting a therapeutic effect.3 In addition up to three secondary points were used, their selection based on differential diagnosis from the TCM paradigm. Practitioners administered a mean total of 1.9 (range 1–5; 2 treatment violations were identified) points in addition to core points. Acupuncture needles were stimulated manually. Single-use disposable stainless steel Vinco needles (0.25×40 mm and 0.22×25 mm) were used. All participants received the de qi sensation (a needling sensation of soreness, numbness or heaviness) following initial insertion and once more during treatment. Reinforcing or reducing stimulation was given according to the TCM diagnoses. Needles were inserted to depths according to standard texts.12 Practitioners were instructed not to administer moxa, herbs, massage, or laser.
Women in the sham control group received a non-invasive sham needle using the Park device.11 The sham needles were placed on fixed sham points, so called as they were not acupuncture points. Sham points were located on the lower back, abdomen, foot, lower leg and forearm (table 1). The tip of the sham needle is blunted, and skin penetration does not occur.
Women randomised to the wait list control carried on as normal with the researcher (BC) making contact with women fortnightly. Women were offered acupuncture after this time.
Feasibility outcomes included an assessment of interest to participate in the trial and identification of appropriate recruitment strategies, the appropriateness of eligibility criteria and compliance with treatment attendance. Clinical outcomes were assessed at baseline, 2, 4 and 6 weeks. Fatigue was measured using the BFI,8 this includes 9 items measuring the severity of fatigue on a scale between 0–10. Well-being was assessed using the Wellbeing questionnaire (W-BQ12),13 and Measure Yourself Concerns and Wellbeing questionnaire (MYCaW).14 The W-BQ12 is a 12-item scale measuring 4 components of well-being including positive well-being, energy, negative well-being and general well-being. MYCaW requires people to choose ‘one or two concerns which they would most like help with’ and to score the severity of these concerns on a 7-point scale between 0 (not bothering me at all) to 6 (bothers me greatly). They also scored their ‘general feeling of well-being’.
Sample size and statistical analysis
As this was a pilot study it was estimated that a sample of 30 women would be sufficient to provide data to answer our study questions. Outcome data were analysed using an ‘intention to treat’, and the analysis examined the demographic and baseline characteristics of women randomised to the trial. For differences between groups, testing of continuous data was undertaken using analysis of variance. Post hoc adjustments were made to examine differences over time and between groups. Levels of significance were reported at p<0.05. Analysis was performed blind to study group by a study statistician (CT).
Funding was received to conduct in-depth interviews to examine the acupuncture experiences of participants and further exploration of the effects and outcomes they may have experienced. The aim of the interviews was to complement the quantitative outcome measures and to examine the feasibility of using qualitative methods as part of a larger clinical trial. We undertook seven interviews with women from the acupuncture group, who were randomly invited to participate in the interviews. One woman could not be contacted. Interviews were conducted by BC, a junior researcher with the Research Centre. BC received training with conducting in-depth interviews from JMU and JP who are researchers experienced in qualitative data collection and analysis. Interviews explored perceived impact of acupuncture on their sense of well-being and levels of fatigue, and questions about their sessions with the acupuncturist. Interview data were digitally recorded and transcribed verbatim by a professional transcriber. Transcripts of the interviews were de-identified and checked for transcription accuracy. Following a process of thematic analysis15 three researchers (CS, JP and JMU) read the transcripts independently and subjected the data to a process of coding and common elements were identified independently and discussed between the researchers.
The study was administered from the University of Western Sydney. The recruitment strategy included a media release, paid advertisements in local papers, promotion of the study at two local Cancer Support Centres and presentation of the trial to cancer support groups. Promotion of the study led to 84 women making contact with the study centre between April 2010 and February 2011 (figure 1). The media release led to a feature in a New South Wales newspaper distributed throughout the State resulting in 52 enquires from women residing up to 530 km away. Facebook advertising resulted in 18 enquires, 9 enquires were received from cancer support groups and 5 enquires from clinician referral. Almost half of the women declined participation due to the distance to travel to the study acupuncturists. This included women who were too fatigued to travel, but also women who were located long distances from the University and resources were unavailable to support establishing the trial in regional settings. A total of 16 women did not meet the eligibility criteria: 13 were receiving ongoing cancer treatment, 1 woman had insufficient English language skills to enable her to participate in the study and 5 did not meet the fatigue score threshold.
One woman withdrew from the acupuncture group following randomisation but before the first treatment due to an unrelated illness. Compliance with treatments by women in both groups was high: two women receiving acupuncture did not receive all nine treatments, one due to logistics and the other due to pre-existing migraines. Outcome forms were completed by 29 women on 3 occasions.
Baseline data on trial participants are presented in table 2. Most women were in their mid fifties, were on concurrent medication, employed and had completed high school education. The majority of women had used acupuncture previously. The randomised groups were comparable on most baseline characteristics except two W-BQ12 scores (20.7 vs 16.6 vs 20.5). Mean baseline levels of fatigue were described as moderate with scores in the range 4–6. Well-being measured was low with total scores ranging between 16 and 20, with negative well-being the lowest score across groups.
We present the outcome data supported by quotes from women interviewed in the trial with data presented in table 3. Fatigue declined over time for all three groups. There was a significant reduction in fatigue for women receiving acupuncture compared with control after 2 weeks. This was significant for acupuncture compared with the wait list control. At 4 and 6 weeks there was a non-significant trend in reduced fatigue for the acupuncture and sham acupuncture.
Well straight away as soon as I had the acupuncture in the trial, I couldn't believe how good I felt. I wasn't as tired even from the first lot of acupuncture that I had. I noticed a difference straight away. (412)
It has improved my ability to get further in the day with the energy. (403)
W-BQ12 scores improved over time for all three groups, but no significant differences were found between groups. We found no significant changes in patient-nominated measures of well-being (MYCaW) at 2 and 4 weeks but a significant change at 6 weeks with the overall score significantly improved for acupuncture compared with the sham and wait list control. In the interviews, women associated such well-being with feelings of invigoration and empowerment.
Afterwards, the first time I had acupuncture, I came home and went to bed for 2 hours. After I have had every other session, I've gone for a walk or I've felt like I can sit down and write a media release; I just felt quite empowered…I feel like the fogs lifted from my mind. (430)
I remember feeling I could feel invigorated. (418)
Data from the interviews may also offer explanations for the improved outcomes of well-being. Women reported an improvement in:
Sleep: I think the that thing I found most effective was that when I am asleep I'm in a much deeper sleep than I probable was before (426)
Improved mood: I'm feeling emotionally stronger. That happened since I was on the acupuncture so I'm thinking, can I put it down to that? I'd like to think so. (403)
I think happier, yeah. Not quite as anxious as I was. (402)
Relaxation: I felt as though it was a very calming thing for me, every time I had it I fell asleep… I do think it's a very relaxing treatment and I think for anybody that's going through any form of chemo or other aspects associated with cancer, it is an exceedingly relaxing form of treatment. (426)
This suggests that women perceived a change in well-being, which they attributed to their engagement in acupuncture. We also examined expectations prior to the first and last treatment for women receiving acupuncture and the sham control. At baseline both groups held high expectations that acupuncture could be useful with reducing their fatigue (acupuncture 100% vs placebo 90% p=0.9). These expectations remained high at 6 weeks with no differences between groups (80% vs 100%). We also asked women which group they thought they were in. We found no difference between groups at baseline (50% of women receiving acupuncture thought they received acupuncture vs 60% of women receiving the sham control who thought they were receiving acupuncture) and at 6 weeks (70% of women receiving acupuncture thought they were receiving acupuncture vs 50% of women receiving the sham control who thought they were receiving acupuncture). For those participants who thought they were receiving acupuncture (irrespective if they were in acupuncture or sham) their reasons included feeling better (n=5), wanting to be positive (n=1), sensation of needling (n=6), felt energy flow (n=1) and felt no different (n=1). For those reporting to be in the sham group their reasons included no change in symptoms (n=2), felt more relaxed (n=1) and no sensation of needling (n=6).
Our study demonstrated feasibility with appropriate eligibility criteria for the trial, the intervention was acceptable with good treatment compliance by study participants, and with completion of outcome forms. The fatigue instrument (BFI) appeared to be responsive to change from the intervention, supported by data from the interviews, although the small changes in well-being over 6 weeks suggest a review of alternative well-being instruments maybe needed in future research. Recruitment strategies demonstrated interest in the study, although recruitment was slower than anticipated. More timely recruitment is anticipated if the study were to be implemented in a future clinical setting. This study provides preliminary data suggesting that acupuncture may assist with reducing fatigue and improving well-being following cancer treatment.
The study has a number of strengths including randomisation, thereby reducing selection bias and maintaining participant blinding. Our findings are consistent with earlier observational studies,3 ,4 and two controlled trials,5 ,7 indicating a potential benefit from acupuncture. In contrast to the two most recent trials,6 ,7 we did not experience difficulties with the use of the Park sham needles and device among our practitioners. The small numbers of interviews bring a patient voice to this study illustrating their experience of changes in fatigue and well-being, and highlight that sleep, improved mood and increased feelings of relaxation may offer an explanation of how these outcomes were achieved. The study does have some limitations. This was a pilot study and results should be interpreted with caution due to the small numbers. The intervention was of a short duration, and we observed the treatment effect was greatest when acupuncture was administered twice a week. This may indicate a dose response and it is possible that a different dose of acupuncture may lead to different outcomes. However, the treatment protocol was semistandardised allowing the acupuncturists to have some flexibility with their point selection. Feedback from our study practitioners was positive regarding the treatment they administered suggesting there was good clinical validity for the acupuncture protocol.
To address these limitations an appropriate powered study with a more intense dose of acupuncture is planned. We also propose a trial using mixed methods to explore in-depth women‘s experiences of receiving acupuncture or the control, with the aim of providing evidence of the process by which the outcomes from the trial are achieved, or not achieved. Based on the feasibility data the sample size for a future study to be powered at 90% power (α 5%) we would be able to detect a 10% change in BFI scores from baseline between groups with 58 women in each arm of a study.
Although our pilot study relied on self-referral from study participants, the study has resulted in building and strengthening networks between the University and several cancer therapy centres. These collaborations would be used in future research to facilitate referrals from clinicians. Our outreach recruitment strategy would be also used in future research and funding would be sought to provide greater geographical coverage of study acupuncturists, and home visits would be considered. We also plan to undertake a follow-up period in future research.
Fatigue is a common symptom experienced by people recovering from cancer treatment, and an appropriately powered trial to evaluate the effect of acupuncture is needed.
We report a feasibility study of acupuncture for cancer fatigue.
Distance constrained recruitment; compliance was good; reports of acupuncture were positive.
We also wish to thank all women participating in this study.
Contributors CS was responsible for the conception, design of the study, interpretation of the analysis and drafted the articles, BC undertook data collection and commented on drafts of the paper, CT undertook data analysis and commented on the articles, JP and JMU contributed to the design and analysis of the in-depth interviews and commented on the draft of the paper.
Funding We wish to acknowledge the funding from the Cancer Institute for New South Wales, and the donation of needles from Helio Supply Co. Pty. Ltd.
Competing interests None.
Patient consent Obtained.
Ethics approval University of Western Sydney Human ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.