Background Small studies of variable quality suggest that massage therapy may relieve pain and other symptoms. Objective To evaluate the efficacy of massage for decreasing pain and symptom distress and improving quality of life among persons with advanced cancer. Design Multisite, randomized clinical trial. Setting Population-based Palliative Care Research Network. Patients 380 adults with advanced cancer who were experiencing moderate-to-severe pain; 90% were enrolled in hospice. Intervention Six 30-minute massage or simple-touch sessions over 2 weeks. Measurements Primary outcomes were immediate (Memorial Pain Assessment Card, 0- to 10-point scale) and sustained (Brief Pain Inventory [BPI], 0- to 10-point scale) change in pain. Secondary outcomes were immediate change in mood (Memorial Pain Assessment Card) and 60-second heart and respiratory rates and sustained change in quality of life (McGill Quality of Life Questionnaire, 0- to 10-point scale), symptom distress (Memorial Symptom Assessment Scale, 0- to 4-point scale), and analgesic medication use (parenteral morphine equivalents [mg/d]). Immediate outcomes were obtained just before and after each treatment session. Sustained outcomes were obtained at baseline and weekly for 3 weeks. Results 298 persons were included in the immediate outcome analysis and 348 in the sustained outcome analysis. A total of 82 persons did not receive any allocated study treatments (37 massage patients, 45 control participants). Both groups demonstrated immediate improvement in pain (massage, -1.87 points [95% CI, -2.07 to -1.67 points]; control, -0.97 point [CI, -1.18 to -0.76 points]) and mood (massage, 1.58 points [CI, 1.40 to 1.76 points]; control, 0.97 point [CI, 0.78 to 1.16 points]). Massage was superior for both immediate pain and mood (mean difference, 0.90 and 0.61 points, respectively; P Limitations The immediate outcome measures were obtained by unblinded study therapists, possibly leading to reporting bias and the overestimation of a beneficial effect. The generalizability to all patients with advanced cancer is uncertain. The differential beneficial effect of massage therapy over simple touch is not conclusive without a usual care control group. Conclusion Massage may have immediately beneficial effects on pain and mood among patients with advanced cancer. Given the lack of sustained effects and the observed improvements in both study groups, the potential benefits of attention and simple touch should also be considered in this patient population.

Massage Therapy versus Simple Touch to Improve Pain and Mood in Patients with Advanced Cancer: A Randomized Trial

Evaluating the effectiveness of aromatherapy in reducing levels of anxiety in palliative care patients: Results of a pilot study

A systematic review highlights threats to validity in studies of barriers to cancer trial participation

Palliative care researchers face many ethical and practical challenges. In particular, recruitment has proven difficult. New methodologies and methods need to be developed if barriers are to be overcome. This paper presents an example of a participatory approach to research with people receiving palliative care services. The approach was used for recruitment into an in-depth multi-methods study of weight loss and eating difficulties experienced by people with advanced cancer. Methods included a survey of patients on the case-loads of two community palliative care teams working in the South of England in 2003. The questionnaire was returned by 199 patients, 58% of the total patient population under the care of the two teams. 

Benefits of the approach taken are detailed, but also issues that emerged across the course of recruitment, thus highlighting points of interest for palliative care researchers. It is proposed that the success of the recruitment process can be attributed to the adoption of a context specific participatory approach. Successful recruitment into the study challenges the widely held belief that, for practical and ethical reasons, it is inappropriate to study people who are approaching the end of life. It demonstrates that a participatory approach enables clinical practice and research to share decision making and values, leading to a feasible and successful recruitment process that is acceptable to clinicians, researchers and patients.

Seeking new methodology for palliative care research: challenging assumptions about studying people who are approaching the end of life

Distress associated with cancer often presents with symptoms of depression and/or anxiety. Cognitive Behaviour Therapy (CBT) is one of the most effective psychological treatments. Complementary therapies, especially aromatherapy massage (AM), are also popular and alleviate anxiety. No studies have directly compared these two treatments.

Aims: The aim of this study is to (1) test the feasibility of recruitment into a randomised controlled trial of AM versus CBT in patients with cancer; (2) test and modify the intervention; (3) determine whether changes in outcomes were consistent with published data.

Methods: Patients at all stages of cancer, recruited from oncology outpatient clinics and screening eight or more for anxiety and/or depression on the HADS, were randomised to Treatment as Usual (TAU) plus up to eight sessions weekly of either AM or CBT, offered within 3 months. The POMS was collected at baseline and 3 and 6 months post baseline.

Results: Of those suitable, over 60% (39/63) participated (AM, n = 20; CBT, n = 19) and over 90% (36/39) were followed up. Both packages were well received. The preference was for AM, with more sessions were taken up; (Mean number sessions AM = 7.2 (SD 2.0) and CBT = 5.4 (SD 3.1); P<0.05). Significant improvements in POMS (Total Mood, depression and anxiety scores) occurred with both interventions. Between-group comparison showed a non-significant trend towards greater improvement in depression with CBT.

Conclusions: Recruitment was feasible; the interventions acceptable and engagement with treatment was high. Improvements with both interventions were observed. The beneficial effects on depression with CBT appeared to be sustained. Copyright © 2011 John Wiley & Sons, Ltd.

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pon.1921

The ToT study: helping with Touch or Talk (ToT): a pilot randomised controlled trial to examine the clinical effectiveness of aromatherapy massage versus cognitive behaviour therapy for emotional distress in patients in cancer/palliative care.

Aromatherapy massage is used in cancer palliative care to improve quality of life but there is little evidence for its effectiveness. A large pragmatic multicentre randomized controlled trial was set up to examine the effectiveness of aromatherapy in improving psychological distress and quality of life in patients with cancer. This paper examines the challenges encountered in the design and execution of the study. The original design, i) focused on palliative care patients with advanced disease; ii) had both a no-intervention and a treatment control group (relaxation therapy); and iii) adopted 90% power for sample size calculations. A varied measurement strategy was employed. Recruitment proved difficult, referrers were 'gate-keeping', patients were often too ill to approach and others declined. The trial was modified to ensure viability. Eligibility was extended to all patients with cancer irrespective of stage, the relaxation group was removed and the power reduced to 80%. Although it is not generally good practice to change a study design once recruitment has started, the changes were consistent with the original basic study aims and design principles. The data collection phase was successfully completed in July 2002.

Learning the hard way! Setting up an RCT of aromatherapy massage for patients with advanced cancer

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Learning the hard way! Setting up an RCT of aromatherapy massage for patients with advanced cancer