A randomised controlled trial of a digital intervention (Renewed) to support symptom management, wellbeing and quality of life in cancer survivors.

BACKGROUND: Many cancer survivors following primary treatment have prolonged poor quality of life. AIM: To determine the effectiveness of a bespoke digital intervention to support cancer survivors. DESIGN: Pragmatic parallel open randomised trial. SETTING: UK general practices. METHODS: People having finished primary treatment (<= 10 years previously) for colo-rectal, breast or prostate cancers, with European-Organization-for-Research-and-Treatment-of-Cancer QLQ-C30 score <85, were randomised by online software to: 1)detailed 'generic' digital NHS support ('LiveWell';n=906), 2) a bespoke complex digital intervention ('Renewed';n=903) addressing symptom management, physical activity, diet, weight loss, distress, or 3) 'Renewed-with-support' (n=903): 'Renewed' with additional brief email and telephone support. RESULTS: Mixed linear regression provided estimates of the differences between each intervention group and generic advice: at 6 months (primary time point: n's respectively 806;749;705) all groups improved, with no significant between-group differences for EORTC QLQ-C30, but global health improved more in both intervention groups. By 12 months there were: small improvements in EORTC QLQ-C30 for Renewed-with-support (versus generic advice: 1.42, 95% CIs 0.33-2.51); both groups improved global health (12 months: renewed: 3.06, 1.39-4.74; renewed-with-support: 2.78, 1.08-4.48), dyspnoea, constipation, and enablement, and lower NHS costs (generic advice £265: in comparison respectively £141 (153-128) and £77 (90-65) lower); and for Renewed-with-support improvement in several other symptom subscales. No harms were identified. CONCLUSION: Cancer survivors quality of life improved with detailed generic online support. Robustly developed bespoke digital support provides limited additional short term benefit, but additional longer term improvement in global health enablement and symptom management, with substantially lower NHS costs.

Renewed: Protocol for a randomised controlled trial of a digital intervention to support quality of life in cancer survivors.

INTRODUCTION: Low quality of life is common in cancer survivors. Increasing physical activity, improving diet, supporting psychological well-being and weight loss can improve quality of life in several cancers and may limit relapse. The aim of the randomised controlled trial outlined in this protocol is to examine whether a digital intervention (Renewed), with or without human support, can improve quality of life in cancer survivors. Renewed provides support for increasing physical activity, managing difficult emotions, eating a healthier diet and weight management. METHODS AND ANALYSIS: A randomised controlled trial is being conducted comparing usual care, access to Renewed or access to Renewed with brief human support. Cancer survivors who have had colorectal, breast or prostate cancer will be identified and invited through general practice searches and mail-outs. Participants are asked to complete baseline measures immediately after screening and will then be randomised to a study group; this is all completed on the Renewed website. The primary outcome is quality of life measured by the European Organization for Research and Treatment of Cancer QLQ-c30. Secondary outcomes include anxiety and depression, fear of cancer recurrence, general well-being, enablement and items relating to costs for a health economics analysis. Process measures include perceptions of human support, intervention usage and satisfaction, and adherence to behavioural changes. Qualitative process evaluations will be conducted with patients and healthcare staff providing support. ETHICS AND DISSEMINATION: The trial has been approved by the NHS Research Ethics Committee (Reference 18/NW/0013). The results of this trial will be published in peer-reviewed journals and through conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN96374224; Pre-results.

Patients' views of receiving lessons in the Alexander technique and an exercise prescription for managing back pain in the ATEAM trial.

BACKGROUND: Lessons in the Alexander Technique and exercise prescription proved effective for managing low back pain in primary care in a clinical trial. OBJECTIVES: To understand trial participants' expectations and experiences of the Alexander Technique and exercise prescription. METHODS: A questionnaire assessing attitudes to the intervention, based on the Theory of Planned Behaviour, was completed at baseline and 3-month follow-up by 183 people assigned to lessons in the Alexander Technique and 176 people assigned to exercise prescription. Semi-structured interviews to assess the beliefs contributing to attitudes to the intervention were carried out at baseline with14 people assigned to the lessons in the Alexander Technique and 16 to exercise prescription, and at follow-up with 15 members of the baseline sample. RESULTS: Questionnaire responses indicated that attitudes to both interventions were positive at baseline but became more positive at follow-up only in those assigned to lessons in the Alexander Technique. Thematic analysis of the interviews suggested that at follow-up many patients who had learned the Alexander Technique felt they could manage back pain better. Whereas many obstacles to exercising were reported, few barriers to learning the Alexander Technique were described, since it 'made sense', could be practiced while carrying out everyday activities or relaxing, and the teachers provided personal advice and support. CONCLUSION: Using the Alexander Technique was viewed as effective by most patients. Acceptability may have been superior to exercise because of a convincing rationale and social support and a better perceived fit with the patient's particular symptoms and lifestyle.

Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain: economic evaluation.

OBJECTIVE: An economic evaluation of therapeutic massage, exercise, and lessons in the Alexander technique for treating persistent back pain. DESIGN: Cost consequences study and cost effectiveness analysis at 12 month follow-up of a factorial randomised controlled trial. PARTICIPANTS: 579 patients with chronic or recurrent low back pain recruited from primary care. INTERVENTIONS: Normal care (control), massage, and six or 24 lessons in the Alexander technique. Half of each group were randomised to a prescription for exercise from a doctor plus behavioural counselling from a nurse. MAIN OUTCOME MEASURES: Costs to the NHS and to participants. Comparison of costs with Roland-Morris disability score (number of activities impaired by pain), days in pain, and quality adjusted life years (QALYs). Comparison of NHS costs with QALY gain, using incremental cost effectiveness ratios and cost effectiveness acceptability curves. RESULTS: Intervention costs ranged from pound30 for exercise prescription to pound596 for 24 lessons in Alexander technique plus exercise. Cost of health services ranged from pound50 for 24 lessons in Alexander technique to pound124 for exercise. Incremental cost effectiveness analysis of single therapies showed that exercise offered best value ( pound61 per point on disability score, pound9 per additional pain-free day, pound2847 per QALY gain). For two-stage therapy, six lessons in Alexander technique combined with exercise was the best value (additional pound64 per point on disability score, pound43 per additional pain-free day, pound5332 per QALY gain). CONCLUSIONS: An exercise prescription and six lessons in Alexander technique alone were both more than 85% likely to be cost effective at values above pound20 000 per QALY, but the Alexander technique performed better than exercise on the full range of outcomes. A combination of six lessons in Alexander technique lessons followed by exercise was the most effective and cost effective option.

Comparison of agreement between different measures of blood pressure in primary care and daytime ambulatory blood pressure.

OBJECTIVE: To assess alternatives to measuring ambulatory pressure, which best predicts response to treatment and adverse outcome. SETTING: Three general practices in England. DESIGN: Validation study. PARTICIPANTS: Patients with newly diagnosed high or borderline high blood pressure; patients receiving treatment for hypertension but with poor control. MAIN OUTCOME MEASURES: Overall agreement with ambulatory pressure; prediction of high ambulatory pressure (>135/85 mm Hg) and treatment thresholds. RESULTS: Readings made by doctors were much higher than ambulatory systolic pressure (difference 18.9 mm Hg, 95% confidence interval 16.1 to 21.7), as were recent readings made in the clinic outside research settings (19.9 mm Hg,17.6 to 22.1). This applied equally to treated patients with poor control (doctor v ambulatory 21.4 mm Hg, 17.3 to 25.4). Doctors' and recent clinic readings ranked systolic pressure poorly compared with ambulatory pressure and other measurements (doctor r=0.46; clinic 0.47; repeated readings by nurse 0.60; repeated self measurement 0.73; home readings 0.75) and were not specific at predicting high blood pressure (doctor 26%; recent clinic 15%; nurse 72%; patient in surgery 81%; home 60%), with poor likelihood ratios for a positive test (doctor 1.2; clinic 1.1; nurse 2.1, patient in surgery 4.7; home 2.2). Nor were doctor or recent clinic measures specific in predicting treatment thresholds. CONCLUSION: The "white coat" effect is important in diagnosing and assessing control of hypertension in primary care and is not a research artefact. If ambulatory or home measurements are not available, repeated measurements by the nurse or patient should result in considerably less unnecessary monitoring, initiation, or changing of treatment. It is time to stop using high blood pressure readings documented by general practitioners to make treatment decisions.