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.

Pelargonium sidoides root extract for the treatment of acute cough due to lower respiratory tract infection in adults: a feasibility double-blind, placebo-controlled randomised trial.

BACKGROUND: Pelargonium sidoides DC (Geraniaceae) root extract, EPs®7630 or "Kaloba®", is a widely used herbal remedy for respiratory infections, with some evidence of effectiveness for acute bronchitis. However, it is not yet widely recommended by medical professionals in the UK. There is a need to undertake appropriately designed randomised trials to test its use as an alternative to antibiotics. The aim was to assess the feasibility of conducting a double-blind randomised controlled trial of Pelargonium sidoides root extract for treatment of acute bronchitis in UK primary care, investigating intervention compliance, patient preference for dosage form and acceptability of patient diaries. STUDY DESIGN: Feasibility double-blind randomised placebo-controlled clinical trial. METHODS: We aimed to recruit 160 patients with cough (≤ 21 days) caused by acute bronchitis from UK general practices. Practices were cluster-randomised to liquid or tablet preparations and patients were individually randomised to Kaloba® or placebo. We followed participants up for 28 days through self-reported patient diaries with telephone support and reviewed medical records at one month. Outcomes included recruitment, withdrawal, safety, reconsultation and symptom diary completion rates. We also assessed treatment adherence, antibiotic prescribing and consumption, mean symptom severity (at days 2-4 after randomisation) and time to symptom resolution. We interviewed 29 patients and 11 health professionals to identify barriers and facilitators to running such a randomised trial. RESULTS: Of 543 patients screened, 261 were eligible, of whom 134 (51%) were recruited and 103 (77%) returned a completed diary. Overall, 41% (41/100) of patients took antibiotics (Kaloba® liquid group: 48% [15/31]; placebo liquid group: 23% [6/26]; Kaloba® tablet group: 48% [9/21]; placebo tablet group: 50% [11/22]). Most patients adhered to the study medication (median 19 out of 21 doses taken in week 1, IQR 18-21 - all arms combined). There were no serious adverse events relating to treatment. Most patients interviewed found study recruitment to be straightforward, but some found the diary too complex. CONCLUSIONS: It was feasible and acceptable to recruit patients from UK primary care to a double-blind placebo-controlled trial of herbal medicine (Kaloba®) for the treatment of acute bronchitis, with good retention and low data attrition. TRIAL REGISTRATION: HATRIC was registered on the ISRCTN registry ( ISRCTN17672884 ) on 16 August 2018, retrospectively registered. The record can be found at http://www.isrctn.com/ISRCTN17672884 .

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.

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

OBJECTIVE: To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain. DESIGN: Factorial randomised trial. Setting 64 general practices in England. PARTICIPANTS: 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons, and 144 to 24 Alexander technique lessons; half of each of these groups were randomised to exercise prescription. INTERVENTIONS: Normal care (control), six sessions of massage, six or 24 lessons on the Alexander technique, and prescription for exercise from a doctor with nurse delivered behavioural counselling. MAIN OUTCOME MEASURES: Roland Morris disability score (number of activities impaired by pain) and number of days in pain. RESULTS: Exercise and lessons in the Alexander technique, but not massage, remained effective at one year (compared with control Roland disability score 8.1: massage -0.58, 95% confidence interval -1.94 to 0.77, six lessons -1.40, -2.77 to -0.03, 24 lessons -3.4, -4.76 to -2.03, and exercise -1.29, -2.25 to -0.34). Exercise after six lessons achieved 72% of the effect of 24 lessons alone (Roland disability score -2.98 and -4.14, respectively). Number of days with back pain in the past four weeks were lower after lessons (compared with control median 21 days: 24 lessons -18, six lessons -10, massage -7) and quality of life improved significantly. No significant harms were reported. CONCLUSIONS: One to one lessons in the Alexander technique from registered teachers have long term benefits for patients with chronic back pain. Six lessons followed by exercise prescription were nearly as effective as 24 lessons.

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

OBJECTIVE: To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain. DESIGN: Factorial randomised trial. SETTING: 64 general practices in England. PARTICIPANTS: 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons, and 144 to 24 Alexander technique lessons; half of each of these groups were randomised to exercise prescription. INTERVENTIONS: Normal care (control), six sessions of massage, six or 24 lessons on the Alexander technique, and prescription for exercise from a doctor with nurse delivered behavioural counselling. MAIN OUTCOME MEASURES: Roland Morris disability score (number of activities impaired by pain) and number of days in pain. RESULTS: Exercise and lessons in the Alexander technique, but not massage, remained effective at one year (compared with control Roland disability score 8.1: massage -0.58, 95% confidence interval -1.94 to 0.77, six lessons -1.40, -2.77 to -0.03, 24 lessons -3.4, -4.76 to -2.03, and exercise -1.29, -2.25 to -0.34). Exercise after six lessons achieved 72% of the effect of 24 lessons alone (Roland disability score -2.98 and -4.14, respectively). Number of days with back pain in the past four weeks was lower after lessons (compared with control median 21 days: 24 lessons -18, six lessons -10, massage -7) and quality of life improved significantly. No significant harms were reported. CONCLUSIONS: One to one lessons in the Alexander technique from registered teachers have long term benefits for patients with chronic back pain. Six lessons followed by exercise prescription were nearly as effective as 24 lessons. TRIAL REGISTRATION: National Research Register N0028108728.