The feasibility and acceptability of trial procedures for a pragmatic randomised controlled trial of a structured physical activity intervention for people diagnosed with colorectal cancer: findings from a pilot trial of cardiac rehabilitation versus usual care (no rehabilitation) with an embedded qualitative study.

摘要: Pilot and feasibility work is conducted to evaluate the operational acceptability of intervention itself a trials’ protocol design. The Cardiac Rehabilitation In Bowel cancer (CRIB) study was pilot randomised controlled trial (RCT) cardiac rehabilitation versus usual care (no rehabilitation) for post-surgical colorectal patients. A key aim test RCT with embedded qualitative in three sites. Participants were randomly allocated or groups. Outcomes used assess parameters screening, eligibility, consent, randomisation, adverse events, retention, completion, missing data, adherence rates. Colorectal patients’ clinicians’ perceptions experiences main procedures explored by interview. Quantitative study. Three sites involved. Screening, retention rates 79 % (156/198), 67 % (133/198), 31 % (41/133), 93 % (38/41), respectively. Questionnaire completion 97.5 % (40/41), 75 % (31/41), 61 % (25/41) at baseline, follow-up 1, 2, Sixty-nine percent (40) accelerometer datasets collected from participants; (20) removed not meeting wear-time validation. Qualitative study: Thirty-eight patients eight clinicians participated. Key themes benefits people attending rehabilitation, barriers generic disease-specific concerns about including involvement rehabilitation. highlights where threats internal external validity are likely arise any future studies similar structured physical activity interventions using methods being contexts. This shows that there be potential recruitment bias imprecision due sub-optimal outcome measures, adherence. Hence, strategies manage these risks should developed stack odds favour conducting successful trials. ISRCTN63510637