title: 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.
abstract: BACKGROUND
  Pilot and feasibility work is conducted to evaluate the operational feasibility and acceptability of the intervention itself and the feasibility and acceptability of a trials' protocol design. The Cardiac Rehabilitation In Bowel cancer (CRIB) study was a pilot randomised controlled trial (RCT) of cardiac rehabilitation versus usual care (no rehabilitation) for post-surgical colorectal cancer patients. A key aim of the pilot trial was to test the feasibility and acceptability of the protocol design.
  
  
  METHODS
  A pilot RCT with embedded qualitative work was conducted in three sites. Participants were randomly allocated to cardiac rehabilitation or usual care groups. Outcomes used to assess the feasibility and acceptability of key trial parameters were screening, eligibility, consent, randomisation, adverse events, retention, completion, missing data, and intervention adherence rates. Colorectal patients' and clinicians' perceptions and experiences of the main trial procedures were explored by interview.
  
  
  RESULTS
  Quantitative study. Three sites were involved. Screening, eligibility, consent, and retention rates were 79 % (156/198), 67 % (133/198), 31 % (41/133), and 93 % (38/41), respectively. Questionnaire completion rates were 97.5 % (40/41), 75 % (31/41), and 61 % (25/41) at baseline, follow-up 1, and follow-up 2, respectively. Sixty-nine percent (40) of accelerometer datasets were collected from participants; 31 % (20) were removed for not meeting wear-time validation. Qualitative study: Thirty-eight patients and eight clinicians participated. Key themes were benefits for people with colorectal cancer attending cardiac rehabilitation, barriers for people with colorectal cancer attending cardiac rehabilitation, generic versus disease-specific rehabilitation, key concerns about including people with cancer in cardiac rehabilitation, and barriers to involvement in a study about cardiac rehabilitation.
  
  
  CONCLUSIONS
  The study highlights where threats to internal and external validity are likely to arise in any future studies of similar structured physical activity interventions for colorectal cancer patients using similar methods being conducted in similar contexts. This study shows that there is likely to be potential recruitment bias and potential imprecision due to sub-optimal completion of outcome measures, missing data, and sub-optimal intervention adherence. Hence, strategies to manage these risks should be developed to stack the odds in favour of conducting successful future trials.
  
  
  BACKGROUND
  ISRCTN63510637.
authors.affiliation: School of Health Sciences, University of Stirling, Highland Campus, Old Perth Road, Inverness, IV2 3JH UK.
authors.forename: Gill
authors.initials: G
authors.lastname: Hubbard
authors.affiliation: Department of Psychology, University of Stirling, Stirling, FK9 4LA UK.
authors.forename: Ronan
authors.initials: R
authors.lastname: O'Carroll
authors.affiliation: Centre for Health Science, School of Health Science, University of Stirling, Highland Campus, Old Perth Road, Inverness, IV2 3JH UK.
authors.forename: Julie
authors.initials: J
authors.lastname: Munro
authors.affiliation: Moray House School of Education, Institute for Sport, Physical Education and Health Sciences, University of Edinburgh, Edinburgh, EH8 8AQ UK.
authors.forename: Nanette
authors.initials: N
authors.lastname: Mutrie
authors.affiliation: School of Health Science, University of Stirling, Stirling, FK9 4LA UK.
authors.forename: Sally
authors.initials: S
authors.lastname: Haw
authors.affiliation: Helen Mason, Yunus Centre in Social Business and Health, Glasgow Caledonian University, Glasgow, G4 0BA UK.
authors.forename: Helen
authors.initials: H
authors.lastname: Mason
authors.affiliation: Shaun Treweek, Health Services Research Unit, University of Aberdeen, Aberdeen, AB25 2ZD UK.
authors.forename: Shaun
authors.initials: S
authors.lastname: Treweek
keywords: Acceptability; Cardiac rehabilitation; Colorectal cancer; Feasibility; Physical activity; Pilot