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

Gill Hubbard, Ronan O'Carroll, Julie Munro, Nanette Mutrie, Sally Haw, Helen Mason, Shaun Treweek

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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.
Original languageEnglish
Article number51
Pages (from-to)1-15
Number of pages15
JournalPilot & Feasibility Studies
Volume2
DOIs
Publication statusPublished - 24 Aug 2016

Fingerprint

Colorectal Neoplasms
Rehabilitation
Randomized Controlled Trials
Exercise
Clinical Protocols
Random Allocation
Cardiac Rehabilitation
Colonic Neoplasms
Outcome Assessment (Health Care)
Interviews
Neoplasms

Keywords

  • pilot
  • feasibility
  • acceptability
  • cardiac rehabilitation
  • colorectal cancer
  • physical activity

Cite this

@article{c49b4cd6cafc4b51b55db37471536618,
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 = "BackgroundPilot 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.MethodsA 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.ResultsQuantitative 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.ConclusionsThe 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.",
keywords = "pilot, feasibility, acceptability, cardiac rehabilitation, colorectal cancer, physical activity",
author = "Gill Hubbard and Ronan O'Carroll and Julie Munro and Nanette Mutrie and Sally Haw and Helen Mason and Shaun Treweek",
note = "Acknowledgements The authors would like to sincerely thank the participants who gave up their time to take part in this study. We would also like to thank the research assistants on all sites for their hard work for the duration of the study. Our thanks also go out to the clinical staff in both colorectal and cardiac rehabilitation services on all three sites; without your support, this work could not go ahead. Finally, we wish to acknowledge the contribution of other members of the research team: Lisa Kidd, Richard Adams, Angus JM Watson Stephen J Leslie, Petra Rauchhaus, Anna Campbell, Sarkis Manoukian, and Gillian Sweetman. All authors read and approved the final manuscript. Funding This work is supported by the National Institute for Health Research—Health Service and Development Research, Project reference number: NIHR—HS&DR Project:12/5001/09.",
year = "2016",
month = "8",
day = "24",
doi = "10.1186/s40814-016-0090-y",
language = "English",
volume = "2",
pages = "1--15",
journal = "Pilot & Feasibility Studies",
issn = "2055-5784",
publisher = "BioMed Central",

}

TY - JOUR

T1 - 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

T2 - findings from a pilot trial of cardiac rehabilitation versus usual care (no rehabilitation) with an embedded qualitative study

AU - Hubbard, Gill

AU - O'Carroll, Ronan

AU - Munro, Julie

AU - Mutrie, Nanette

AU - Haw, Sally

AU - Mason, Helen

AU - Treweek, Shaun

N1 - Acknowledgements The authors would like to sincerely thank the participants who gave up their time to take part in this study. We would also like to thank the research assistants on all sites for their hard work for the duration of the study. Our thanks also go out to the clinical staff in both colorectal and cardiac rehabilitation services on all three sites; without your support, this work could not go ahead. Finally, we wish to acknowledge the contribution of other members of the research team: Lisa Kidd, Richard Adams, Angus JM Watson Stephen J Leslie, Petra Rauchhaus, Anna Campbell, Sarkis Manoukian, and Gillian Sweetman. All authors read and approved the final manuscript. Funding This work is supported by the National Institute for Health Research—Health Service and Development Research, Project reference number: NIHR—HS&DR Project:12/5001/09.

PY - 2016/8/24

Y1 - 2016/8/24

N2 - BackgroundPilot 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.MethodsA 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.ResultsQuantitative 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.ConclusionsThe 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.

AB - BackgroundPilot 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.MethodsA 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.ResultsQuantitative 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.ConclusionsThe 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.

KW - pilot

KW - feasibility

KW - acceptability

KW - cardiac rehabilitation

KW - colorectal cancer

KW - physical activity

U2 - 10.1186/s40814-016-0090-y

DO - 10.1186/s40814-016-0090-y

M3 - Article

VL - 2

SP - 1

EP - 15

JO - Pilot & Feasibility Studies

JF - Pilot & Feasibility Studies

SN - 2055-5784

M1 - 51

ER -