A feasibility randomized controlled trial of a guided workbook intervention to support work-related goals among cancer survivors in the UK

Elizabeth Grunfeld, Lauren Schumacher, Maria Armaou, Pernille Woods, Pauline Rolf, Andrew Sutton, Anjali Zarkar, Steven Sadhra

Research output: Contribution to journalArticle

Abstract

Objectives: Employment following illness is associated with better physical and psychological functioning. This study aimed to assess the feasibility and acceptability of a theoretically-led workbook intervention designed to support cancer patients returning to work.
Design: Parallel-group randomized controlled trial with embedded qualitative interviews
Setting: Oncology clinics within four English National Health Service Trusts
Participants: Patients who had received a diagnosis of breast, gynecological, prostate or colorectal cancer and who were at least 2 weeks post-treatment initiation.
Intervention: A self-guided WorkPlan workbook designed to support cancer patients to return to work with fortnightly telephone support calls to discuss progress. The control group received treatment as usual, and were offered the workbook at the end of their 12-month follow-up.
Outcome measures: We assessed aspects of feasibility including eligibility, recruitment, data collection, attrition, feasibility of the methodology, acceptability of the intervention and potential to calculate cost-effectiveness.
Results: The recruitment rate of eligible patients was 44%; 68 participants consented and 58 (85%) completed baseline measures. Randomization procedures were acceptable, data collection methods (including cost-effectiveness data) were feasible and the intervention was acceptable to participants. Retention rates at six and 12 months follow-up were 72% and 69% respectively. At 6-month followup 30% of the usual care group had returned to full or part-time work (including phased return t work) compared to 43% of the intervention group. At 12-months the percentages were 47% (usual care) and 68% (intervention).
Conclusions: The findings confirm the feasibility of a definitive trial, although further consideration needs to be given to increasing the participation rates among men and Black and ethnic minority patients diagnosed with cancer.
Trial registration: International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN56342476
Strengths and limitations of this study
• The study assessed the feasibility and acceptability of a randomized controlled trial (RCT) of a theory-led intervention to support return to work among patients with a diagnosis of breast, gynecological, colorectal or prostate cancer.
• The intervention used a workbook format comprising of paper-based exercises and the development of a return to work plan.
• A mixed method design, with nested qualitative interviews, was used to assess the acceptability of the intervention, the feasibility of the RCT and to determine the utility of the patient reported outcome measures (PROMS).
• Only four cancer types were included, which may limit generalizability.
• Views of male participants, as well as Black and ethnic minority participants, were under represented, as the majority of participants were female and Caucasian and all were English speaking.
LanguageEnglish
Article numbere022746
JournalBMJ Open
Volume9
DOIs
Publication statusPublished - 21 Jan 2019

Fingerprint

Survivors
Randomized Controlled Trials
Return to Work
Neoplasms
Cost-Benefit Analysis
Colorectal Neoplasms
Prostatic Neoplasms
Breast Neoplasms
National Health Programs
Feasibility Studies
Random Allocation
Telephone
Outcome Assessment (Health Care)
Interviews
Exercise
Psychology
Control Groups
Therapeutics

Bibliographical note

© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ.
This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

Cite this

A feasibility randomized controlled trial of a guided workbook intervention to support work-related goals among cancer survivors in the UK. / Grunfeld, Elizabeth; Schumacher, Lauren; Armaou, Maria; Woods, Pernille; Rolf, Pauline; Sutton, Andrew; Zarkar, Anjali; Sadhra, Steven.

In: BMJ Open, Vol. 9, e022746, 21.01.2019.

Research output: Contribution to journalArticle

Grunfeld, Elizabeth ; Schumacher, Lauren ; Armaou, Maria ; Woods, Pernille ; Rolf, Pauline ; Sutton, Andrew ; Zarkar, Anjali ; Sadhra, Steven. / A feasibility randomized controlled trial of a guided workbook intervention to support work-related goals among cancer survivors in the UK. In: BMJ Open. 2019 ; Vol. 9.
@article{93155bb3abb24326a83d1ede1075d485,
title = "A feasibility randomized controlled trial of a guided workbook intervention to support work-related goals among cancer survivors in the UK",
abstract = "Objectives: Employment following illness is associated with better physical and psychological functioning. This study aimed to assess the feasibility and acceptability of a theoretically-led workbook intervention designed to support cancer patients returning to work.Design: Parallel-group randomized controlled trial with embedded qualitative interviewsSetting: Oncology clinics within four English National Health Service TrustsParticipants: Patients who had received a diagnosis of breast, gynecological, prostate or colorectal cancer and who were at least 2 weeks post-treatment initiation.Intervention: A self-guided WorkPlan workbook designed to support cancer patients to return to work with fortnightly telephone support calls to discuss progress. The control group received treatment as usual, and were offered the workbook at the end of their 12-month follow-up.Outcome measures: We assessed aspects of feasibility including eligibility, recruitment, data collection, attrition, feasibility of the methodology, acceptability of the intervention and potential to calculate cost-effectiveness.Results: The recruitment rate of eligible patients was 44{\%}; 68 participants consented and 58 (85{\%}) completed baseline measures. Randomization procedures were acceptable, data collection methods (including cost-effectiveness data) were feasible and the intervention was acceptable to participants. Retention rates at six and 12 months follow-up were 72{\%} and 69{\%} respectively. At 6-month followup 30{\%} of the usual care group had returned to full or part-time work (including phased return t work) compared to 43{\%} of the intervention group. At 12-months the percentages were 47{\%} (usual care) and 68{\%} (intervention).Conclusions: The findings confirm the feasibility of a definitive trial, although further consideration needs to be given to increasing the participation rates among men and Black and ethnic minority patients diagnosed with cancer.Trial registration: International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN56342476Strengths and limitations of this study• The study assessed the feasibility and acceptability of a randomized controlled trial (RCT) of a theory-led intervention to support return to work among patients with a diagnosis of breast, gynecological, colorectal or prostate cancer.• The intervention used a workbook format comprising of paper-based exercises and the development of a return to work plan.• A mixed method design, with nested qualitative interviews, was used to assess the acceptability of the intervention, the feasibility of the RCT and to determine the utility of the patient reported outcome measures (PROMS).• Only four cancer types were included, which may limit generalizability.• Views of male participants, as well as Black and ethnic minority participants, were under represented, as the majority of participants were female and Caucasian and all were English speaking.",
author = "Elizabeth Grunfeld and Lauren Schumacher and Maria Armaou and Pernille Woods and Pauline Rolf and Andrew Sutton and Anjali Zarkar and Steven Sadhra",
note = "{\circledC} Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.",
year = "2019",
month = "1",
day = "21",
doi = "10.1136/bmjopen-2018-022746",
language = "English",
volume = "9",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",

}

TY - JOUR

T1 - A feasibility randomized controlled trial of a guided workbook intervention to support work-related goals among cancer survivors in the UK

AU - Grunfeld, Elizabeth

AU - Schumacher, Lauren

AU - Armaou, Maria

AU - Woods, Pernille

AU - Rolf, Pauline

AU - Sutton, Andrew

AU - Zarkar, Anjali

AU - Sadhra, Steven

N1 - © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

PY - 2019/1/21

Y1 - 2019/1/21

N2 - Objectives: Employment following illness is associated with better physical and psychological functioning. This study aimed to assess the feasibility and acceptability of a theoretically-led workbook intervention designed to support cancer patients returning to work.Design: Parallel-group randomized controlled trial with embedded qualitative interviewsSetting: Oncology clinics within four English National Health Service TrustsParticipants: Patients who had received a diagnosis of breast, gynecological, prostate or colorectal cancer and who were at least 2 weeks post-treatment initiation.Intervention: A self-guided WorkPlan workbook designed to support cancer patients to return to work with fortnightly telephone support calls to discuss progress. The control group received treatment as usual, and were offered the workbook at the end of their 12-month follow-up.Outcome measures: We assessed aspects of feasibility including eligibility, recruitment, data collection, attrition, feasibility of the methodology, acceptability of the intervention and potential to calculate cost-effectiveness.Results: The recruitment rate of eligible patients was 44%; 68 participants consented and 58 (85%) completed baseline measures. Randomization procedures were acceptable, data collection methods (including cost-effectiveness data) were feasible and the intervention was acceptable to participants. Retention rates at six and 12 months follow-up were 72% and 69% respectively. At 6-month followup 30% of the usual care group had returned to full or part-time work (including phased return t work) compared to 43% of the intervention group. At 12-months the percentages were 47% (usual care) and 68% (intervention).Conclusions: The findings confirm the feasibility of a definitive trial, although further consideration needs to be given to increasing the participation rates among men and Black and ethnic minority patients diagnosed with cancer.Trial registration: International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN56342476Strengths and limitations of this study• The study assessed the feasibility and acceptability of a randomized controlled trial (RCT) of a theory-led intervention to support return to work among patients with a diagnosis of breast, gynecological, colorectal or prostate cancer.• The intervention used a workbook format comprising of paper-based exercises and the development of a return to work plan.• A mixed method design, with nested qualitative interviews, was used to assess the acceptability of the intervention, the feasibility of the RCT and to determine the utility of the patient reported outcome measures (PROMS).• Only four cancer types were included, which may limit generalizability.• Views of male participants, as well as Black and ethnic minority participants, were under represented, as the majority of participants were female and Caucasian and all were English speaking.

AB - Objectives: Employment following illness is associated with better physical and psychological functioning. This study aimed to assess the feasibility and acceptability of a theoretically-led workbook intervention designed to support cancer patients returning to work.Design: Parallel-group randomized controlled trial with embedded qualitative interviewsSetting: Oncology clinics within four English National Health Service TrustsParticipants: Patients who had received a diagnosis of breast, gynecological, prostate or colorectal cancer and who were at least 2 weeks post-treatment initiation.Intervention: A self-guided WorkPlan workbook designed to support cancer patients to return to work with fortnightly telephone support calls to discuss progress. The control group received treatment as usual, and were offered the workbook at the end of their 12-month follow-up.Outcome measures: We assessed aspects of feasibility including eligibility, recruitment, data collection, attrition, feasibility of the methodology, acceptability of the intervention and potential to calculate cost-effectiveness.Results: The recruitment rate of eligible patients was 44%; 68 participants consented and 58 (85%) completed baseline measures. Randomization procedures were acceptable, data collection methods (including cost-effectiveness data) were feasible and the intervention was acceptable to participants. Retention rates at six and 12 months follow-up were 72% and 69% respectively. At 6-month followup 30% of the usual care group had returned to full or part-time work (including phased return t work) compared to 43% of the intervention group. At 12-months the percentages were 47% (usual care) and 68% (intervention).Conclusions: The findings confirm the feasibility of a definitive trial, although further consideration needs to be given to increasing the participation rates among men and Black and ethnic minority patients diagnosed with cancer.Trial registration: International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN56342476Strengths and limitations of this study• The study assessed the feasibility and acceptability of a randomized controlled trial (RCT) of a theory-led intervention to support return to work among patients with a diagnosis of breast, gynecological, colorectal or prostate cancer.• The intervention used a workbook format comprising of paper-based exercises and the development of a return to work plan.• A mixed method design, with nested qualitative interviews, was used to assess the acceptability of the intervention, the feasibility of the RCT and to determine the utility of the patient reported outcome measures (PROMS).• Only four cancer types were included, which may limit generalizability.• Views of male participants, as well as Black and ethnic minority participants, were under represented, as the majority of participants were female and Caucasian and all were English speaking.

U2 - 10.1136/bmjopen-2018-022746

DO - 10.1136/bmjopen-2018-022746

M3 - Article

VL - 9

JO - BMJ Open

T2 - BMJ Open

JF - BMJ Open

SN - 2044-6055

M1 - e022746

ER -