A cluster randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management intervention to support women with breast cancer to return to work: A study protocol

Nickola D Pallin; Naomi Algeo; Mary Eileen O'Connor; Hayley Connolly; Michelle Lowry; Kathleen Bennett; Patrick Gillespie; Anna Hobbins; Pamela Gallagher; Louise Mullen; Kathleen D Lyons; Sheena M McHugh; Deirdre Connolly

doi:10.1016/j.cct.2025.108185

A cluster randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management intervention to support women with breast cancer to return to work: A study protocol

Nickola D Pallin
, Naomi Algeo
, Mary Eileen O'Connor
, Hayley Connolly
, Michelle Lowry
, Kathleen Bennett
, Patrick Gillespie
, Anna Hobbins
, Pamela Gallagher
, Louise Mullen
, Kathleen D Lyons
, Sheena M McHugh
, Deirdre Connolly

Trinity College Dublin
RCSI University of Medicine and Health Sciences
J.E. Cairnes School of Business and Economics and the Institute for Lifecourse and Society
CÚRAM- Research Ireland Centre for Medical Devices
Institute for Lifecourse and Society (ILAS)
Dublin City University
National Cancer Control Programme
MGH Institute of Health Professions
University College Cork

Research output: Contribution to a Journal (Peer & Non Peer) › Article › peer-review

Abstract

INTRODUCTION: Women living with and beyond breast cancer (LWBBC) often experience challenges in returning to work (RTW) because of disease and treatment-related side effects. Therefore, interventions to enhance RTW for those LWBBC are a recommended component of cancer survivorship care. CanWork is a six-week, self-management support programme designed to facilitate women LWBBC in developing knowledge and skills to manage cancer-related symptoms that interfere with RTW. This paper presents the protocol for a cluster randomised controlled trial that will test the effectiveness and cost effectiveness of CanWork in supporting women LWBBC in RTW following completion of cancer treatment.

METHODS: A cluster-randomised controlled trial will be conducted through community cancer support centres in the Republic of Ireland. Centres will be assigned to the control or intervention arms by randomisation and the aim is to recruit 248 women. The two primary outcomes are changes in RTW (yes: returned to work; no: not returned to work) and self-efficacy to manage physical, psychological and emotional demands of work at 12 months follow up post-intervention. Secondary outcomes are readiness to return to work, self-efficacy for managing cancer-related symptoms that interfere with work, health related quality of life and absence from work for cancer-related reasons at 12 months follow up post-intervention. Cost effectiveness will also be measured. Follow-up will occur up to 12-months post-intervention using self-reported questionnaires.

DISCUSSION: Findings will determine whether CanWork is an effective and cost-effective intervention in supporting women with breast cancer to return to work.

TRIAL REGISTRATION NUMBER: NCT06723899.

Original language	English
Pages (from-to)	108185
Journal	Contemporary Clinical Trials
Volume	161
DOIs	https://doi.org/10.1016/j.cct.2025.108185
Publication status	Published - Feb 2026

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Humans
Female
Breast Neoplasms/psychology
Return to Work/psychology
Cost-Benefit Analysis
Self-Management/methods
Ireland
Self Efficacy
Cancer Survivors/psychology
Randomized Controlled Trials as Topic
Quality of Life
Adult

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10.1016/j.cct.2025.108185

Cite this

Pallin, N. D., Algeo, N., O'Connor, M. E., Connolly, H., Lowry, M., Bennett, K., Gillespie, P., Hobbins, A., Gallagher, P., Mullen, L., Lyons, K. D., McHugh, S. M., & Connolly, D. (2026). A cluster randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management intervention to support women with breast cancer to return to work: A study protocol. Contemporary Clinical Trials, 161, 108185. https://doi.org/10.1016/j.cct.2025.108185

@article{e936eb99d5e64f25af4f77050bca0244,

title = "A cluster randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management intervention to support women with breast cancer to return to work: A study protocol",

abstract = "INTRODUCTION: Women living with and beyond breast cancer (LWBBC) often experience challenges in returning to work (RTW) because of disease and treatment-related side effects. Therefore, interventions to enhance RTW for those LWBBC are a recommended component of cancer survivorship care. CanWork is a six-week, self-management support programme designed to facilitate women LWBBC in developing knowledge and skills to manage cancer-related symptoms that interfere with RTW. This paper presents the protocol for a cluster randomised controlled trial that will test the effectiveness and cost effectiveness of CanWork in supporting women LWBBC in RTW following completion of cancer treatment.METHODS: A cluster-randomised controlled trial will be conducted through community cancer support centres in the Republic of Ireland. Centres will be assigned to the control or intervention arms by randomisation and the aim is to recruit 248 women. The two primary outcomes are changes in RTW (yes: returned to work; no: not returned to work) and self-efficacy to manage physical, psychological and emotional demands of work at 12 months follow up post-intervention. Secondary outcomes are readiness to return to work, self-efficacy for managing cancer-related symptoms that interfere with work, health related quality of life and absence from work for cancer-related reasons at 12 months follow up post-intervention. Cost effectiveness will also be measured. Follow-up will occur up to 12-months post-intervention using self-reported questionnaires.DISCUSSION: Findings will determine whether CanWork is an effective and cost-effective intervention in supporting women with breast cancer to return to work.TRIAL REGISTRATION NUMBER: NCT06723899.",

keywords = "Humans, Female, Breast Neoplasms/psychology, Return to Work/psychology, Cost-Benefit Analysis, Self-Management/methods, Ireland, Self Efficacy, Cancer Survivors/psychology, Randomized Controlled Trials as Topic, Quality of Life, Adult",

author = "Pallin, \{Nickola D\} and Naomi Algeo and O'Connor, \{Mary Eileen\} and Hayley Connolly and Michelle Lowry and Kathleen Bennett and Patrick Gillespie and Anna Hobbins and Pamela Gallagher and Louise Mullen and Lyons, \{Kathleen D\} and McHugh, \{Sheena M\} and Deirdre Connolly",

year = "2026",

month = feb,

doi = "10.1016/j.cct.2025.108185",

language = "English",

volume = "161",

pages = "108185",

journal = "Contemporary Clinical Trials",

issn = "1551-7144",

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Pallin, ND, Algeo, N, O'Connor, ME, Connolly, H, Lowry, M, Bennett, K, Gillespie, P , Hobbins, A, Gallagher, P, Mullen, L, Lyons, KD, McHugh, SM & Connolly, D 2026, 'A cluster randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management intervention to support women with breast cancer to return to work: A study protocol', Contemporary Clinical Trials, vol. 161, pp. 108185. https://doi.org/10.1016/j.cct.2025.108185

A cluster randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management intervention to support women with breast cancer to return to work: A study protocol. / Pallin, Nickola D; Algeo, Naomi; O'Connor, Mary Eileen et al.
In: Contemporary Clinical Trials, Vol. 161, 02.2026, p. 108185.

Research output: Contribution to a Journal (Peer & Non Peer) › Article › peer-review

TY - JOUR

T1 - A cluster randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management intervention to support women with breast cancer to return to work

T2 - A study protocol

AU - Pallin, Nickola D

AU - Algeo, Naomi

AU - O'Connor, Mary Eileen

AU - Connolly, Hayley

AU - Lowry, Michelle

AU - Bennett, Kathleen

AU - Gillespie, Patrick

AU - Hobbins, Anna

AU - Gallagher, Pamela

AU - Mullen, Louise

AU - Lyons, Kathleen D

AU - McHugh, Sheena M

AU - Connolly, Deirdre

PY - 2026/2

Y1 - 2026/2

N2 - INTRODUCTION: Women living with and beyond breast cancer (LWBBC) often experience challenges in returning to work (RTW) because of disease and treatment-related side effects. Therefore, interventions to enhance RTW for those LWBBC are a recommended component of cancer survivorship care. CanWork is a six-week, self-management support programme designed to facilitate women LWBBC in developing knowledge and skills to manage cancer-related symptoms that interfere with RTW. This paper presents the protocol for a cluster randomised controlled trial that will test the effectiveness and cost effectiveness of CanWork in supporting women LWBBC in RTW following completion of cancer treatment.METHODS: A cluster-randomised controlled trial will be conducted through community cancer support centres in the Republic of Ireland. Centres will be assigned to the control or intervention arms by randomisation and the aim is to recruit 248 women. The two primary outcomes are changes in RTW (yes: returned to work; no: not returned to work) and self-efficacy to manage physical, psychological and emotional demands of work at 12 months follow up post-intervention. Secondary outcomes are readiness to return to work, self-efficacy for managing cancer-related symptoms that interfere with work, health related quality of life and absence from work for cancer-related reasons at 12 months follow up post-intervention. Cost effectiveness will also be measured. Follow-up will occur up to 12-months post-intervention using self-reported questionnaires.DISCUSSION: Findings will determine whether CanWork is an effective and cost-effective intervention in supporting women with breast cancer to return to work.TRIAL REGISTRATION NUMBER: NCT06723899.

AB - INTRODUCTION: Women living with and beyond breast cancer (LWBBC) often experience challenges in returning to work (RTW) because of disease and treatment-related side effects. Therefore, interventions to enhance RTW for those LWBBC are a recommended component of cancer survivorship care. CanWork is a six-week, self-management support programme designed to facilitate women LWBBC in developing knowledge and skills to manage cancer-related symptoms that interfere with RTW. This paper presents the protocol for a cluster randomised controlled trial that will test the effectiveness and cost effectiveness of CanWork in supporting women LWBBC in RTW following completion of cancer treatment.METHODS: A cluster-randomised controlled trial will be conducted through community cancer support centres in the Republic of Ireland. Centres will be assigned to the control or intervention arms by randomisation and the aim is to recruit 248 women. The two primary outcomes are changes in RTW (yes: returned to work; no: not returned to work) and self-efficacy to manage physical, psychological and emotional demands of work at 12 months follow up post-intervention. Secondary outcomes are readiness to return to work, self-efficacy for managing cancer-related symptoms that interfere with work, health related quality of life and absence from work for cancer-related reasons at 12 months follow up post-intervention. Cost effectiveness will also be measured. Follow-up will occur up to 12-months post-intervention using self-reported questionnaires.DISCUSSION: Findings will determine whether CanWork is an effective and cost-effective intervention in supporting women with breast cancer to return to work.TRIAL REGISTRATION NUMBER: NCT06723899.

KW - Humans

KW - Female

KW - Breast Neoplasms/psychology

KW - Return to Work/psychology

KW - Cost-Benefit Analysis

KW - Self-Management/methods

KW - Ireland

KW - Self Efficacy

KW - Cancer Survivors/psychology

KW - Randomized Controlled Trials as Topic

KW - Quality of Life

KW - Adult

U2 - 10.1016/j.cct.2025.108185

DO - 10.1016/j.cct.2025.108185

M3 - Article

C2 - 41407101

SN - 1551-7144

VL - 161

SP - 108185

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

ER -

A cluster randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management intervention to support women with breast cancer to return to work: A study protocol

Abstract

UN SDGs

Keywords

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