Testing the Effectiveness of a Work Rehabilitation Intervention for Women with Breast Cancer

NCT06723899 | Recruiting

• 1 other identifier: TRI-CFR 23-06
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 2

Brief Summary

Women with breast cancer make up a significant proportion of cancer survivors, with more than 43,750 women living with breast cancer in Ireland. However, many women report physical and psychological health difficulties that interfere with their ability to return to work. In Ireland, and internationally, these difficulties are being increasingly recognised, with recent research identifying gaps in rehabilitation services to prepare women with breast cancer to return to work. Collaborating with women with breast cancer, and those who provide health and supportive services to individuals living with cancer in Ireland, an online self-management intervention, CanWork, was developed. CanWork aims to support women with breast cancer to manage the process of returning to work and learn strategies to manage post-treatment health-related difficulties. CanWork also provides information on workplace entitlements. This intervention was trialled with women with breast cancer in 2021, who reported that the programme gave them confidence to return to work and that the content was relevant. This study will include a larger group of women with breast cancer to determine if CanWork is effective in supporting return to work. To do this, 248 women with breast cancer will be included in the study, half of whom will receive CanWork and the results will be compared with women who do not receive the intervention. Having a programme that is financially viable is important and therefore the costs involved in running and attending the intervention will also be calculated. Should this study demonstrate that CanWork is effective in supporting women with breast cancer to return to work, the study team will collaborate with cancer services in Ireland to make the programme available nationally.

Conditions

Breast Cancer

Keywords

Breast cancer; Self-Management intervention; Occupational Therapy; Self-Efficacy; Return to work; Symptom management

Outcome Measures

Primary Outcomes (2)

• Return to work: Yes/No.

  The primary outcomes measure used in the feasibility study of CanWork was a self-report binary question of "Return to Work (RTW): Yes/No. This measure was identified in a systematic review as the most commonly used work-related measure in the included studies. RTW refers to any work resumption irrespective of number of hours a participant worked before their diagnosis. Participants will be asked immediately post-intervention, at three, six and 12-month follow-up periods if they have returned to work, on what date they returned and number of hours/week currently working

  From enrolment to 12-months following enrolment

• Return to Work Self-efficacy (RTW-SE) questionnaire

  The RTW-SE measure is a short ten-item questionnaire that asks participants to rate their level of confidence on a Likert scale of 1-10 to manage physical, psychological and emotional demands of work. Recent research has found that both the baseline RTW-SE score and subsequent increases in the RTW-SE score during return-to-work interventions are robust predictors of return to work.

  From enrolment to 12-months following enrolment

Secondary Outcomes (4)

• Readiness to return to work

  From enrolment to 12-months following enrolment

• Return to Work log book

  From enrolment to 12-months following enrolment

• EORTC QLQ-30

  From enrolment to 12-months following enrolment

• PROMIS Self-Efficacy for Managing Symptoms

  From enrolment to 12-months following enrolment

Other Outcomes (1)

• ICECAP-A (ICEpop CAPability measure for Adults)

  From study enrolment to 12-months following enrolment

Study Arms (2)

Intervention arm

EXPERIMENTAL

The intervention arm will receive an online occupational therapy intervention, CanWork, to increase knowledge and skills of women with breast cancer to manage cancer-related symptoms that interfere with return to work. It consists of five, 90-minute group-based modules and an individual meeting between the occupational therapist facilitator and each participant. Each of the group-based modules consists of two components. The first component focuses on education and peer-led discussion of cancer-related symptom management and supports available to manage difficulties in work. Topics covered each week include managing fatigue in work, understanding cancer-related cognitive impairments, strategies for managing physical and mental health in work and effective communication with employers and colleagues.

Other: CanWork

Comparator group

NO INTERVENTION

This group will act as a comparison group to the intervention arm. Study participants (women with breast cancer) in this group will not receive the CanWork intervention but will receive standard supportive care provided in their local community cancer support centre

Interventions

CanWork OTHER

CanWork is an online, occupational therapy intervention to develop knowledge and skills to manage cancer-related symptoms that interfere with return to work. It consists of five, 90-minute group-based modules and an individual meeting between the occupational therapist facilitator and each participant. Each of the five-week group-based modules consists of two components: (i) education and peer-led discussion of cancer-related symptom management and supports available to manage difficulties in work and (ii) goal setting to facilitate application of knowledge and skills to work-related activities. Weekly topics include managing fatigue in work, understanding cancer-related cognitive impairments, strategies for managing physical and mental health in work and effective communication with employers and colleagues. The individual meeting between each participant and the occupational therapist is focused on designing a tailored return to work plan for each participant.

Intervention arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with confirmed diagnosis of breast cancer
• Women with breast cancer who were in paid employment prior to their cancer diagnosis
• Women with breast cancer who have completed adjuvant oncology treatment (excluding hormone therapy, targeted and biological therapies) within the last 12 months
• Women with breast cancer who have capacity to participate in a six-week online occupational therapy intervention

You may not qualify if:

• Women with metastatic breast cancer
• Women with breast cancer who were not in paid employment prior to their cancer diagnosis
• Women with breast cancer who have decided not to return to work following completion of cancer treatment
• Women with breast cancer who have co-morbidity that would interfere with capacity to participate in a six-week online occupational therapy intervention

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• National Cancer Control Programme, Ireland: collaborator
• Royal College of Surgeons, Ireland: collaborator
• University of Galway: collaborator

Study Sites (2)

Cancer Care West

Galway, Ireland

RECRUITING

Solas Cancer Support Centre

Waterford, Ireland

RECRUITING

Related Publications (1)

• 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. 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. Contemp Clin Trials. 2025 Dec 15;161:108185. doi: 10.1016/j.cct.2025.108185. Online ahead of print.

  PMID: 41407101 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Deirdre Connolly, PhD

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deirdre Connolly, PhD

CONTACT

018963216; connoldm@tcd.ie

Nickola Pallin, PhD

CONTACT

018963216; palinn@tcd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Occupational Therapy

Model Details: This study is a cluster randomised control trial. One group will receive the intervention and the other group will receive standard care

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: November 13, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (2)