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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorUniversity of Dublin, Trinity College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • CanWork

    Other intervention

    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.

Treatment groups

248 Participants
are divided into 2 treatment groups
Group A: Intervention armExperimental treatment 1 intervention
Group B: Comparator groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
From enrolment to 12-months following enrolment
2

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.

Time frame
From enrolment to 12-months following enrolment

Secondary outcomes

1

Readiness to return to work

Participants will rate their current perceived readiness to return to work on a 10-point Likert scale: 0 (not at all ready) to 10 (extremely ready).

Time frame
From enrolment to 12-months following enrolment
2

Return to Work log book

All participants (intervention and control group) who have returned to work will be required to keep a work-related logbook over a 12-month period following enrolment into the CanWork study. This logbook will record any absences (planned or unplanned) from work for cancer-related reasons. The following information will be collected: Dates of absenteeism Reason for absenteeism Date returned to work Total time absent from work

Time frame
From enrolment to 12-months following enrolment
3

EORTC QLQ-30

Health related quality of life will be measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) with the relevant subscale for breast cancer QLQ-BR23. The EORTC-QLQ-C30 includes 30 items embedded over nine scales: five functional scales (physical, role, cognitive, emotional, and social functioning), three symptom scales (fatigue, pain, nausea and vomiting), and a global health status quality of life scale. Six single-items assess financial difficulties and symptoms commonly reported by those living with and beyond cancer: dyspnoea, insomnia, appetite loss, constipation and diarrhoea. The QLQ-BR23 questionnaire comprises of 23-items and is categorised into functional scales and symptom scales. Functional scales include items on body image, sexual functioning, sexual enjoyment, and future perspective. Future perspective explores the extent to which a participant is worried about their health in the future.

Time frame
From enrolment to 12-months following enrolment
4

PROMIS Self-Efficacy for Managing Symptoms

The PROMIS Self-Efficacy for Managing Symptoms is an eight-item measure that examines participants' confidence in managing their symptoms in different settings (home, work and public places) and in preventing their symptoms from interfering with their personal activities, work and relationships. This measure has been calibrated across a number of different chronic diseases and demonstrates strong internal consistency and validity.

Time frame
From enrolment to 12-months following enrolment

Other outcomes

1

ICECAP-A (ICEpop CAPability measure for Adults)

ICECAP-A is designed to assess overall quality of life and well-being of adults. It focuses on broader life aspects rather than just health-related factors. The measure is based on the concept of capability, which considers what individuals are able to do in their lives, encompassing a range of attributes that contribute to a fulfilling life. ICECAP-A evaluates five key dimensions of capability: Stability Attachment, Autonomy, Achievement and Enjoyment. Respondents rate their level of capability in each dimension, providing a comprehensive picture of their overall well-being. The ICECAP-A total score will be converted to a utility score to assess cost effectiveness of CanWork.

Time frame
From study enrolment to 12-months following enrolment

Sponsors and contacts

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University of Dublin, Trinity College

Lead sponsor

National Cancer Control Programme, Ireland

Collaborator

Royal College of Surgeons, Ireland

Collaborator

University of Galway

Collaborator