Examining the Effectiveness, and Cost-effectiveness, of CanWork, a Self-management Intervention to Support Women with Breast Cancer to Return to Work
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 248
- Locations
- 2
- Primary Endpoint
- Return to work: Yes/No.
Study Overview
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.
Detailed Description
The importance of supporting return to work (RTW) following a cancer diagnosis is increasingly recognised nationally and internationally. Other countries including the United Kingdom, Canada, and the United States, have also identified the importance of addressing work outcomes for those living with and beyond cancer. The goal for many cancer survivors is to optimise quality of life, including return to work. A recent report by the European Commission recommended that assessment and interventions for enhancing return to work for those with cancer should be integral parts of the survivorship pathway. As survivor numbers continue to increase the economic benefit of individuals returning to work will be considerable.
Breast cancer is now the most common cancer worldwide. In Ireland, the National Cancer Strategy (2017-2026) identified that 23% of all cancer survivors are comprised of women with breast cancer. The impact of disease and treatment-related side effects on work ability of women with breast cancer include cancer-related fatigue, pain, reduced cognitive function, anxiety, and depression. Therefore research is recommended for the development and evaluation of interventions to support women living with and beyond breast cancer to return to, and manage cancer related symptoms at, work.
CanWork is an online, occupational therapy self-management intervention that was designed in collaboration with women with breast cancer, healthcare professionals, cancer service providers and Health Service Executive staff with responsibility for development and delivery of cancer services in Ireland. Self-efficacy is the underlying theory of self-management interventions. Self-efficacy is the belief individuals have in their ability to change and take the necessary actions to make those changes. Perceived self-efficacy forms the basis of any decision to act and is defined as the perception of one's own ability to implement behaviours to attain designated types of outcomes such as improved health and well-being.
The primary aim of CanWork is to facilitate development of knowledge and skills to manage cancer-related symptoms that interfere with return to work. It consists of five, 90-minute group-based meetings and a once-off single individual meeting between the occupational therapist facilitator and each participant. Each of the group-based sessions 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. The 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.
Feasibility testing of CanWork demonstrated strong uptake for, and acceptability of, the intervention. The aim of this study, therefore, is to test the effectiveness of the CanWork intervention in facilitating women with breast cancer to return to work.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Intervention arm
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.
Intervention: CanWork (Other)
Comparator group
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
Outcomes
Primary Outcomes
Return to work: Yes/No.
Time Frame: From enrolment to 12-months following enrolment
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
Return to Work Self-efficacy (RTW-SE) questionnaire
Time Frame: From enrolment to 12-months following enrolment
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.
Secondary Outcomes
- 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)
Investigators
Deirdre Connolly
Professor in Occupational Therapy
University of Dublin, Trinity College