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

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. Methods Study design A Cluster randomised trial (CRT) will be used to test the effectiveness of the CanWork intervention. The CRT will be carried out within the Medical Research Council (MRC) Framework for the development and evaluation of complex interventions to improve health outcomes for individuals with chronic health difficulties. The CONSORT guidelines extension for cluster randomised trials for the design and reporting of randomized controlled trials at all stages from recruitment of cancer centres (study clusters) and individual participants, randomisation, data collection, analysis and reporting will be used. (www.equator-network.org) The units of randomisation for this study are Community Cancer Support Centres. In Ireland Community Cancer Support Centres (CCSC) are recognised as an essential part of provision of support for individuals with cancer, their families and carers. They provide a range of services from the provision of information, psychological support and survivorship programmes, to complementary therapies, yoga, relaxation classes, support groups, financial advice and drop-in services. CCSC operate in the charity sector and mainly rely on fund-raising activities to fund delivery of their services but they also receive project-based governmental funding. Study sample The sample size required for this study is 248 women with breast cancer. This is based on detecting a 22% difference in return-to-work rates between the control and intervention clusters. Data collection This study will use two primary outcome measures: Return to work: Yes/No. Return to Work Self-efficacy (RTW-SE) questionnaire Secondary measures will examine readiness to return to work, self-efficacy for managing cancer-related symptoms that interfere with work, breast cancer specific quality of life measures, and a log book of work attendance. Cost effectiveness measures include EQ-5D-5L, ICECAP-A capability measure, work log book and cost of intervention delivery. Data analysis Quantitative Data Analysis Analysis will be based primarily on intention-to-treat comparing outcomes at baseline and post-intervention follow-up periods. A per protocol analysis will be conducted as sensitivity analysis only. Descriptive analyses will include frequencies (%), means (standard deviation, 95%CI) and medians (inter-quartile range, IQR) where appropriate. A baseline table of characteristics for all participants recruited and by sites recruiting will be presented to ensure balance achieved with randomisation. Numbers of those recruited from participating CCSC, numbers (percentage) of those randomised and enrolled into intervention, and numbers (percentage) adhering to the intervention and retained in the study will be examined. Qualitative data analysis All interviews will be audiotaped and transcribed verbatim. Analysis will be carried out using a computer software package, NVivo (available through TCD IS services). A content analysis approach will be used to explore commonalities between participants on their experiences of the intervention and to identify differences in experiences and opinions of the intervention. Within a content-analysis framework, both a deductive and inductive approach will be used for the analysis to identify new findings related to the CanWork intervention (inductive analysis) and to compare the findings of this study to previously reported research on work-focused interventions (i.e. deductive analysis). Cost effectiveness analysis The health economics analysis will consist of trial-based economic evaluation and will incorporate cost utility analysis to compare the alternative strategies: (1) the CanWork self-management intervention; and (2) usual practice. The economic evaluation will be undertaken in a manner consistent with the guidelines issued by Health Information and Quality Authority (HIQA) for the evaluation of healthcare interventions and technologies in Ireland. The basic tasks of the evaluation are to identify, measure, value and compare the costs and outcomes of the alternatives being considered.