Testing the Effectiveness of a Work Rehabilitation Intervention for Women with Breast Cancer
NCT ID: NCT06723899
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
248 participants
INTERVENTIONAL
2024-11-13
2028-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
CanWork
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.
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
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CanWork
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
70 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Control Programme, Ireland
UNKNOWN
Royal College of Surgeons, Ireland
OTHER
University of Galway
OTHER
University of Dublin, Trinity College
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Deirdre Connolly
Professor in Occupational Therapy
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Deirdre Connolly, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Dublin, Trinity College
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cancer Care West
Galway, , Ireland
Solas Cancer Support Centre
Waterford, , Ireland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Helen Greally, PhD
Role: primary
Helen Greally, PhD
Role: backup
Tracy M McDaid, MSc
Role: primary
Tracy McDaid, MSc
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TRI-CFR 23-06
Identifier Type: -
Identifier Source: org_study_id