Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Athabasca University
- Enrollment
- 150
- Locations
- 5
- Primary Endpoint
- Self-reported physical activity
Study Overview
Brief Summary
Breast cancer and its treatments can take a toll on the physical and psychosocial well-being of cancer survivors. Few interventions can help breast cancer patients improve their physical strength, stamina, and overall well-being. Developing ways to facilitate PA behavior during chemotherapy for breast cancer are necessary. This trial explores ways that breast cancer patients receiving chemotherapy can learn about and engage in PA during chemotherapy. This trial will also give Southern Alberta breast cancer survivors an opportunity to participate in evidence-based programs designed to facilitate their health, breast cancer recovery, and disease-free survival.
The investigators primary hypothesis is that women receiving the PA intervention resource kit will report a more positive change in self-reported PA at the end of chemotherapy treatments when compared to the group receiving standard materials.
Detailed Description
Primary Objective:
To compare the effects of an evidence-based intervention consisting of targeted breast-cancer specific PA print materials (i.e., Exercise for health), a step pedometer, a step-walking guidebook (i.e., Step into survivorship), and a physical activity and step journal (INT) to a comparison group receiving a generic, two-page public health PA resource (Standard Material: SM).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •are diagnosed with stage I -IIIA breast cancer
- •are scheduled to receive neoadjuvant or adjuvant chemotherapy
- •did not receive transabdominal rectus abdominus muscle (TRAM) reconstructive surgery
- •are >18 years of age
- •receive approval from their treating oncologist to participate
- •do not have uncontrolled hypertension, cardiac illness, or psychiatric conditions (i.e., indicated in patient medical charts).
Exclusion Criteria
- Not provided
Arms & Interventions
PA Behavior Intervention
Physical Activity Resource Kit
Intervention: Physical Activity Resource Kit (Behavioral)
Standard Materials
Receive physical activity handout from the Canadian Public Health Agency
Intervention: Standard Materials (Behavioral)
Outcomes
Primary Outcomes
Self-reported physical activity
Time Frame: Baseline, post intervention, 6 months follow up
Secondary Outcomes
- Objective step counts (pedometer)(Baseline, post intervention, 6 months follow up)
- Chemotherapy completion rate(Baseline, post intervention, 6 months follow up)
- Determinants of physical activity(Baseline, post intervention, 6 months follow up)
- Physical functioning(Baseline, post intervention, 6 months follow up)
- Cancer specific health related quality of life(Baseline, post intervention, 6 months follow up)
- Psychosocial health outcomes(Baseline, post intervention, 6 months follow up)