Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy

Study Overview
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Brief Summary
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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
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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).

Official Title
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Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Physical Activity Resource Kit
* Behavioral: Standard Materials


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PA Behavior Intervention<br>Physical Activity Resource Kit | Behavioral: Physical Activity Resource Kit<br>* The Intervention group (INT) will receive a Physical Activity Resource Kit which includes a step pedometer, a breast cancer-specific Physical Activity Guidebook (Exercise for health), a step pedometer resource (Step into survivorship), and a physical activity and step journal to record their daily step totals and daily physical activities. Participants will be instructed to wear their pedometer for the entire duration of the study (i.e., chemotherapy duration).<br>|
| Active Comparator: Standard Materials<br>Receive physical activity handout from the Canadian Public Health Agency | Behavioral: Standard Materials<br>* Participants in this usual care group will receive a generic physical activity leaflet from the Canadian Public Health Agency<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported physical activity |  | Baseline, post intervention, 6 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer specific health related quality of life |  | Baseline, post intervention, 6 months follow up | 
| Psychosocial health outcomes |  | Baseline, post intervention, 6 months follow up | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, physical activity, quality of life, theory of planned behavior, behavior change, health promotion