Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy (PROACTIVE)
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|ClinicalTrials.gov Identifier: NCT01053468|
Recruitment Status : Unknown
Verified January 2010 by Athabasca University.
Recruitment status was: Recruiting
First Posted : January 21, 2010
Last Update Posted : July 1, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Physical Activity Resource Kit Behavioral: Standard Materials||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||April 2012|
|Estimated Study Completion Date :||April 2013|
Experimental: PA Behavior Intervention
Physical Activity Resource Kit
Behavioral: Physical Activity Resource Kit
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).
Active Comparator: Standard Materials
Receive physical activity handout from the Canadian Public Health Agency
Behavioral: Standard Materials
Participants in this usual care group will receive a generic physical activity leaflet from the Canadian Public Health Agency
- Self-reported physical activity [ Time Frame: Baseline, post intervention, 6 months follow up ]
- Cancer specific health related quality of life [ Time Frame: Baseline, post intervention, 6 months follow up ]
- Psychosocial health outcomes [ Time Frame: Baseline, post intervention, 6 months follow up ]
- Objective step counts (pedometer) [ Time Frame: Baseline, post intervention, 6 months follow up ]
- Chemotherapy completion rate [ Time Frame: Baseline, post intervention, 6 months follow up ]
- Determinants of physical activity [ Time Frame: Baseline, post intervention, 6 months follow up ]
- Physical functioning [ Time Frame: Baseline, post intervention, 6 months follow up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053468
|Contact: Jeff Vallance, PhDemail@example.com|
|Contact: Celeste Lavallee, BSc, RDfirstname.lastname@example.org|
|Tom Baker Cancer Centre||Recruiting|
|Calgary, Alberta, Canada|
|Grande Prairie Cancer Centre||Recruiting|
|Grande Prairie, Alberta, Canada|
|Lethbridge Cancer Centre||Recruiting|
|Lethbridge, Alberta, Canada|
|Medicine Hat Cancer Centre||Recruiting|
|Medicine Hat, Alberta, Canada|
|Central Alberta Cancer Centre||Recruiting|
|Red Deer, Alberta, Canada|
|Principal Investigator:||Jeff Vallance, PhD||Athabasca University|