Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy (PROACTIVE)
Tracking Information | |||||||||
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First Received Date ICMJE | January 20, 2010 | ||||||||
Last Updated Date | June 30, 2011 | ||||||||
Start Date ICMJE | August 2010 | ||||||||
Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Self-reported physical activity [ Time Frame: Baseline, post intervention, 6 months follow up ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01053468 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy | ||||||||
Official Title ICMJE | Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy | ||||||||
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. |
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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). |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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Condition ICMJE | Breast Cancer | ||||||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 150 | ||||||||
Estimated Completion Date | April 2013 | ||||||||
Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Gender | Female | ||||||||
Ages | 18 Years to 75 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Canada | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01053468 | ||||||||
Other Study ID Numbers ICMJE | PROACTIVE | ||||||||
Has Data Monitoring Committee | No | ||||||||
Responsible Party | Jeff Vallance, PhD, Athabasca University | ||||||||
Study Sponsor ICMJE | Athabasca University | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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Information Provided By | Athabasca University | ||||||||
Verification Date | January 2010 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |