Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy (PROACTIVE)
Recruitment status was Recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Behavioral: Physical Activity Resource Kit Behavioral: Standard Materials |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy |
- Self-reported physical activity [ Time Frame: Baseline, post intervention, 6 months follow up ] [ Designated as safety issue: No ]
- Cancer specific health related quality of life [ Time Frame: Baseline, post intervention, 6 months follow up ] [ Designated as safety issue: No ]
- Psychosocial health outcomes [ Time Frame: Baseline, post intervention, 6 months follow up ] [ Designated as safety issue: No ]
- Objective step counts (pedometer) [ Time Frame: Baseline, post intervention, 6 months follow up ] [ Designated as safety issue: No ]
- Chemotherapy completion rate [ Time Frame: Baseline, post intervention, 6 months follow up ] [ Designated as safety issue: No ]
- Determinants of physical activity [ Time Frame: Baseline, post intervention, 6 months follow up ] [ Designated as safety issue: No ]
- Physical functioning [ Time Frame: Baseline, post intervention, 6 months follow up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | 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).
Contacts and Locations| Contact: Jeff Vallance, PhD | 403-488-7179 | jeffv@athabascau.ca |
| Contact: Celeste Lavallee, BSc, RD | clavallee@athabascau.ca |
| Canada, Alberta | |
| 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 |
More Information
No publications provided
| Responsible Party: | Jeff Vallance, PhD, Athabasca University |
| ClinicalTrials.gov Identifier: | NCT01053468 History of Changes |
| Other Study ID Numbers: | PROACTIVE |
| Study First Received: | January 20, 2010 |
| Last Updated: | June 30, 2011 |
| Health Authority: | Canada: Canadian Institutes of Health Research |
Keywords provided by Athabasca University:
|
breast cancer physical activity quality of life |
theory of planned behavior behavior change health promotion |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013