Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy
PROACTIVE
1 other identifier
interventional
150
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Aug 2010
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2010
CompletedFirst Posted
Study publicly available on registry
January 21, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJuly 1, 2011
January 1, 2010
1.7 years
January 20, 2010
June 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Self-reported physical activity
Baseline, post intervention, 6 months follow up
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
PA Behavior Intervention
EXPERIMENTALPhysical Activity Resource Kit
Standard Materials
ACTIVE COMPARATORReceive physical activity handout from the Canadian Public Health Agency
Interventions
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).
Participants in this usual care group will receive a generic physical activity leaflet from the Canadian Public Health Agency
Eligibility Criteria
You may qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Athabasca Universitylead
- University of Albertacollaborator
- University of Calgarycollaborator
- Alberta Health servicescollaborator
Study Sites (5)
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Grande Prairie Cancer Centre
Grande Prairie, Alberta, Canada
Lethbridge Cancer Centre
Lethbridge, Alberta, Canada
Medicine Hat Cancer Centre
Medicine Hat, Alberta, Canada
Central Alberta Cancer Centre
Red Deer, Alberta, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeff Vallance, PhD
Athabasca University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 20, 2010
First Posted
January 21, 2010
Study Start
August 1, 2010
Primary Completion
April 1, 2012
Study Completion
April 1, 2013
Last Updated
July 1, 2011
Record last verified: 2010-01