Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy (PROACTIVE)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Physical Activity Resource Kit
Standard Materials
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, physical activity, quality of life, theory of planned behavior, behavior change, health promotion
Eligibility Criteria
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).
Sites / Locations
- Tom Baker Cancer CentreRecruiting
- Grande Prairie Cancer CentreRecruiting
- Lethbridge Cancer CentreRecruiting
- Medicine Hat Cancer CentreRecruiting
- Central Alberta Cancer CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PA Behavior Intervention
Standard Materials
Arm Description
Physical Activity Resource Kit
Receive physical activity handout from the Canadian Public Health Agency
Outcomes
Primary Outcome Measures
Self-reported physical activity
Secondary Outcome Measures
Cancer specific health related quality of life
Psychosocial health outcomes
Objective step counts (pedometer)
Chemotherapy completion rate
Determinants of physical activity
Physical functioning
Full Information
NCT ID
NCT01053468
First Posted
January 20, 2010
Last Updated
June 30, 2011
Sponsor
Athabasca University
Collaborators
University of Alberta, University of Calgary, Alberta Health services
1. Study Identification
Unique Protocol Identification Number
NCT01053468
Brief Title
Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy
Acronym
PROACTIVE
Official Title
Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
April 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Athabasca University
Collaborators
University of Alberta, University of Calgary, Alberta Health services
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, physical activity, quality of life, theory of planned behavior, behavior change, health promotion
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PA Behavior Intervention
Arm Type
Experimental
Arm Description
Physical Activity Resource Kit
Arm Title
Standard Materials
Arm Type
Active Comparator
Arm Description
Receive physical activity handout from the Canadian Public Health Agency
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Resource Kit
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Standard Materials
Intervention Description
Participants in this usual care group will receive a generic physical activity leaflet from the Canadian Public Health Agency
Primary Outcome Measure Information:
Title
Self-reported physical activity
Time Frame
Baseline, post intervention, 6 months follow up
Secondary Outcome Measure Information:
Title
Cancer specific health related quality of life
Time Frame
Baseline, post intervention, 6 months follow up
Title
Psychosocial health outcomes
Time Frame
Baseline, post intervention, 6 months follow up
Title
Objective step counts (pedometer)
Time Frame
Baseline, post intervention, 6 months follow up
Title
Chemotherapy completion rate
Time Frame
Baseline, post intervention, 6 months follow up
Title
Determinants of physical activity
Time Frame
Baseline, post intervention, 6 months follow up
Title
Physical functioning
Time Frame
Baseline, post intervention, 6 months follow up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeff Vallance, PhD
Phone
403-488-7179
Email
jeffv@athabascau.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Celeste Lavallee, BSc, RD
Email
clavallee@athabascau.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Vallance, PhD
Organizational Affiliation
Athabasca University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Name
Grande Prairie Cancer Centre
City
Grande Prairie
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Name
Lethbridge Cancer Centre
City
Lethbridge
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Name
Medicine Hat Cancer Centre
City
Medicine Hat
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Name
Central Alberta Cancer Centre
City
Red Deer
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy
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