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Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy (PROACTIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
University of Alberta
University of Calgary
Alberta Health services
Information provided by:
Athabasca University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Physical Activity Resource Kit Behavioral: Standard Materials Phase 2

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Self-reported physical activity [ Time Frame: Baseline, post intervention, 6 months follow up ]

Secondary Outcome Measures :
  1. Cancer specific health related quality of life [ Time Frame: Baseline, post intervention, 6 months follow up ]
  2. Psychosocial health outcomes [ Time Frame: Baseline, post intervention, 6 months follow up ]
  3. Objective step counts (pedometer) [ Time Frame: Baseline, post intervention, 6 months follow up ]
  4. Chemotherapy completion rate [ Time Frame: Baseline, post intervention, 6 months follow up ]
  5. Determinants of physical activity [ Time Frame: Baseline, post intervention, 6 months follow up ]
  6. Physical functioning [ Time Frame: Baseline, post intervention, 6 months follow up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Jeff Vallance, PhD 403-488-7179 jeffv@athabascau.ca
Contact: Celeste Lavallee, BSc, RD clavallee@athabascau.ca

Locations
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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
Sponsors and Collaborators
Athabasca University
University of Alberta
University of Calgary
Alberta Health services
Investigators
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Principal Investigator: Jeff Vallance, PhD Athabasca University
More Information
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Responsible Party: Jeff Vallance, PhD, Athabasca University
ClinicalTrials.gov Identifier: NCT01053468    
Other Study ID Numbers: PROACTIVE
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: July 1, 2011
Last Verified: January 2010
Keywords provided by Athabasca University:
breast cancer
physical activity
quality of life
 theory of planned behavior
behavior change
health promotion
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases