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

This study is currently recruiting participants.
Verified January 2010 by Athabasca University
Sponsor:
Collaborators:
University of Alberta
University of Calgary
Alberta Health Services
Information provided by:
Athabasca University
ClinicalTrials.gov Identifier:
NCT01053468
First received: January 20, 2010
Last updated: June 30, 2011
Last verified: January 2010

January 20, 2010
June 30, 2011
August 2010
April 2012   (final data collection date for primary outcome measure)
Self-reported physical activity [ Time Frame: Baseline, post intervention, 6 months follow up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01053468 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
 
 
Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy
Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy

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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Breast Cancer
  • 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).

  • Behavioral: Standard Materials
    Participants in this usual care group will receive a generic physical activity leaflet from the Canadian Public Health Agency
  • Experimental: PA Behavior Intervention
    Physical Activity Resource Kit
    Intervention: Behavioral: Physical Activity Resource Kit
  • Active Comparator: Standard Materials
    Receive physical activity handout from the Canadian Public Health Agency
    Intervention: Behavioral: Standard Materials
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
April 2013
April 2012   (final data collection date for primary outcome measure)

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).
Female
18 Years to 75 Years
No
Contact: Jeff Vallance, PhD 403-488-7179 jeffv@athabascau.ca
Contact: Celeste Lavallee, BSc, RD clavallee@athabascau.ca
Canada
 
NCT01053468
PROACTIVE
No
Jeff Vallance, PhD, Athabasca University
Athabasca University
  • University of Alberta
  • University of Calgary
  • Alberta Health Services
Principal Investigator: Jeff Vallance, PhD Athabasca University
Athabasca University
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP