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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2012

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).

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: PA Behavior Intervention
    • Physical Activity Resource Kit
  • Active Comparator: Standard Materials
    • Receive physical activity handout from the Canadian Public Health Agency

Clinical Trial Outcome Measures

Primary Measures

  • Self-reported physical activity
    • Time Frame: Baseline, post intervention, 6 months follow up

Secondary Measures

  • Cancer specific health related quality of life
    • Time Frame: Baseline, post intervention, 6 months follow up
  • Psychosocial health outcomes
    • Time Frame: Baseline, post intervention, 6 months follow up
  • Objective step counts (pedometer)
    • Time Frame: Baseline, post intervention, 6 months follow up
  • Chemotherapy completion rate
    • Time Frame: Baseline, post intervention, 6 months follow up
  • Determinants of physical activity
    • Time Frame: Baseline, post intervention, 6 months follow up
  • Physical functioning
    • Time Frame: Baseline, post intervention, 6 months follow up

Participating in This Clinical Trial

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).

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Athabasca University
  • Collaborator
    • University of Alberta
  • Provider of Information About this Clinical Study
    • Jeff Vallance, PhD, Athabasca University
  • Overall Official(s)
    • Jeff Vallance, PhD, Principal Investigator, Athabasca University
  • Overall Contact(s)
    • Jeff Vallance, PhD, 403-488-7179, jeffv@athabascau.ca

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