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

June 30, 2011 updated by: Athabasca University

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Recruiting
        • Tom Baker Cancer Centre
      • Grande Prairie, Alberta, Canada
        • Recruiting
        • Grande Prairie Cancer Centre
      • Lethbridge, Alberta, Canada
        • Recruiting
        • Lethbridge Cancer Centre
      • Medicine Hat, Alberta, Canada
        • Recruiting
        • Medicine Hat Cancer Centre
      • Red Deer, Alberta, Canada
        • Recruiting
        • Central Alberta Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Athabasca University

Collaborators

Alberta Health services
University of Alberta
University of Calgary

Investigators

  • Principal Investigator: Jeff Vallance, PhD, Athabasca University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

April 1, 2012

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

January 20, 2010

First Submitted That Met QC Criteria

January 20, 2010

First Posted (Estimate)

January 21, 2010

Study Record Updates

Last Update Posted (Estimate)

July 1, 2011

Last Update Submitted That Met QC Criteria

June 30, 2011

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROACTIVE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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