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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Athabasca University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Alberta
University of Calgary
AHS Cancer Control Alberta
Information provided by:
Athabasca University
ClinicalTrials.gov Identifier:
NCT01053468
First received: January 20, 2010
Last updated: June 30, 2011
Last verified: January 2010
  Purpose

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 Intervention Phase
Breast Cancer
Behavioral: Physical Activity Resource Kit
Behavioral: Standard Materials
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy

Resource links provided by NLM:


Further study details as provided by Athabasca University:

Primary Outcome Measures:
  • Self-reported physical activity [ Time Frame: Baseline, post intervention, 6 months follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: August 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053468

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

Locations
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
AHS Cancer Control Alberta
Investigators
Principal Investigator: Jeff Vallance, PhD Athabasca University
  More Information

No publications provided

Responsible Party: Jeff Vallance, PhD, Athabasca University
ClinicalTrials.gov Identifier: NCT01053468     History of Changes
Other Study ID Numbers: PROACTIVE
Study First Received: January 20, 2010
Last Updated: June 30, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Athabasca University:
breast cancer
physical activity
quality of life
theory of planned behavior
behavior change
health promotion

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 15, 2014