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

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: Breast Cancer
• Intervention / Treatment: Behavioral: Physical Activity Resource Kit; Behavioral: Standard Materials

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

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Baseline, post intervention, 6 months follow up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Athabasca University
• Collaborators: Alberta Health services; University of Alberta; University of Calgary
• Investigators: Principal Investigator: Jeff Vallance, PhD, Athabasca University

Study record dates

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: physical activity; breast cancer; quality of life; health promotion; behavior change; theory of planned behavior
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PROACTIVE