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

Phase 2

• Conditions: Breast Cancer

• Registration Number: NCT01053468
• Lead Sponsor: Athabasca University

Brief Summary

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.

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 Timeline

• Status Verified: 2010-01
• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Study Start: 2010-08
• Last Update Submitted: 2011-06-30
• Last Update Posted: 2011-07-01
• Primary Completion: 2012-04
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-reported physical activity	Baseline, post intervention, 6 months follow up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada

Grande Prairie Cancer Centre; 🇨🇦 Grande Prairie, Alberta, Canada

Lethbridge Cancer Centre; 🇨🇦 Lethbridge, Alberta, Canada

Medicine Hat Cancer Centre; 🇨🇦 Medicine Hat, Alberta, Canada

Central Alberta Cancer Centre; 🇨🇦 Red Deer, Alberta, Canada