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

Breast Cancer Clinical Trial

— PROACTIVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01053468
• Other study ID #: PROACTIVE
• Status: Recruiting
• Phase: Phase 2
• First received: January 20, 2010
• Last updated: June 30, 2011
• Start date: August 2010
• Est. completion date: April 2013

Study information

• Verified date: January 2010
• Source: Athabasca University
• Contact: Jeff Vallance, PhD
• Phone: 403-488-7179
• Email: jeffv[@]athabascau.ca
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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).
• Standard Materials
Participants in this usual care group will receive a generic physical activity leaflet from the Canadian Public Health Agency

Locations

Country	Name	City	State
Canada	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

Sponsors (4)

Lead Sponsor	Collaborator
Athabasca University	Alberta Health Services, University of Alberta, University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported physical activity		Baseline, post intervention, 6 months follow up	No
Secondary	Cancer specific health related quality of life		Baseline, post intervention, 6 months follow up	No
Secondary	Psychosocial health outcomes		Baseline, post intervention, 6 months follow up	No
Secondary	Objective step counts (pedometer)		Baseline, post intervention, 6 months follow up	No
Secondary	Chemotherapy completion rate		Baseline, post intervention, 6 months follow up	No
Secondary	Determinants of physical activity		Baseline, post intervention, 6 months follow up	No
Secondary	Physical functioning		Baseline, post intervention, 6 months follow up	No