Effectiveness of a Cancer Center Based Physical Activity Intervention

Breast Cancer Clinical Trial

Official title:

Effectiveness of a Cancer Center Based Physical Activity Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01173861
• Other study ID #: IRB 09-0887
• Status: Completed
• Phase: N/A
• First received: May 25, 2010
• Last updated: July 12, 2012
• Start date: March 2010
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Purpose: Examine the effectiveness of cancer center-based physical activity counseling on physical activity rates and quality of life in breast cancer survivors.

Hypothesis: Participants in the intervention group will indicate greater step counts and quality of life at the end of the intervention compared to the control group

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of breast cancer within the last 5 years

• Over the age of 18 years

• female

Exclusion Criteria:

• Non-ambulatory

• Poor cognitive function

• Contraindications for exercise as determined by the PAR-Q

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Physical Activity
• Quality of Life

Intervention

Behavioral:
• Physical activity counseling
20-30 minutes of face-to-face physical activity counseling using motivational interviewing followed by 3 20 minute telephone counseling sessions.

Locations

Country	Name	City	State
United States	Leo Jenkins Cancer Center	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
East Carolina University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of a cancer center based physical activity intervention for increasing physical activity in breast cancer survivors.	The primary outcome is to examine the effectiveness of a cancer center based physical activity intervention on increasing physical activity as measured by step counts on a pedometer.	8 weeks	No
Secondary	Effectiveness of a cancer center based physical activity counseling intervention on increasing quality of life in breast cancer survivors.	The secondary outcome is to examine the effectiveness of a cancer center based physical activity counseling intervention on improving quality of life in breast cancer survivors.	8 weeks	No