Effectiveness of a Cancer Center Based Physical Activity Intervention

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Breast Cancer; Physical Activity
• Intervention / Treatment: Behavioral: Physical activity counseling

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Leo Jenkins Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 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: Physical activity counseling; Group receives face-to-face physical activity counseling.	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.
Active Comparator: Manual; Group receives physical activity manual.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: East Carolina University
• Investigators: Principal Investigator: Kristina H Karvinen, PhD, East Carolina University

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: May 25, 2010
• First Submitted That Met QC Criteria: July 30, 2010
• First Posted (Estimate): August 2, 2010

Study Record Updates

• Last Update Posted (Estimate): July 13, 2012
• Last Update Submitted That Met QC Criteria: July 12, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: IRB 09-0887