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Effectiveness of a Cancer Center Based Physical Activity Intervention

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ClinicalTrials.gov Identifier: NCT01173861
Recruitment Status : Completed
First Posted : August 2, 2010
Last Update Posted : July 13, 2012
Sponsor:
Information provided by (Responsible Party):
Kristina Karvinen, East Carolina University

Brief 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


Condition or disease Intervention/treatment Phase
Breast Cancer Quality of Life Physical Activity Behavioral: Physical activity counseling Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of a Cancer Center Based Physical Activity Intervention
Study Start Date : March 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Effectiveness of a cancer center based physical activity intervention for increasing physical activity in breast cancer survivors. [ Time Frame: 8 weeks ]
    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.


Secondary Outcome Measures :
  1. Effectiveness of a cancer center based physical activity counseling intervention on increasing quality of life in breast cancer survivors. [ Time Frame: 8 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173861


Locations
United States, North Carolina
Leo Jenkins Cancer Center
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
East Carolina University
Investigators
Principal Investigator: Kristina H Karvinen, PhD East Carolina University

Responsible Party: Kristina Karvinen, Assistant Professor, East Carolina University
ClinicalTrials.gov Identifier: NCT01173861     History of Changes
Other Study ID Numbers: IRB 09-0887
First Posted: August 2, 2010    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2012