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Effectiveness of a Cancer Center Based Physical Activity Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kristina Karvinen, East Carolina University
ClinicalTrials.gov Identifier:
NCT01173861
First received: May 25, 2010
Last updated: July 12, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Breast Cancer
Quality of Life
Physical Activity
 Behavioral: Physical activity counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effectiveness of a Cancer Center Based Physical Activity Intervention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by East Carolina University:

Primary Outcome Measures:
  • Effectiveness of a cancer center based physical activity intervention for increasing physical activity in breast cancer survivors. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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:
  • Effectiveness of a cancer center based physical activity counseling intervention on increasing quality of life in breast cancer survivors. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: March 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Kristina Karvinen, Assistant Professor, East Carolina University
ClinicalTrials.gov Identifier: NCT01173861     History of Changes
Other Study ID Numbers: IRB 09-0887
Study First Received: May 25, 2010
Last Updated: July 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013