Arm Function and Quality of Life Following Mastectomy. - Full Text View

Sponsored by:	University of New Mexico
Information provided by:	University of New Mexico
ClinicalTrials.gov Identifier:	NCT00379106

Purpose

To measure arm function and quality of life of mastectomy patients.

Condition	Intervention
Breast Cancer	Procedure: Arm exercises. Procedure: Arm Exercises

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Exercise and Physical Fitness Mastectomy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Arm Function and Quality of Life Following Mastectomy.

Further study details as provided by University of New Mexico:

Primary Outcome Measures:

Arm Function and Quality of Life Following Mastectomy [ Time Frame: Motion measurements will be taken at the first session, 1 month, 6 weeks, 3 months, 6 months and 1 year ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	October 2003
Study Completion Date:	September 2007
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group1: Active Comparator	Procedure: Arm exercises. Basic active exercise program at home.
Group 2: Experimental	Procedure: Arm Exercises Instruction in the same active exercise program along with additional exercises using exercise equipment and stretching exercises

Detailed Description:

Treatment: Randomized to one of two treatment arms. Group One: Basic active exercise program at home. Group Two: Instruction in the same active exercise program along with additional exercises using exercise equipment and stretching exercises. Range of Motion measurements will be taken at the first session, 1 month, 6 weeks, 3 months, 6 months and 1 year. Patients will complete demographic form, functional questionnaire, and QOL questionnaire.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who have been referred from UNMH to CRTC for further treatment following mastectomy/lumpectomy surgery.

Exclusion Criteria:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379106

Locations

United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87130

Sponsors and Collaborators

University of New Mexico

Investigators

Principal Investigator:

Kathy Dieruf

University of New Mexico

More Information

No publications provided

Responsible Party:	Universtiy of New Mexico - CRTC ( Kathy Dieruf, MD; Principal Investigator )
Study ID Numbers:	1002C
Study First Received:	September 19, 2006
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00379106 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of New Mexico:

Supportive
Mastectomy
Quality of Life
Arm Function

Study placed in the following topic categories:

Skin Diseases
Quality of Life
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009