Arm Function and Quality of Life Following Mastectomy.

This study has been completed.
Sponsor:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00379106
First received: September 19, 2006
Last updated: January 6, 2010
Last verified: March 2008
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Arm Function and Quality of Life Following Mastectomy.

Resource links provided by NLM:


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
Active Comparator: Group1 Procedure: Arm exercises.
Basic active exercise program at home.
Experimental: Group 2 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: Kathy Dieruf, MD; Principal Investigator, Universtiy of New Mexico - CRTC
ClinicalTrials.gov Identifier: NCT00379106     History of Changes
Other Study ID Numbers: 1002C
Study First Received: September 19, 2006
Last Updated: January 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
Supportive
Mastectomy
Quality of Life
Arm Function

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

ClinicalTrials.gov processed this record on April 15, 2014