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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014