Arm Function and Quality of Life Following Mastectomy.
This study has been completed.
Sponsor:
University of New Mexico
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
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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 May 23, 2013