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Arm Function and Quality of Life Following Mastectomy.

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ClinicalTrials.gov Identifier: NCT00379106
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : January 7, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
To measure arm function and quality of life of mastectomy patients.

Condition or disease Intervention/treatment
Breast Cancer Procedure: Arm exercises. Procedure: Arm 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Arm Function and Quality of Life Following Mastectomy.
Study Start Date : October 2003
Primary Completion Date : December 2005
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kathy Dieruf, MD; Principal Investigator, Universtiy of New Mexico - CRTC
ClinicalTrials.gov Identifier: NCT00379106     History of Changes
Other Study ID Numbers: 1002C
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: January 7, 2010
Last Verified: March 2008

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