Arm Function and Quality of Life Following Mastectomy.

NCT ID: NCT00379106

Last Updated: 2010-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2007-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group1

Group Type ACTIVE_COMPARATOR

Arm exercises.

Intervention Type PROCEDURE

Basic active exercise program at home.

Group 2

Group Type EXPERIMENTAL

Arm Exercises

Intervention Type PROCEDURE

Instruction in the same active exercise program along with additional exercises using exercise equipment and stretching exercises

Interventions

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Arm exercises.

Basic active exercise program at home.

Intervention Type PROCEDURE

Arm Exercises

Instruction in the same active exercise program along with additional exercises using exercise equipment and stretching exercises

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not specified
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Universtiy of New Mexico - CRTC

Principal Investigators

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Kathy Dieruf

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

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University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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1002C

Identifier Type: -

Identifier Source: org_study_id

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