NCT00379106

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2003

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

January 7, 2010

Status Verified

March 1, 2008

Enrollment Period

2.2 years

First QC Date

September 19, 2006

Last Update Submit

January 6, 2010

Conditions

Breast Cancer

Keywords

SupportiveMastectomyQuality of LifeArm Function

Outcome Measures

Primary Outcomes (1)

  • Arm Function and Quality of Life Following Mastectomy

    Motion measurements will be taken at the first session, 1 month, 6 weeks, 3 months, 6 months and 1 year

Study Arms (2)

Group1

ACTIVE COMPARATOR
Procedure: Arm exercises.

Group 2

EXPERIMENTAL
Procedure: Arm Exercises

Interventions

Arm ExercisesPROCEDURE

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

Group 2

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Not specified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87130, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kathy Dieruf

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2006

First Posted

September 21, 2006

Study Start

October 1, 2003

Primary Completion

December 1, 2005

Study Completion

September 1, 2007

Last Updated

January 7, 2010

Record last verified: 2008-03

Locations

US(1)