Strength and Range of Motion in Women Undergoing Surgery for Breast Cancer

NCT ID: NCT00489125

Last Updated: 2019-06-04

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

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-15

Study Completion Date

2018-07-20

Brief Summary

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RATIONALE: Gathering information about strength and range of motion over time from women undergoing surgery for breast cancer may help doctors learn more about recovery from surgery and on-going care.

PURPOSE: This clinical trial is collecting information about strength and range of motion over time from women undergoing surgery for breast cancer.

Detailed Description

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OBJECTIVES:

* Collect data regarding diagnosis, type of surgery, receipt of adjuvant therapy, age, height, weight, waist circumference, arm strength, grip strength, shoulder range of motion, and physical activity participation from women undergoing surgery for breast cancer.
* Examine changes in physical activity participation, measures of body composition, shoulder range of motion, grip strength, and arm strength over time in these patients.
* Determine differences in changes in physical activity and indices of fitness according to type of surgery and adjuvant therapy.
* Examine relationships between exercise participation, fitness, and body composition over time.
* Correlate data with an ongoing randomized exercise trial that includes strength and flexibility assessments with no pre-surgery measures.

OUTLINE: This is a prospective, cohort study.

Patients submit data comprising demographic/medical information, anthropometrics (weight, height, waist circumference), grip strength, bicep strength, shoulder range of motion, and physical activity participation prior to surgery, at each surgical follow-up visit, and at 2 years after surgery.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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physiologic testing

physical testing of range of motion, grip strength etc.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of breast cancer

* Stage I-IV disease
* Planning to undergo surgery at the Comprehensive Cancer Center Breast Clinic at Wake Forest University Baptist Medical Center
Maximum Eligible Age

120 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shannon Mihalko, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Edward A. Levine, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CCCWFU-97305

Identifier Type: -

Identifier Source: secondary_id

CCCWFU-BG05-106

Identifier Type: -

Identifier Source: secondary_id

CCCWFU 97305

Identifier Type: -

Identifier Source: org_study_id

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