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

This study is currently recruiting participants.
Verified January 2013 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00489125
First received: June 20, 2007
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
 Other: physiologic testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breast Clinic Strength and Range of Motion Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Collection of data before surgery, at each follow-up visit, and at 2 years after surgery [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Changes in physical activity participation, measures of body composition, shoulder range of motion, grip strength, and arm strength over time [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Differences in changes in physical activity and indices of fitness according to type of surgery and adjuvant therapy [ Time Frame: approximately 2 years ] [ Designated as safety issue: Yes ]
  • Relationships between exercise participation, fitness, and body composition over time [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Correlation of data with an ongoing randomized exercise trial that includes strength and flexibility assessments with no pre-surgery measures [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 275
Study Start Date: March 2005
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: physiologic testing
    physical testing of range of motion, grip strength etc.
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any woman treated in the Breast Clinic of WFUBMC with a diagnosis of stage 0-IV breast cancer and identified as a candidate by their surgeon.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489125

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive     336-713-6771        
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Shannon Mihalko, PhD Comprehensive Cancer Center of Wake Forest University
Principal Investigator: Edward A. Levine, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00489125     History of Changes
Other Study ID Numbers: CDR0000550057, P30CA012197, CCCWFU-97305, CCCWFU-BG05-106
Study First Received: June 20, 2007
Last Updated: January 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
long-term effects secondary to cancer therapy in adults
recurrent breast cancer
stage I breast cancer
stage II breast cancer
 stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013