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

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ClinicalTrials.gov Identifier: NCT00489125
Recruitment Status : Active, not recruiting
First Posted : June 21, 2007
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

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 or disease Intervention/treatment
Breast Cancer Other: physiologic testing

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.


Study Type : Observational
Estimated Enrollment : 275 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breast Clinic Strength and Range of Motion Study
Study Start Date : March 2005
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources


Intervention Details:
    Other: physiologic testing
    physical testing of range of motion, grip strength etc.


Primary Outcome Measures :
  1. Collection of data before surgery, at each follow-up visit, and at 2 years after surgery [ Time Frame: approximately 2 years ]
  2. 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 ]
  3. Differences in changes in physical activity and indices of fitness according to type of surgery and adjuvant therapy [ Time Frame: approximately 2 years ]
  4. Relationships between exercise participation, fitness, and body composition over time [ Time Frame: approximately 2 years ]
  5. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes 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

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): NCT00489125


Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Principal Investigator: Shannon Mihalko, PhD Wake Forest University Health Sciences
Principal Investigator: Edward A. Levine, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00489125     History of Changes
Other Study ID Numbers: CCCWFU 97305
P30CA012197 ( U.S. NIH Grant/Contract )
CCCWFU-97305
CCCWFU-BG05-106
First Posted: June 21, 2007    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
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