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

NCT00489125 | Completed DMC

• 4 other identifiers: CCCWFU 97305P30CA012197CCCWFU-97305CCCWFU-BG05-106
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Collection of data before surgery, at each follow-up visit, and at 2 years after surgery

  approximately 2 years

• Changes in physical activity participation, measures of body composition, shoulder range of motion, grip strength, and arm strength over time

  approximately 2 years

• Differences in changes in physical activity and indices of fitness according to type of surgery and adjuvant therapy

  approximately 2 years

• Relationships between exercise participation, fitness, and body composition over time

  approximately 2 years

• Correlation of data with an ongoing randomized exercise trial that includes strength and flexibility assessments with no pre-surgery measures

  approximately 2 years

Interventions

physiologic testing OTHER

physical testing of range of motion, grip strength etc.

Eligibility Criteria

• Age: Up to 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shannon Mihalko, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Edward A. Levine, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2007
• First Posted: June 21, 2007
• Study Start: October 15, 2004
• Primary Completion: July 20, 2018
• Study Completion: July 20, 2018
• Last Updated: June 4, 2019

Record last verified: 2019-05

Locations

US (1)