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

May 31, 2019 updated by: Wake Forest University Health Sciences

Breast Clinic Strength and Range of Motion Study

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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

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

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- North Carolina
  - Winston-Salem, North Carolina, United States, 27157-1096
    - Wake Forest University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2004

Primary Completion (Actual)

July 20, 2018

Study Completion (Actual)

July 20, 2018

Study Registration Dates

First Submitted

June 20, 2007

First Submitted That Met QC Criteria