Clinical trial NCT00489125: Strength and Range of Motion in Women Undergoing Surgery for Breast Cancer
Official title: Breast Clinic Strength and Range of Motion Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-06-21
Enrollment: 400
Sex: FEMALE
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Collection of data before surgery, at each follow-up visit, and at 2 years after surgery
timeFrame: approximately 2 years
measure: Changes in physical activity participation, measures of body composition, shoulder range of motion, grip strength, and arm strength over time
timeFrame: approximately 2 years
measure: Differences in changes in physical activity and indices of fitness according to type of surgery and adjuvant therapy
timeFrame: approximately 2 years
measure: Relationships between exercise participation, fitness, and body composition over time
timeFrame: approximately 2 years
measure: Correlation of data with an ongoing randomized exercise trial that includes strength and flexibility assessments with no pre-surgery measures
timeFrame: approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Shannon Mihalko, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Edward A. Levine, MD
role: PRINCIPAL_INVESTIGATOR
References: