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Trial Title:
A Correlational Study: Breast Cancer-related Chest Wall Lymphedema, Quality of Life, and Shoulder Function
NCT ID:
NCT06285747
Condition:
Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Lymphedema
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Other
Intervention name:
Non-Interventional Study
Description:
Non-Interventional Study
Arm group label:
Observational
Summary:
This study evaluates how swelling in the chest following breast cancer treatment may
affect patients' quality of life and shoulder function.
Detailed description:
PRIMARY OBJECTIVES:
I. Determine if there is a correlation to Delfin Moisture Meter Compact D reading and
quality of life as measured by the LymQOL-midline.
II. Determine if there is a correlation to Delfin Moisture Meter Compact D reading and
DASH measure of shoulder function.
III. Determine how the presence of chest wall lymphedema as determined by physical exam
may affect an individual's quality of life as measured by the LymQOL-midline assessment.
IV. Determine how the presence of chest wall lymphedema as determined by physical exam
may shoulder function on the effected side, as measured by the Disabilities of the Arm,
Shoulder, and Hand questionnaire.
OUTLINE: This is an observational study.
Patients complete questionnaires and undergo chest wall and breast lymphedema
measurements by clinical assessment and using the Delfin Moisture Meter D Compact and
have their medical records reviewed on study.
Criteria for eligibility:
Study pop:
Women who have undergone surgical intervention for treatment of breast cancer.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Women of any age with diagnosis of any type of breast cancer
- Breast cancer on unilateral or bilateral side
- Surgical intervention for treatment of breast cancer
Exclusion Criteria:
- Previous shoulder injury or known shoulder limitation on affected side
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Kayla A. Van Der Weerd, PT, DPT
Phone:
507-266-8721
Email:
VanDerWeerd.Kayla@mayo.edu
Contact backup:
Last name:
Kayla A. Van Der Weerd, PT, DPT
Start date:
July 28, 2023
Completion date:
August 1, 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06285747
https://www.mayo.edu/research/clinical-trials
