Status:
UNKNOWN
Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women With Breast Cancer
Lead Sponsor:
University of Missouri, Kansas City
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-89 years
Phase:
NA
Brief Summary
The goal of this two-phase project is to adapt The-Optimal-Lymph-Flow (TOLF) behavioral intervention to be culturally appropriate, and subsequently test the intervention in Black and Hispanic patients...
Detailed Description
PURPOSE/SPECIFIC AIMS The purpose of this project is to adapt The-Optimal-Lymph-Flow (TOLF) behavioral intervention to be culturally appropriate, and subsequently test the intervention in Black and Hi...
Eligibility Criteria
Inclusion
- The participants are Black and Hispanic women (over age 18) with lymphatic pain following breast cancer treatment. These women will be recruited for the Phase I focus groups (N=24), and the Phase II RCT (N=60). Participants will include women who 1) have received surgical treatment for breast cancer at least 3 months prior to the study enrollment, 2) report persistent or intermittent pain/aching/soreness in the ipsilateral body or upper limb; 3) self-identify as either Black or Hispanic; and 4) are able to understand the study protocols presented in English.
Exclusion
- Exclusion criteria include: 1) presence of a serious psychiatric condition (e.g., schizophrenia, suicidal intent) indicated by medical chart, treating oncologist or other staff, or study staff interactions that would contraindicate safe study participation; 2) known metastatic disease (Stage IV), recurrence of cancer, or lymphedema due to cancer recurrence, or other bulk disease in the thoracic or cervical regions; 3) were diagnosed or treated for lymphedema.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06133959
Start Date
December 1 2023
End Date
December 31 2025
Last Update
November 22 2023
Active Locations (1)
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1
University of Missouri-Kansas City
Kansas City, Missouri, United States, 64108