Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women With Breast Cancer

Status unconfirmed · Not applicable

Conditions studied: Breast Cancer

In brief

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. The investigators have developed and tested behavioral intervention program TOLF that builds patients' self-management skills to promote lymph flow and results in complete pain reduction, reduced lymph fluid level, reversed mild lymphedema, and improved quality of life (QOL). Of concern, this promising intervention has not been adapted to reduce patient barriers (e.g., relevance, cost, time, travel, competing demands) and system barriers (e.g., intervention availability, staffing, therapist) to timely interventions faced by Black and Hispanic women. Specific aims are to: Aim 1: Engage Black and Hispanic women (N=24) in adapting TOLF to be highly culturally appropriate. The investigators will conduct focus groups to refine TOLF focusing on barriers faced by and preferences of Black and Hispanic women. Aim 2: Conduct a pilot randomized controlled trial (RCT) (N=60) equally allocating women to either 1) TOLF or 2) lymphedema education (e-Lymph) to examine feasibility, acceptability, and examine primary outcomes (lymphatic pain, pain severity and interference, and lymph fluid level) and secondary outcomes (daily living function, psychological distress, QOL, self-efficacy for pain management) of the culturally appropriate behavioral interventions.

Key facts

Study ID

NCT06133959

Run by

University of Missouri, Kansas City

People needed

60

Starts

2023-12-01

Expected to finish

2025-12-31

Last updated by the study team

2023-11-22

Who can join

Age: 18 and older, up to 89. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Missouri-Kansas City — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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