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

NCT06133959 | Unknown DMC

• 2 other identifiers: 2098673RE33
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Breast Cancer

Keywords

pain; lymphedema; breast cancer; behavior; intervention

Outcome Measures

Primary Outcomes (2)

• Lymphatic Pain

  The Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part I, a reliable and valid self-report instrument, is used to assess self-reported lymphatic pain, i.e., aching or soreness or tenderness.

  Pre-intervention (0 week) and Post-intervention (13 week)

• Pain Severity and Interference

  Brief Pain Inventory-Short Form (BPI-SF) will be used to measure pain severity and interference. The measure demonstrated reliability and validity.65 The BPI-SF consists of four items assessing pain severity (worst, least, average, and current pain) and seven items assessing pain interference in the past week.

  Pre-intervention (0 week) and Post-intervention (13 week)

Secondary Outcomes (5)

• Lymph Fluid Level

  Pre-intervention (0 week) and Post-intervention (13 week)

• Daily Living Function:

  Pre-intervention (0 week) and Post-intervention (13 week)

• Psychological Distress

  Pre-intervention (0 week) and Post-intervention (13 week)

• Patients' Quality of life

  Pre-intervention (0 week) and Post-intervention (13 week)

• Self-efficacy for Pain Management

  Pre-intervention (0 week) and Post-intervention (13 week)

Study Arms (2)

e-Lymph Control

ACTIVE COMPARATOR

e-Lymph (Control). e-Lymph includes training sessions on the lymphatic system, lymphedema, lymphedema diagnosis and measurement, risk of lymphedema.

Behavioral: The-Optimal-Lymph-Flow (TOLF) Program

The-Optimal-Lymph Flow (TOLF) Program

EXPERIMENTAL

TOLF includes training sessions on the lymphatic system, lymphedema, lymphedema diagnosis and measurement, risk of lymphedema, healthy diet, sleep hygiene, and daily lymphatic exercises. It has 8 avatar videos with step-by-step instructions for TOLF lymphatic exercises to promote lymph flow.

Behavioral: The-Optimal-Lymph-Flow (TOLF) Program

Interventions

The-Optimal-Lymph-Flow (TOLF) Program BEHAVIORAL

TOLF includes training sessions on the lymphatic system, lymphedema, lymphedema diagnosis and measurement, risk of lymphedema, healthy diet, sleep hygiene, and daily lymphatic exercises. It has 8 avatar videos with step-by-step instructions for TOLF lymphatic exercises to promote lymph flow. It is expected that participants will complete initial in-person or telehealth virtual 40-minute session, and 3 virtual telehealth sessions with each session for 20-minute over the course of 8 weeks.

The-Optimal-Lymph Flow (TOLF) Program; e-Lymph Control

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Missouri, Kansas City: lead

Study Sites (1)

University of Missouri-Kansas City

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain; Lymphedema; Behavior

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Mei R Fu

  University of Missouri, Kansas City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei R Fu, PhD

CONTACT

9739861758; mei.fu@umkc.edu

Christopher Winders

CONTACT

816-235-5370; windersc@umkc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will only know that they will be assigned to one of the two comparable behavioral and educational programs and they will not know which program is the intervention. Outcome assessors will not know the participants' assigned program throughout the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention and control arms

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 18, 2023
• Study Start: December 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)