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

NCT ID: NCT06133959

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-12-31

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.

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 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.

RATIONALE/SIGNIFICANCE OF THE STUDY. Lymphatic pain refers to pain, aching or soreness in the ipsilateral body or upper limb following breast cancer treatment. More than half of the 3.8 million women with breast cancer suffer lymphatic pain which leads to impaired daily living function, psychological distress, and compromised QOL. Most importantly, lymphatic pain is significantly associated with lymphedema, a chronic and incurable condition caused by an abnormal accumulation of lymph fluid. Black and Hispanic women are three times as likely to suffer from lymphedema compared to White women. Timely intervention for lymphatic pain can decrease the risk and severity of lymphedema. However, there are persistent barriers to timely interventions faced by Black and Hispanic women with breast cancer - a group at high risk for developing lymphedema, pain, and other negative breast cancer related outcomes.

THEORETICAL FRAMEWORK. Self-efficacy theory guides the project. Behavioral pain interventions focus on training patients on self-management skills to be implemented in their daily lives.

MAIN RESEARCH VARIABLES. Behavioral pain intervention (IV), Outcomes (DVs): lymphatic pain, pain severity and interference, lymph fluid level, daily living function, psychological distress, QOL, self-efficacy for pain management.

DESIGN. Qualitative and randomized clinical trial (RCT)

SETTING. All participants will be recruited from UMKC University Health and surrounding communities.

SAMPLES. Black and Hispanic women with lymphatic pain

METHODS. Focus groups will be conducted with Black and Hispanic women to gather data that will lead to culturally appropriate adaptation of TOLF. Then, a pilot RCT will be used to examine feasibility, acceptability, and evidence of future efficacy of this culturally adapted intervention.

IMPLICATIONS FOR PRACTICE. The successful completion of the project will advance health equity in pain and lymphedema by making this culturally appropriate, highly accessible, and effective behavioral intervention available to Black and Hispanic women.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

e-Lymph Control

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

Group Type: ACTIVE_COMPARATOR

The-Optimal-Lymph-Flow (TOLF) Program

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

The-Optimal-Lymph-Flow (TOLF) Program

Intervention Type: 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.

Interventions

The-Optimal-Lymph-Flow (TOLF) Program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri, Kansas City

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mei R Fu

Role: PRINCIPAL_INVESTIGATOR

University of Missouri, Kansas City

Locations

University of Missouri-Kansas City

Kansas City, Missouri, United States

Countries

United States

Central Contacts

Mei R Fu, PhD

Role: CONTACT

mei.fu@umkc.edu

9739861758

Christopher Winders

Role: CONTACT

windersc@umkc.edu

816-235-5370

Facility Contacts

Mei R Fu, PhD

Role: primary

mei.fu@umkc.edu

973-986-1758

Cynthia Russel Lippincott, PhD

Role: backup

russellc@umkc.edu

816-235-2661

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RE33

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2098673

Identifier Type: -

Identifier Source: org_study_id