Trial Title:
Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women With Breast Cancer
NCT ID:
NCT06133959
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Lymphedema
Conditions: Keywords:
pain
lymphedema
breast cancer
behavior
intervention
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Intervention and control arms
Primary purpose:
Supportive Care
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
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.
Intervention:
Intervention type:
Behavioral
Intervention name:
The-Optimal-Lymph-Flow (TOLF) Program
Description:
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.
Arm group label:
The-Optimal-Lymph Flow (TOLF) Program
Arm group label:
e-Lymph Control
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.
Criteria for 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.
Exclusion Criteria:
- 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
89 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Missouri-Kansas City
Address:
City:
Kansas City
Zip:
64108
Country:
United States
Contact:
Last name:
Mei R Fu, PhD
Phone:
973-986-1758
Email:
mei.fu@umkc.edu
Contact backup:
Last name:
Cynthia Russel Lippincott, PhD
Phone:
816-235-2661
Email:
russellc@umkc.edu
Start date:
December 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
University of Missouri, Kansas City
Agency class:
Other
Source:
University of Missouri, Kansas City
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06133959
