TOLF Program for Breast Cancer
(HealthyME Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMei R Fu

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Missouri, Kansas City

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Mei R Fu

Principal Investigator

University of Missouri, Kansas City

Eligibility Criteria

This trial is for Black and Hispanic women over 18 who have had breast cancer surgery at least 3 months ago, experience lymphatic pain but haven't been treated for lymphedema. They must self-identify as Black or Hispanic, understand English, and not have serious psychiatric conditions, Stage IV cancer, recurrence of cancer or other diseases in the thoracic/cervical regions.

Inclusion Criteria

I experience ongoing pain or discomfort in the same side of my body or arm.

I had breast cancer surgery at least 3 months ago.

Self-identify as either Black or Hispanic

See 3 more

Exclusion Criteria

I have been diagnosed or treated for lymphedema.

You have a serious mental health condition that could make it unsafe for you to take part in the study.

My cancer has spread to other parts of my body or returned after treatment.

Treatment Details

Interventions

The-Optimal-Lymph-Flow (TOLF) Program (Behavioural Intervention)

Trial OverviewThe study tests a culturally adapted behavioral intervention called The-Optimal-Lymph-Flow (TOLF) against standard lymphedema education to see if it can reduce pain and improve quality of life in participants. It involves focus groups for adaptation followed by a randomized controlled trial to assess its effectiveness.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: The-Optimal-Lymph Flow (TOLF) ProgramExperimental Treatment1 Intervention

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 II: e-Lymph ControlActive Control1 Intervention

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