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Behavioural Intervention

TOLF Program for Breast Cancer (HealthyME Trial)

N/A

Waitlist Available

Led By Mei R Fu

Research Sponsored by University of Missouri, Kansas City

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to understand the study protocols presented in English

Black and Hispanic women (over age 18) with lymphatic pain following breast cancer treatment

Must not have

Diagnosed or treated for lymphedema

Known metastatic disease (Stage IV), recurrence of cancer, or lymphedema due to cancer recurrence, or other bulk disease in the thoracic or cervical regions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-intervention (0 week) and post-intervention (13 week)

Awards & highlights

No Placebo-Only Group

Summary

This trial will adapt and test a behavioral intervention for Black and Hispanic women with lymphatic diseases to reduce pain, improve quality of life, and reduce fluid levels.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Since TOLF is a behavioral program focusing on self-management skills rather than medication or invasive procedures, significant side effects are not expected. However, any discomfort from discussing personal experiences during focus groups or changes in routine due to new practices may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand English and can follow study instructions.

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I am a Black or Hispanic woman over 18 with lymphatic pain after breast cancer treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed or treated for lymphedema.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-intervention (0 week) and post-intervention (13 week)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-intervention (0 week) and post-intervention (13 week)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-intervention (0 week) and post-intervention (13 week) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lymphatic Pain

Pain Severity and Interference

Secondary study objectives

Daily Living Function

Lymph Fluid Level

Patients' Quality of life

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 4Eligibility criteria met