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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

HealthyME Trial 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.Check my eligibility

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.See study design

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.

HealthyME Trial 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.

HealthyME Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Lymphatic Pain

Pain Severity and Interference

Secondary outcome measures

Daily Living Function

Lymph Fluid Level

Patients' Quality of life

+2 more

HealthyME 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Missouri, Kansas CityLead Sponsor

69 Previous Clinical Trials

32,584 Total Patients Enrolled

1 Trials studying Breast Cancer

130 Patients Enrolled for Breast Cancer

Mei R FuPrincipal InvestigatorUniversity of Missouri, Kansas City

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to join the research process of this clinical trial?

"Eligibility criteria for this trial is restricted to individuals with a diagnosis of breast cancer who are between 18 and 89 years old. In total, 60 participants will be enrolled in the study."

Answered by AI

Is enrollment restricted to individuals under 45 or may those older be accepted into the trial?

"This medical trial is enrolling individuals aged 18 and up, but not more than 89 years old."

Answered by AI

What are the main goals of this clinical experiment?

"This trial will assess Pain Severity and Interference over a pre-intervention (0 week) to post-intervention (13 week) duration. Secondary objectives include measuring Daily Living Function through the Breast cancer and Lymphedema Symptom Experience Index, Psychological Distress via a 12 item subscale of emotional distress, as well as Patients' Quality of Life by way of the Global Health Scale PROMIS tool."

Answered by AI

Does this clinical investigation have any open enrollment spots?

"Based on the details available from clinicaltrials.gov, this medical trial is not presently open for recruitment. Initially posted in December 1st of 2023 and last updated November 10th of 2023, it is no longer looking to enroll participants; however, there are currently 2501 other trials actively seeking patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06133959.

All > Breast Cancer Hawaii > Lymphedema