TOLF Program for Breast Cancer

(HealthyME Trial)

Overseen By Christopher Winders

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Missouri, Kansas City

Disqualifiers: Serious psychiatric condition, metastatic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called The-Optimal-Lymph-Flow (TOLF) to help Black and Hispanic women manage lymphatic pain after breast cancer treatment. The goal is to make TOLF culturally appropriate and determine if it can reduce pain, improve lymph flow, and enhance quality of life. Participants will either engage in the TOLF program, which includes exercises and wellness tips, or attend educational sessions about lymphedema, the swelling caused by lymph fluid buildup. Women who have undergone breast cancer surgery and experience ongoing pain or soreness might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to culturally tailored healthcare solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the TOLF Program is safe for Black and Hispanic patients?

In a previous study, the TOLF program showed promising results for people with lymphedema, a condition characterized by swelling from lymph fluid. Participants experienced reduced pain and swelling after using TOLF. The program emphasizes exercises and lifestyle changes to facilitate lymph fluid movement through the body.

Research has shown that TOLF is well-tolerated. Participants reported no major side effects and generally felt better after the program, with improvements in pain and quality of life. This suggests the program is safe for people to try. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TOLF Program because it goes beyond traditional treatments for lymphedema associated with breast cancer. Unlike standard care options, which often focus on managing symptoms through compression garments and physical therapy, TOLF integrates a holistic approach that includes training on lymphatic health, exercise, diet, and sleep hygiene. The program features eight interactive avatar videos that guide patients through exercises to promote optimal lymph flow, potentially reducing the risk of lymphedema. This comprehensive strategy aims to empower patients with tools to actively manage their lymphatic health, offering a proactive rather than reactive approach to treatment.

What evidence suggests that the TOLF Program is effective for breast cancer-related lymphedema?

Research has shown that The-Optimal-Lymph-Flow (TOLF) program, which participants in this trial may receive, can significantly aid breast cancer survivors in managing lymphedema. Studies have found that TOLF users experience less lymphatic pain, reduced fluid buildup, and improvement in mild lymphedema. Participants also reported a better quality of life and increased confidence in managing their condition. Data from earlier trials indicated that TOLF users benefited more than those who did not use the program. This suggests that TOLF could effectively reduce symptoms and enhance daily life for those with lymphedema after breast cancer. ^{1 3 4 6 7}

Who Is on the Research Team?

Mei R Fu

Principal Investigator

University of Missouri, Kansas City

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Adaptation Phase

Focus groups are conducted to adapt the TOLF intervention to be culturally appropriate for Black and Hispanic women.

4 weeks

Multiple focus group sessions

Treatment

Participants are randomized to either the TOLF program or e-Lymph education, with training sessions on lymphatic system management.

13 weeks

Regular sessions (in-person and virtual)

Follow-up

Participants are monitored for primary and secondary outcomes such as lymphatic pain, psychological distress, and quality of life.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• The-Optimal-Lymph-Flow (TOLF) Program

Trial Overview

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.

How Is the Trial Designed?

Group I: The-Optimal-Lymph Flow (TOLF) Program Experimental Treatment 1 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 Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Missouri, Kansas City

Lead Sponsor

Trials

73

Recruited

34,600+

Published Research Related to This Trial

The Optimal Lymph Flow (TOLF) system significantly reduced chronic pain and soreness in breast cancer survivors compared to the arm precaution (AP) control group, with 50% of TOLF participants achieving complete pain reduction.

TOLF also led to improvements in symptoms like arm/hand swelling and limited movement, while reducing the need for pain medications by 13%, indicating its effectiveness in managing lymphedema-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Results of a Randomized Clinical Trial. Fu, MR., Axelrod, D., Guth, AA., et al.[2023]

The Optimal Lymph Flow (TOLF) health IT system was highly accepted by breast cancer survivors, with 90% reporting no usability issues and 96.6% finding it easy to use and effective for learning about lymphedema management.

Qualitative feedback highlighted themes of empowerment and accessibility, indicating that TOLF successfully provides high-quality information and user-friendly features to support self-care strategies for lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and feasibility of health IT interventions to enhance Self-Care for Lymphedema Symptom Management in breast cancer survivors. Fu, MR., Axelrod, D., Guth, AA., et al.[2022]

The Optimal-Lymph-Flow (TOLF) program significantly improved lymphedema symptoms, including the number and severity of symptoms, as well as their impact on daily activities, in breast cancer survivors compared to a control group.

Patients in the TOLF group had a lower incidence of significant arm volume differences (≥5%) at the study's end, indicating better management of lymphedema and suggesting that TOLF could be an effective early intervention in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies in activating lymphatic system to promote lymph flow on lymphedema symptoms in breast cancer survivors: A randomized controlled trial. Du, X., Li, Y., Fu, L., et al.[2022]

The Kinect-TOLF intervention significantly reduced lymphatic pain, swelling, and lymphedema symptoms in 30 breast cancer survivors, demonstrating its effectiveness in managing these issues after just one training session.

Participants reported high satisfaction with the Kinect-TOLF program, which not only improved their symptoms but also effectively taught them the correct lymphatic exercises, indicating its feasibility and safety for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Kinect-Enhanced Lymphatic Exercise Intervention on Lymphatic Pain, Swelling, and Lymph Fluid Level. Fu, MR., McTernan, ML., Qiu, JM., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10294092/

Data on the effects of The-Optimal-Lymph-Flow program on ...

Outcome data were collected at baseline and three months after intervention. Study outcomes included lymphedema symptom experience (i.e., number, severity, ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37383767/

Data on the effects of The-Optimal-Lymph-Flow program on ...

The dataset presented in this article was obtained from a randomized clinical trial (RCT) that assessed the preventive effects of the TOLF ...

3.

frontiersin.org

frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.1015387/full

Strategies in activating lymphatic system to promote lymph ...

Patients in both groups showed improvements in all study outcomes over the 3 months, whereas those in the TOLF group gained greater benefits in ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06133959

Healthy ME: Advancing Health Equity in Lymphatic Pain and ...

The investigators have developed and tested behavioral intervention program TOLF that builds patients' self-management skills to promote lymph flow and results ...

5.

researchgate.net

researchgate.net/publication/371122939_Data_on_the_effects_of_The-Optimal-Lymph-Flow_program_on_lymphedema_symptoms_in_breast_cancer_survivors

(PDF) Data on the effects of The-Optimal-Lymph-Flow ...

Conclusions Findings of the study demonstrated positive outcomes of relieving lymphedema symptom experience, optimizing arm circumference and ...

6.

hsrc.himmelfarb.gwu.edu

hsrc.himmelfarb.gwu.edu/gwhpubs/2769/

"Data on the effects of The-Optimal-Lymph-Flow program on ...

The dataset presented in this article was obtained from a randomized clinical trial (RCT) that assessed the preventive effects of the TOLF ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39177930/

The effects of the-optimal-lymph-flow health IT system ...

Conclusions: The application of TOLF in patients at high risk of developing lymphedema following breast cancer treatment significantly improved the lymphedema- ...