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

60 Participants Needed

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.

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.

How does the TOLF treatment differ from other treatments for breast cancer-related lymphedema?

The TOLF treatment is unique because it is a web- and mobile-based program that focuses on self-management strategies to activate the lymphatic system and promote lymph flow, using digital therapy with lymphatic and limb mobility exercises. It is designed to be patient-centered, safe, and easy to use, helping breast cancer survivors manage lymphedema symptoms effectively. ^{1 2 3 4 5}

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

References

1. Switzerland 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. [2022]

2. Canada 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. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Usability and feasibility of health IT interventions to enhance Self-Care for Lymphedema Symptom Management in breast cancer survivors. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Effects of Kinect-Enhanced Lymphatic Exercise Intervention on Lymphatic Pain, Swelling, and Lymph Fluid Level. [2021]

5. China pubmed.ncbi.nlm.nih.gov

mHealth self-care interventions: managing symptoms following breast cancer treatment. [2022]