Advancing Patient Care for Lymphatic Pain and Lymphedema

Lymphatic pain refers to various pain sensations (e.g., pain, aching, soreness, tenderness, burning, stabbing) following breast cancer treatment. Lymphatic pain affects more than half of 4 million patients treated for breast cancer in the United States. Lymphatic pain significantly impairs patients' daily living function, increases psychological distress, and decreases quality of life. As a significant risk of lymphedema, lymphatic pain indicates an early stage of lymphedema. Lymphedema is a chronic and incurable swelling caused by an abnormal fluid build-up following breast cancer treatment. Without timely intervention in this early stage, lymphedema can progress into a chronic condition that no surgical or medical interventions can cure.

The purpose of the project is to adapt The-Optimal-Lymph-Flow (TOLF) in clinical practice. A digital lymphatic pain and lymphedema assessment will be implemented in clinical practice, conduct clinician training and deliver TOLF Self-Care interventions to patients with lymphatic pain.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Breast Cancer; Lymphedema Arm
• Intervention / Treatment: Behavioral: The-Optimal-Lymph-Flow

Detailed Description

Patients with financial hardship are 4.64 times more likely to report lymphatic pain. Further, obesity/high body mass index is an important risk factors for lymphatic pain and lymphedema. Effective management of lymphatic pain can decrease the risk of lymphedema and reverse mild lymphedema as well as improve daily living functions, psychological distress, and quality of life. The-Optimal-Lymph-Flow (TOLF) is a non-pharmacological and digital behavioral intervention that builds patients' self-care skills to promote lymph flow and result in complete pain reduction, reduced lymph fluid level, reversed mild lymphedema, improved psychological distress and quality of life. Of concern, this effective intervention has not been adapted to reduce patient barriers (e.g., available care, cost, time, travel, competing demands) and health system barriers (e.g., intervention availability, staffing, therapist) to timely interventions faced by patients, especially those with financial hardship.

The purpose of the project is to adapt The-Optimal-Lymph-Flow (TOLF) in clinical practice. A digital lymphatic pain and lymphedema assessment will be implemented in clinical practice, conduct clinician training and deliver TOLF Self-Care interventions to patients with lymphatic pain at Richard & Annette Block Cancer Center at University Health Kansas City. The objectives of the study are: 1) Conduct a pragmatic clinical implementation study with 100 patients to evaluate implementation effectiveness of lymphatic pain assessment; 3) Conduct a pragmatic, one-group, 12-week clinical trial with 35 patients with lymphatic pain to evaluate real-world clinical effectiveness of TOLF Self-Care intervention.

The project has potential to have major impact on advancing patient care for lymphatic pain and lymphedema, especially in patients with financial hardship. The project will showcase the way of how to build clinical capacity to provide quality care for patients with lymphatic pain and lymphedema in health systems across the nation.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mei Rosemary Fu, PhD; Phone Number: 9739861758; Email: mei.fu@umkc.edu
• Study Contact Backup: Name: Stephanie Korth, APRN; Phone Number: 8164040109; Email: Stephanie.Korth@uhkc.org

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • University of Missouri-Kansas City
      • Contact: Mei Rosemary Fu, PhD; Phone Number: 9739861758; Email: mei.fu@umkc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Inclusion criteria for patient participants are a) Patients over age 18 who received surgical treatment for breast cancer at least 3 months prior to the study enrollment; b) Patients reported lymphatic pain; c) Patients who are able to understand the study protocols presented in English language.

Exclusion Criteria:

Exclusion criteria include a) presence of a serious psychiatric condition (e.g., schizophrenia, suicidal intent) indicated by medical chart, treating oncologist or other staff, or study staff interactions that would contraindicate safe study participation; b) known metastatic disease (Stage IV), recurrence of cancer, or lymphedema due to cancer recurrence, or cancer in the thoracic or cervical regions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The-Optimal-Lymph-Flow; The-Optimal-Lymph-Flow (TOLF Self-Care) is a non-pharmacological and digital behavioral intervention that builds patients' self-care skills to promote lymph flow that leads to complete pain reduction, reduced lymph fluid level, reversed mild lymphedema, and improved quality of life.	Behavioral: The-Optimal-Lymph-Flow; The-Optimal-Lymph-Flow (TOLF Self-Care) is a non-pharmacological and digital behavioral intervention that builds patients' self-care skills to promote lymph flow that leads to complete pain reduction, reduced lymph fluid level, reversed mild lymphedema, and improved quality of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lymphatic Pain	The Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part I, a reliable and valid self-report instrument is used to assess self-reported lymphatic pain. The items are rated on a Likert scale from 0 (no lymphatic pain/swelling) to 4 (greatest severity of lymphatic pain/swelling).	Pre-intervention and 12 weeks post-intervention
Pain Severity and Interference	Pain Severity and Interference: are measured using the Brief Pain Inventory-Short Form (BPI-SF) with demonstrated reliability and validity.	Pre-intervention and 12 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Living Function	Daily living function is operationalized as Activities of Daily Living (ADLs) that reflect the real-world daily living of breast cancer patients. The 13-item subscale of ADLs in BCLE-SEI Part II is used to assess self-reported difficulty in performing thirteen ADLs.	Pre-intervention and 12 weeks post-intervention
Psychological Distres	Psychological Distress: The 12-item subscale of psychological/emotional distress subscale from the BCLE-SEI Part II is used to assess the distress of being frustrated, sad, guilt/self-blame, worried, irritable, fearful, angry, lonely, helpless, hopeless, anxious, and depressed.	Pre-intervention and 12 weeks post-intervention
Self-perception of Quality of life	Self-perception pf Quality of Life: is measured by The 10-item V1.2 Patient Reported Outcome Measure Information System Global Health Scale (PROMIS GHS). Self-perception of quality of life is measured on a scale from 1 (poor), 2 (fair), 3 (good), 4 (very good) to 5 (excellent).	Pre-intervention and 12 weeks post-intervention
Self-efficacy for Pain Management	The 5-item Chronic Pain Self-Efficacy Scale with good reliability is used to assess patients' certainty about their degree of pain control, pain during daily activities, controlling pain during sleep, and making pain reductions without extra medication.	Pre-intervention and 12 weeks post-intervention

Collaborators and Investigators

• Sponsor: University of Missouri, Kansas City
• Investigators: Principal Investigator: Mei Rosemary Fu, PhD, University of Missouri, Kansas City

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; pain; lymphedema; Lymphatic pain; The-Optimal-Lymph-Flow; lymphedema symptoms
• Additional Relevant MeSH Terms: Neurologic Manifestations; Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Lymphatic Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Hemic and Lymphatic Diseases; Pain; Breast Neoplasms; Lymphedema
• Other Study ID Numbers: 2134300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will not share the individual patient data. However, upon reasonable request, de-identified and aggregated data may be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No