Advancing Patient Care for Lymphatic Pain and Lymphedema

NCT07701018 | Not Yet Recruiting

• 1 other identifier: 2134300
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Pain; Lymphedema Arm

Keywords

Lymphatic pain; lymphedema; The-Optimal-Lymph-Flow; breast cancer; pain; lymphedema symptoms

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Daily Living Function

  Pre-intervention and 12 weeks post-intervention

• Psychological Distres

  Pre-intervention and 12 weeks post-intervention

• Self-perception of Quality of life

  Pre-intervention and 12 weeks post-intervention

• Self-efficacy for Pain Management

  Pre-intervention and 12 weeks post-intervention

Study Arms (1)

The-Optimal-Lymph-Flow

EXPERIMENTAL

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

Interventions

The-Optimal-Lymph-Flow BEHAVIORAL

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.

The-Optimal-Lymph-Flow

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Missouri, Kansas City: lead

Study Sites (1)

University of Missouri-Kansas City

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Mei Rosemary Fu, PhD

  University of Missouri, Kansas City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei Rosemary Fu, PhD

CONTACT

9739861758; mei.fu@umkc.edu

Stephanie Korth, APRN

CONTACT

8164040109; Stephanie.Korth@uhkc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: July 14, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)