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Advancing Patient Care for Lymphatic Pain and Lymphedema

Advancing Patient Care for Lymphatic Pain and Lymphedema

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07701018
Enrollment
35
Registered
2026-07-14
Start date
2026-07-01
Completion date
2027-12-31
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Lymphedema Arm, Pain

Keywords

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

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.

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.

Interventions

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.

Sponsors

University of Missouri, Kansas City
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

No masking

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Lymphatic PainPre-intervention and 12 weeks post-interventionThe 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).
Pain Severity and InterferencePre-intervention and 12 weeks post-interventionPain Severity and Interference: are measured using the Brief Pain Inventory-Short Form (BPI-SF) with demonstrated reliability and validity.

Secondary

MeasureTime frameDescription
Daily Living FunctionPre-intervention and 12 weeks post-interventionDaily 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.
Psychological DistresPre-intervention and 12 weeks post-interventionPsychological 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.
Self-perception of Quality of lifePre-intervention and 12 weeks post-interventionSelf-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).
Self-efficacy for Pain ManagementPre-intervention and 12 weeks post-interventionThe 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.

Countries

United States

Contacts

CONTACTMei Rosemary Fu, PhD
mei.fu@umkc.edu9739861758
CONTACTStephanie Korth, APRN
Stephanie.Korth@uhkc.org8164040109
PRINCIPAL_INVESTIGATORMei Rosemary Fu, PhD

University of Missouri, Kansas City

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026