Advancing Patient Care for Lymphatic Pain and Lymphedema
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Missouri, Kansas City
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
The-Optimal-Lymph-Flow
BehavioralThe-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.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: The-Optimal-Lymph-FlowExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Pre-intervention and 12 weeks post-intervention2
Pain Severity and Interference
Pain Severity and Interference: are measured using the Brief Pain Inventory-Short Form (BPI-SF) with demonstrated reliability and validity.
Time frame
Pre-intervention and 12 weeks post-interventionSecondary outcomes
1
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.
Time frame
Pre-intervention and 12 weeks post-intervention2
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.
Time frame
Pre-intervention and 12 weeks post-intervention3
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).
Time frame
Pre-intervention and 12 weeks post-intervention4
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.
Time frame
Pre-intervention and 12 weeks post-interventionSponsors and contacts
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Source ClinicalTrials.gov
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