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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mei Rosemary Fu, PhD
- Número de teléfono: 9739861758
- Correo electrónico: mei.fu@umkc.edu
Copia de seguridad de contactos de estudio
- Nombre: Stephanie Korth, APRN
- Número de teléfono: 8164040109
- Correo electrónico: Stephanie.Korth@uhkc.org
Ubicaciones de estudio
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Missouri
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Kansas City, Missouri, Estados Unidos, 64108
- University of Missouri-Kansas City
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Contacto:
- Mei Rosemary Fu, PhD
- Número de teléfono: 9739861758
- Correo electrónico: mei.fu@umkc.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Lymphatic Pain
Periodo de tiempo: Pre-intervention and 12 weeks post-intervention
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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).
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Pre-intervention and 12 weeks post-intervention
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Pain Severity and Interference
Periodo de tiempo: Pre-intervention and 12 weeks post-intervention
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Pain Severity and Interference: are measured using the Brief Pain Inventory-Short Form (BPI-SF) with demonstrated reliability and validity.
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Pre-intervention and 12 weeks post-intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Daily Living Function
Periodo de tiempo: Pre-intervention and 12 weeks post-intervention
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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.
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Pre-intervention and 12 weeks post-intervention
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Psychological Distres
Periodo de tiempo: Pre-intervention and 12 weeks post-intervention
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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.
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Pre-intervention and 12 weeks post-intervention
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Self-perception of Quality of life
Periodo de tiempo: Pre-intervention and 12 weeks post-intervention
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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).
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Pre-intervention and 12 weeks post-intervention
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Self-efficacy for Pain Management
Periodo de tiempo: Pre-intervention and 12 weeks post-intervention
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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.
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Pre-intervention and 12 weeks post-intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mei Rosemary Fu, PhD, University of Missouri, Kansas City
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Neoplasias por sitio
- Neoplasias
- Enfermedades de la piel
- Enfermedades de los senos
- Enfermedades linfáticas
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades de la piel y del tejido conectivo
- Signos y síntomas
- Enfermedades hemic y linfáticas
- Dolor
- Neoplasias de mama
- Linfedema
Otros números de identificación del estudio
- 2134300
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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