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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Mei Rosemary Fu, PhD
- Número de telefone: 9739861758
- E-mail: mei.fu@umkc.edu
Estude backup de contato
- Nome: Stephanie Korth, APRN
- Número de telefone: 8164040109
- E-mail: Stephanie.Korth@uhkc.org
Locais de estudo
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Missouri
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Kansas City, Missouri, Estados Unidos, 64108
- University of Missouri-Kansas City
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Contato:
- Mei Rosemary Fu, PhD
- Número de telefone: 9739861758
- E-mail: mei.fu@umkc.edu
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Lymphatic Pain
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Daily Living Function
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
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Outros números de identificação do estudo
- 2134300
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