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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Mei Rosemary Fu, PhD
- 電話番号：9739861758
- メール：mei.fu@umkc.edu
研究連絡先のバックアップ
- 名前：Stephanie Korth, APRN
- 電話番号：8164040109
- メール：Stephanie.Korth@uhkc.org
研究場所
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Missouri
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Kansas City、Missouri、アメリカ、64108
- University of Missouri-Kansas City
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コンタクト：
- Mei Rosemary Fu, PhD
- 電話番号：9739861758
- メール：mei.fu@umkc.edu
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Lymphatic Pain
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Daily Living Function
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Mei Rosemary Fu, PhD、University of Missouri, Kansas City
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2134300
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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