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临床试验 NCT04733469 (EMPOWER 3) 针对癌症，恶性肿瘤目前进行中（不再招募）。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。
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EMPOWER 3: Improving Palliative Care Health Literacy and Utilization 172 随机化

进行中（不再招募）
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临床试验NCT04733469 (EMPOWER 3)是一项针对癌症，恶性肿瘤的干预性研究试验，目前试验状态为进行中（不再招募）。试验始于2021年3月31日，计划招募172名患者。该研究由杜蘭大學主导，预计于2026年8月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年2月2日。
简要概括
Through this award, Michael Hoerger, PhD, MSCR, a psychologist at the Tulane Cancer Center in Louisiana, will lead a study called EMPOWER 3 designed to test an educational intervention to help patients understand palliative care, use it, and feel better emotionally and physically. Participants will be adults with serious cancer diagnoses. Participants will be randomized into two groups. Patients in the control group ...显示更多
官方标题

EMPOWER 3: Improving Palliative Care Health Literacy and Utilization

疾病
癌症恶性肿瘤
其他研究标识符
  • EMPOWER 3
  • 134579-RSG-20-058-01-PCSM
NCT编号
NCT04733469
实际开始日期
2021-03-31
最近更新发布
2026-02-02
预计完成日期
2026-08-31
计划入组人数
172
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
进行中（不再招募）
主要目的
支持治疗
分配方式
随机
干预模型
平行
盲法
双盲
试验组/干预措施
参与者组/试验组干预措施/治疗方法
实验性Multimedia Psychoeducational Intervention + Enhanced Usual Care
Intervention participants receive the Multimedia Psychoeducational Intervention in addition to Enhanced Usual Care
Multimedia Psychoeducational Intervention
The Multimedia Psychoeducational Intervention includes a multimedia educational video plus additional resources to reinforce the video content. The Multimedia Psychoeducational Intervention includes the following: * A multimedia educational video about palliative care that is individually tailored to each patient's level of education and health literacy * Take-home and online copies of the video for repeat viewing *...显示更多
增强的常规护理
Enhanced Usual Care refers to usual care plus minor enhancement to improve quality and standardization. Enhanced Usual Care includes the following: * Usual care * A packet of flyers and handouts with general information on psychosocial oncology services derived from the American Society of Clinical Oncology (ASCO), Center to Advance Palliative Care (CAPC), and American Cancer Society (ACS)
其他Enhanced Usual Care
Control participants receive Enhanced Usual Care
增强的常规护理
Enhanced Usual Care refers to usual care plus minor enhancement to improve quality and standardization. Enhanced Usual Care includes the following: * Usual care * A packet of flyers and handouts with general information on psychosocial oncology services derived from the American Society of Clinical Oncology (ASCO), Center to Advance Palliative Care (CAPC), and American Cancer Society (ACS)
主要终点
结果指标度量标准描述时间框架
Aim 1: Palliative Care Knowledge Scale (PaCKS)
Percentage correct on 13 items; higher scores indicate greater knowledge
Post-test of Visit 1, typically day 1
次要终点
结果指标度量标准描述时间框架
Aim 2a: Palliative Care Attitudes Scale (PCAS-9)
Total score from 0-36; higher scores indicate more positive attitudes
Post-test of Visit 1, typically day 1
Aim 2b: Palliative Care Utilization
Utilization of palliative care (presence/absence)
Up to 90 days
Aim 3a: Patient-Reported Outcome Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions
Total score from 8-40 on 8 items from PROMIS self-efficacy for managing symptoms and self-efficacy for managing emotions items banks; higher scores indicate greater self-efficacy
Follow-up at 14, 90, and 180 days
Aim 3b: PROMIS Emotional Distress
Total score from 8-40 on 8 items from the PROMIS Depression and Anxiety item banks; higher scores indicate greater symptom severity
Follow-up at 14, 90, and 180 days
Aim 3c: Edmonton Symptom Assessment Scale (ESAS)-Physical
Total score from 0-60 on 6 ESAS ratings of pain, tiredness, drowsiness, nausea, poor appetite, and difficulty breathing; higher scores indicate greater symptom severity
Follow-up at 14, 90, and 180 days
参与助手
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部

  1. Adult, age 18 or older

  2. Meets criteria for 2a or 2b. 2a) The patient's doctor believes they may be appropriate for palliative cancer care OR 2b) The patient has a new diagnosis, recurrence, or progression of cancer in the past 90 days AND any of the following:

    • Advanced cancer, such as:

      • Lung Cancer: Stage IIIB or IV non-small cell, or extensive stage small cell

      • Breast Cancer: Stage IV

      • Gastrointestinal (GI) Cancers: Unresectable stage III or stage IV

      • Genitourinary (GU) Cancers: Stage IV

      • Melanoma: Stage IV

      • Hematologic Malignancies

        • Leukemia (e.g., acute myeloid leukemia \[AML\], acute lymphoblastic leukemia \[ALL\], chronic myeloid leukemia (CML), chronic lymphocytic leukemia \[CLL\]): advanced stage, treatment refractory, poor prognosis cell type or chromosomal abnormalities, older age
        • Lymphoma: Stage IV or treatment refractory Hodgkin's disease or non-Hodgkin's lymphoma Multiple Myeloma: elevated β2-microglobulin, albumin <3.5, PCLI >1%, CRP >6µg/mL, elevated LDH, plasmablastic morphology, or abnormal chromosome 13

    • Advanced heart, lung, renal (kidney), or liver disease

    • Two or more severe symptoms (≥7 on 0-10 scale): pain, tiredness, drowsiness, nausea, bad appetite, shortness of breath, depression, or anxiety

  3. Patient can understand spoken or written English

  4. Patient receives care in southeast Louisiana

  • Known history of receiving specialty palliative care or hospice
  • Significant psychiatric or other co-morbid disease that would prohibit informed consent or participation in the study
  • Unlikely to complete any follow-up surveys
Tulane University logo杜蘭大學
  • American Cancer Society, Inc. logoAmerican Cancer Society, Inc.
  • University Medical Center-New Orleans logoUniversity Medical Center-New Orleans
研究责任方
Michael Hoerger, PhD, MSCR, 主要研究者, Associate Professor of Psychology, Psychiatry, and Oncology, Tulane University
没有联系数据。
2 位于 1 个国家/地区的研究中心

Louisiana

University Medical Center, New Orleans, Louisiana, 70112, United States
Tulane University, New Orleans, Louisiana, 70115, United States