EMPOWER 3: Improving Palliative Care Health Literacy and Utilization
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Aim 1: Palliative Care Knowledge Scale (PaCKS)
研究概览
简要总结
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 will get enhanced usual care, meaning standard cancer care and several additional healthcare-related brochures. Patients in the intervention group will get enhanced usual care plus an educational video developed by the investigators and other materials designed to increase understanding and use of palliative care. Family members of patients in the intervention group may also attend if desired. The investigators will track participants' understanding of palliative care, attitudes toward palliative care, symptoms over 6 months of follow-up, and palliative care utilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, age 18 or older
- •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
- •Patient can understand spoken or written English
- •Patient receives care in southeast Louisiana
排除标准
- •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
研究组 & 干预措施
Multimedia Psychoeducational Intervention + Enhanced Usual Care
Intervention participants receive the Multimedia Psychoeducational Intervention in addition to Enhanced Usual Care
干预措施: Multimedia Psychoeducational Intervention (Behavioral)
Multimedia Psychoeducational Intervention + Enhanced Usual Care
Intervention participants receive the Multimedia Psychoeducational Intervention in addition to Enhanced Usual Care
干预措施: Enhanced Usual Care (Behavioral)
Enhanced Usual Care
Control participants receive Enhanced Usual Care
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Aim 1: Palliative Care Knowledge Scale (PaCKS)
时间窗: Post-test of Visit 1, typically day 1
Percentage correct on 13 items; higher scores indicate greater knowledge
次要结局
- Aim 2b: Palliative Care Utilization(Up to 90 days)
- Aim 3c: Edmonton Symptom Assessment Scale (ESAS)-Physical(Follow-up at 14, 90, and 180 days)
- Aim 2a: Palliative Care Attitudes Scale (PCAS-9)(Post-test of Visit 1, typically day 1)
- Aim 3a: Patient-Reported Outcome Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions(Follow-up at 14, 90, and 180 days)
- Aim 3b: PROMIS Emotional Distress(Follow-up at 14, 90, and 180 days)
研究者
Michael Hoerger, PhD, MSCR
Associate Professor of Psychology, Psychiatry, and Oncology
Tulane University