EMPOWER 3: Improving Palliative Care Health Literacy and Utilization

Not Applicable

Recruiting

• Conditions: Cancer; Neoplasm Malignant
• Interventions: Behavioral: Multimedia Psychoeducational Intervention; Behavioral: Enhanced Usual Care

• Registration Number: NCT04733469
• Lead Sponsor: Tulane University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-02-02
• Study Start: 2021-03-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-18
• Primary Completion: 2025-04
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimedia Psychoeducational Intervention + Enhanced Usual Care	Multimedia Psychoeducational Intervention	Intervention participants receive the Multimedia Psychoeducational Intervention in addition to Enhanced Usual Care
Multimedia Psychoeducational Intervention + Enhanced Usual Care	Enhanced Usual Care	Intervention participants receive the Multimedia Psychoeducational Intervention in addition to Enhanced Usual Care
Enhanced Usual Care	Enhanced Usual Care	Control participants receive Enhanced Usual Care

Primary Outcome Measures

Name	Time	Method
Aim 1: Palliative Care Knowledge Scale (PaCKS)	Post-test of Visit 1, typically day 1	Percentage correct on 13 items; higher scores indicate greater knowledge

Secondary Outcome Measures

Name	Time	Method
Aim 2b: Palliative Care Utilization	Up to 90 days	Utilization of palliative care (presence/absence)
Aim 3c: Edmonton Symptom Assessment Scale (ESAS)-Physical	Follow-up at 14, 90, and 180 days	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
Aim 2a: Palliative Care Attitudes Scale (PCAS-9)	Post-test of Visit 1, typically day 1	Total score from 0-36; higher scores indicate more positive attitudes
Aim 3a: Patient-Reported Outcome Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions	Follow-up at 14, 90, and 180 days	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
Aim 3b: PROMIS Emotional Distress	Follow-up at 14, 90, and 180 days	Total score from 8-40 on 8 items from the PROMIS Depression and Anxiety item banks; higher scores indicate greater symptom severity

Trial Locations

Locations (2)

University Medical Center; 🇺🇸 New Orleans, Louisiana, United States

Tulane University; 🇺🇸 New Orleans, Louisiana, United States