EMPOWER 3: Improving Palliative Care Health Literacy and Utilization (EMPOWER 3)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer; Neoplasm Malignant
• Intervention / Treatment: Behavioral: Multimedia Psychoeducational Intervention; Behavioral: Enhanced Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 172
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimedia Psychoeducational Intervention + Enhanced Usual Care; Intervention participants receive the Multimedia Psychoeducational Intervention in addition to Enhanced Usual Care	Behavioral: 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; A video summary; A question prompt list patients can use to ask clinicians more questions about palliative care; Contact information and brochures for local palliative care programs; Behavioral: Enhanced Usual Care; 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)
Other: Enhanced Usual Care; Control participants receive Enhanced Usual Care	Behavioral: Enhanced Usual Care; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory: Brief COPE Inventory	Total score from 6-24 on 6 Brief COPE Inventory items measuring denial, acceptance (reverse-coded), and self-blame; higher scores indicate less effective coping	Follow-up at 14 days
Exploratory: PROMIS Anger	Total score from 2-10 on 2 items from the PROMIS Anger item bank; higher scores indicate more anger	Follow-up at 90 days
Exploratory: PROMIS Positive Affect	Total score from 2-10 on 2 items from the PROMIS Positive Affect item bank; higher scores indicate more positive affect	Follow-up at 90 days
Exploratory: PROMIS Stress	Total score from 4-20 on 4 items from the PROMIS Stress item bank; higher scores indicate more stress	Follow-up at 90 days
Exploratory: PROMIS General Self-Efficacy	Total score from 4-20 on 4 items from the PROMIS General Self-Efficacy item bank; higher scores indicate more stress	Follow-up at 90 days
Exploratory: Medication Adherence	Rating from 1-6 (Very poor to Excellent) for quality of medication adherence in the past 30 days; higher scores indicate better adherence	Follow-up at 90 days
Exploratory: PROMIS Emotional Support	Total score from 2-10 on 2 items from the PROMIS Emotional Support item bank; higher scores indicate more emotional support	Follow-up at 180 days
Exploratory: PROMIS Cognitive Function	Total score from 4-20 on 4 items from the PROMIS Cognitive Function item bank; higher scores indicate better cognitive function	Follow-up at 180 days
Exploratory: PROMIS Meaning and Purpose	Total score from 2-10 on 2 items from the PROMIS Meaning and Purpose item bank; higher scores indicate more meaning and purpose	Follow-up at 180 days
Exploratory: Quality of Life in Neurologic Disorders (Neuro-QoL) Concern with Death and Dying	Total score from 2-10 on 2 items from the Neuro-QoL Concern with Death and Dying item bank; ; higher scores indicate more concern	Follow-up at 180 days

Collaborators and Investigators

• Sponsor: Tulane University
• Collaborators: American Cancer Society, Inc.; University Medical Center-New Orleans
• Investigators: Principal Investigator: Michael Hoerger, PhD, MSCR, MBA, Tulane University

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 134579-RSG-20-058-01-PCSM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD can be shared with other researchers upon completing a data usage agreement signed by all participating universities.
• IPD Sharing Time Frame: By the study end date, available for at least 3 years.
• IPD Sharing Access Criteria: Contact the Study PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No