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

January 29, 2026 updated by: Michael Hoerger, PhD, MSCR, Tulane University
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Aim 1: Palliative Care Knowledge Scale (PaCKS)
Time Frame: Post-test of Visit 1, typically day 1
Percentage correct on 13 items; higher scores indicate greater knowledge
Post-test of Visit 1, typically day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Aim 2a: Palliative Care Attitudes Scale (PCAS-9)
Time Frame: Post-test of Visit 1, typically day 1
Total score from 0-36; higher scores indicate more positive attitudes
Post-test of Visit 1, typically day 1
Aim 2b: Palliative Care Utilization
Time Frame: Up to 90 days
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
Time Frame: 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
Follow-up at 14, 90, and 180 days
Aim 3b: PROMIS Emotional Distress
Time Frame: 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
Follow-up at 14, 90, and 180 days
Aim 3c: Edmonton Symptom Assessment Scale (ESAS)-Physical
Time Frame: 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
Follow-up at 14, 90, and 180 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exploratory: Brief COPE Inventory
Time Frame: Follow-up at 14 days
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
Time Frame: Follow-up at 90 days
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
Time Frame: Follow-up at 90 days
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
Time Frame: Follow-up at 90 days
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
Time Frame: Follow-up at 90 days
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
Time Frame: Follow-up at 90 days
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
Time Frame: Follow-up at 180 days
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
Time Frame: Follow-up at 180 days
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
Time Frame: Follow-up at 180 days
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
Time Frame: Follow-up at 180 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tulane University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Cancer Society, Inc.
University Medical Center-New Orleans

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Hoerger, PhD, MSCR, MBA, Tulane University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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