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CancerEMPOWER 3NCT04733469

EMPOWER 3: Improving Palliative Care Health Literacy and Utilization

A study testing Multimedia Psychoeducational Intervention in people with Cancer and Neoplasm Malignant, run by Tulane University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Neoplasm Malignant
What is being tested?
Multimedia Psychoeducational Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
2 sitesUnited States
Study dates
31 Mar 2021to 31 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University Medical Center

    New Orleans, Louisiana, 70112

  • Tulane University

    New Orleans, Louisiana, 70115

Other trials in United States

About this study

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.

Being tested
Multimedia Psychoeducational Intervention, Enhanced Usual Care
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multimedia Psychoeducational InterventionBehavioural

    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

  • Enhanced Usual CareBehavioural

    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)
Study groups in NCT04733469
Study groupRoleWhat they receive
Multimedia Psychoeducational Intervention + Enhanced Usual CareExperimentalIntervention participants receive the Multimedia Psychoeducational Intervention in addition to Enhanced Usual Care
Receives: Behavioral: Multimedia Psychoeducational Intervention; Behavioral: Enhanced Usual Care
Enhanced Usual CareOtherControl participants receive Enhanced Usual Care
Receives: Behavioral: Enhanced Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aim 1: Palliative Care Knowledge Scale (PaCKS)

    Percentage correct on 13 items; higher scores indicate greater knowledge

    Measured: Post-test of Visit 1, typically day 1

Secondary outcomes (5)

  1. Aim 2a: Palliative Care Attitudes Scale (PCAS-9)

    Total score from 0-36; higher scores indicate more positive attitudes

    Measured: Post-test of Visit 1, typically day 1

  2. Aim 2b: Palliative Care Utilization

    Utilization of palliative care (presence/absence)

    Measured: Up to 90 days

  3. 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

    Measured: Follow-up at 14, 90, and 180 days

  4. 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

    Measured: Follow-up at 14, 90, and 180 days

  5. 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

    Measured: Follow-up at 14, 90, and 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2021
  2. Study start31 Mar 2021
  3. Primary completion10 Oct 2025
  4. Study completion31 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04733469
Sponsor's protocol ID
134579-RSG-20-058-01-PCSM
Acronym
EMPOWER 3
Status last verified
Oct 2026
First submitted
25 Jan 2021
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD can be shared with other researchers upon completing a data usage agreement signed by all participating universities.

Questions about this trial

What is this clinical trial studying?

A study testing Multimedia Psychoeducational Intervention in people with Cancer and Neoplasm Malignant, run by Tulane University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aim 1: Palliative Care Knowledge Scale (PaCKS) (time frame: Post-test of Visit 1, typically day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04733469.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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