EMPOWER 3: Improving Palliative Care Health Literacy and Utilization

NCT04733469 | Active Not Recruiting

• 1 other identifier: 134579-RSG-20-058-01-PCSM
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer; Neoplasm Malignant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  Post-test of Visit 1, typically day 1

• Aim 2b: Palliative Care Utilization

  Up to 90 days

• 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

• Aim 3c: Edmonton Symptom Assessment Scale (ESAS)-Physical

  Follow-up at 14, 90, and 180 days

Other Outcomes (10)

• Exploratory: Brief COPE Inventory

  Follow-up at 14 days

• Exploratory: PROMIS Anger

  Follow-up at 90 days

• Exploratory: PROMIS Positive Affect

  Follow-up at 90 days

Study Arms (2)

Multimedia Psychoeducational Intervention + Enhanced Usual Care

EXPERIMENTAL

Intervention participants receive the Multimedia Psychoeducational Intervention in addition to Enhanced Usual Care

Behavioral: Multimedia Psychoeducational Intervention; Behavioral: Enhanced Usual Care

Enhanced Usual Care

OTHER

Control participants receive Enhanced Usual Care

Behavioral: Enhanced Usual Care

Interventions

Multimedia Psychoeducational Intervention BEHAVIORAL

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

Multimedia Psychoeducational Intervention + Enhanced Usual Care

Enhanced Usual Care BEHAVIORAL

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)

Enhanced Usual Care; Multimedia Psychoeducational Intervention + Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tulane University: lead
• American Cancer Society, Inc.: collaborator
• University Medical Center-New Orleans: collaborator

Study Sites (2)

University Medical Center

New Orleans, Louisiana, 70112, United States

Location

Tulane University

New Orleans, Louisiana, 70115, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Michael Hoerger, PhD, MSCR, MBA

  Tulane University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology, Psychiatry, and Oncology

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 2, 2021
• Study Start: March 31, 2021
• Primary Completion: April 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: By the study end date, available for at least 3 years.
• Access Criteria: Contact the Study PI

Locations

US (2)