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NCT Number: NCT04733469

EMPOWER 3: Improving Palliative Care Health Literacy and Utilization

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Neoplasm Malignant Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tulane University, New Orleans, Louisiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

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

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Aim 2b: Palliative Care Utilization

    Time frame: Up to 90 days

    Utilization of palliative care (presence/absence)

  3. 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

  4. 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

  5. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Collaborators

  • American Cancer Society, Inc.
  • University Medical Center New Orleans

Registry information

Acronym: EMPOWER 3

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2021
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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