EMPOWER 3: Improving Palliative Care Health Literacy and Utilization

Cancer Clinical Trial

— EMPOWER 3  

Official title:

EMPOWER 3: Improving Palliative Care Health Literacy and Utilization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04733469
• Other study ID #: 134579-RSG-20-058-01-PCSM
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2021
• Est. completion date: August 2025

Study information

• Verified date: June 2024
• Source: Tulane University
• Contact: Michael Hoerger, PhD, MSCR, MBA
• Phone: 504-314-7545
• Email: mhoerger[@]tulane.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: August 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß2-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

Related Conditions & MeSH terms

• Cancer
• Neoplasm Malignant
• Neoplasms

Intervention

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
• 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)

Locations

Country	Name	City	State
United States	Tulane University	New Orleans	Louisiana
United States	University Medical Center	New Orleans	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Tulane University	American Cancer Society, Inc., University Medical Center-New Orleans

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	Aim 2b: Palliative Care Utilization	Utilization of palliative care (presence/absence)	Up to 90 days
Secondary	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
Secondary	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
Secondary	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