EMPOWER 3: Improving Palliative Care Health Literacy and Utilization

Study Overview
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Brief Summary
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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.

Official Title
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EMPOWER 3: Improving Palliative Care Health Literacy and Utilization

Conditions
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Cancer, Neoplasm Malignant

Intervention / Treatment
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* Behavioral: Multimedia Psychoeducational Intervention
* Behavioral: Enhanced Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult, age 18 or older New diagnosis, recurrence, or progression of cancer in the past 90 days 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimedia Psychoeducational Intervention + Enhanced Usual Care<br>Intervention participants receive the Multimedia Psychoeducational Intervention in addition to Enhanced Usual Care | Behavioral: Multimedia Psychoeducational Intervention<br>* 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<br>Behavioral: Enhanced Usual Care<br>* 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)<br>|
| Other: Enhanced Usual Care<br>Control participants receive Enhanced Usual Care | Behavioral: Enhanced Usual Care<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Aim 2b: Palliative Care Utilization | 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 | 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 | 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 | 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 |