EMPOWER 3: Improving Palliative Care Health Literacy and Utilization
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Tulane University
- Enrollment
- 172
- Locations
- 2
- Primary Endpoint
- Aim 1: Palliative Care Knowledge Scale (PaCKS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Multimedia Psychoeducational Intervention + Enhanced Usual Care
Intervention participants receive the Multimedia Psychoeducational Intervention in addition to Enhanced Usual Care
Intervention: Multimedia Psychoeducational Intervention (Behavioral)
Multimedia Psychoeducational Intervention + Enhanced Usual Care
Intervention participants receive the Multimedia Psychoeducational Intervention in addition to Enhanced Usual Care
Intervention: Enhanced Usual Care (Behavioral)
Enhanced Usual Care
Control participants receive Enhanced Usual Care
Intervention: Enhanced Usual Care (Behavioral)
Outcomes
Primary Outcomes
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
- Aim 2b: Palliative Care Utilization(Up to 90 days)
- Aim 3c: Edmonton Symptom Assessment Scale (ESAS)-Physical(Follow-up at 14, 90, and 180 days)
- Aim 2a: Palliative Care Attitudes Scale (PCAS-9)(Post-test of Visit 1, typically day 1)
- 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)
Investigators
Michael Hoerger, PhD, MSCR
Associate Professor of Psychology, Psychiatry, and Oncology
Tulane University