Clinical trial NCT04733469: EMPOWER 3: Improving Palliative Care Health Literacy and Utilization
Official title: EMPOWER 3: Improving Palliative Care Health Literacy and Utilization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Neoplasm Malignant
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: University Medical Center-New Orleans
First posted: 2021-02-02
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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 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
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

Primary outcomes:
measure: Aim 1: Palliative Care Knowledge Scale (PaCKS)
timeFrame: Post-test of Visit 1, typically day 1
Secondary outcomes:
measure: Aim 2a: Palliative Care Attitudes Scale (PCAS-9)
timeFrame: Post-test of Visit 1, typically day 1
measure: Aim 2b: Palliative Care Utilization
timeFrame: Up to 90 days
measure: Aim 3a: Patient-Reported Outcome Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions
timeFrame: Follow-up at 14, 90, and 180 days
measure: Aim 3b: PROMIS Emotional Distress
timeFrame: Follow-up at 14, 90, and 180 days
measure: Aim 3c: Edmonton Symptom Assessment Scale (ESAS)-Physical
timeFrame: Follow-up at 14, 90, and 180 days
Other outcomes:
measure: Exploratory: Brief COPE Inventory
timeFrame: Follow-up at 14 days
measure: Exploratory: PROMIS Anger
timeFrame: Follow-up at 90 days
measure: Exploratory: PROMIS Positive Affect
timeFrame: Follow-up at 90 days
measure: Exploratory: PROMIS Stress
timeFrame: Follow-up at 90 days
measure: Exploratory: PROMIS General Self-Efficacy
timeFrame: Follow-up at 90 days
measure: Exploratory: Medication Adherence
timeFrame: Follow-up at 90 days
measure: Exploratory: PROMIS Emotional Support
timeFrame: Follow-up at 180 days
measure: Exploratory: PROMIS Cognitive Function
timeFrame: Follow-up at 180 days
measure: Exploratory: PROMIS Meaning and Purpose
timeFrame: Follow-up at 180 days
measure: Exploratory: Quality of Life in Neurologic Disorders (Neuro-QoL) Concern with Death and Dying
timeFrame: Follow-up at 180 days
Locations:
city: New Orleans
country: United States
facility: University Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
Study officials:
affiliation: Tulane University
name: Michael Hoerger, PhD, MSCR, MBA
role: PRINCIPAL_INVESTIGATOR
References: