EMPOWER 3: Improving Palliative Care Health Literacy and Utilization

Tulane University

Status: Enrolling

Conditions: Neoplasm Malignant; Cancer

Treatments: Behavioral: Multimedia Psychoeducational Intervention; Behavioral: Enhanced Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04733469

134579-RSG-20-058-01-PCSM

Details and patient eligibility

About

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.

Enrollment: 172 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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172 participants in 2 patient groups

Multimedia Psychoeducational Intervention + Enhanced Usual Care

Experimental group

Description:

Intervention participants receive the Multimedia Psychoeducational Intervention in addition to Enhanced Usual Care

Treatment:

Behavioral: Enhanced Usual Care

Behavioral: Multimedia Psychoeducational Intervention

Enhanced Usual Care

Other group

Description:

Control participants receive Enhanced Usual Care

Treatment:

Behavioral: Enhanced Usual Care