RECRUITING

EMPOWER 3: Improving Palliative Care Health Literacy and Utilization

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

EMPOWER 3: Improving Palliative Care Health Literacy and Utilization

Quick Facts

Study Start:2021-03-31
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04733469

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult, age 18 or older
  2. 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:
  3. * Advanced cancer, such as:
  4. * Lung Cancer: Stage IIIB or IV non-small cell, or extensive stage small cell
  5. * Breast Cancer: Stage IV
  6. * Gastrointestinal (GI) Cancers: Unresectable stage III or stage IV
  7. * Genitourinary (GU) Cancers: Stage IV
  8. * Melanoma: Stage IV
  9. * Hematologic Malignancies
  10. * 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
  11. * 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
  12. * Advanced heart, lung, renal (kidney), or liver disease
  13. * Two or more severe symptoms (≥7 on 0-10 scale): pain, tiredness, drowsiness, nausea, bad appetite, shortness of breath, depression, or anxiety
  14. 3. Patient can understand spoken or written English
  15. 4. Patient receives care in southeast Louisiana
  1. * Known history of receiving specialty palliative care or hospice
  2. * Significant psychiatric or other co-morbid disease that would prohibit informed consent or participation in the study
  3. * Unlikely to complete any follow-up surveys

Contacts and Locations

Study Contact

Michael Hoerger, PhD, MSCR, MBA
CONTACT
504-314-7545
mhoerger@tulane.edu

Principal Investigator

Michael Hoerger, PhD, MSCR, MBA
PRINCIPAL_INVESTIGATOR
Tulane University

Study Locations (Sites)

University Medical Center
New Orleans, Louisiana, 70112
United States
Tulane University
New Orleans, Louisiana, 70115
United States

Collaborators and Investigators

Sponsor: Tulane University

  • Michael Hoerger, PhD, MSCR, MBA, PRINCIPAL_INVESTIGATOR, Tulane University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-31
Study Completion Date2025-08

Study Record Updates

Study Start Date2021-03-31
Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

  • Cancer
  • Neoplasm Malignant