EMPOWER 3: Improving Palliative Care Health Literacy and Utilization
NCT ID: NCT04733469
Last Updated: 2024-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
172 participants
INTERVENTIONAL
2021-03-31
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Multimedia Psychoeducational Intervention + Enhanced Usual Care
Intervention participants receive the Multimedia Psychoeducational Intervention in addition to Enhanced Usual Care
Multimedia Psychoeducational Intervention
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
Enhanced Usual Care
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)
Enhanced Usual Care
Control participants receive Enhanced Usual Care
Enhanced Usual Care
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)
Interventions
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Multimedia Psychoeducational Intervention
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
Enhanced Usual Care
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)
Eligibility Criteria
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Inclusion Criteria
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
* Significant psychiatric or other co-morbid disease that would prohibit informed consent or participation in the study
* Unlikely to complete any follow-up surveys
18 Years
ALL
No
Sponsors
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American Cancer Society, Inc.
OTHER
University Medical Center-New Orleans
UNKNOWN
Tulane University
OTHER
Responsible Party
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Michael Hoerger, PhD, MSCR
Associate Professor of Psychology, Psychiatry, and Oncology
Principal Investigators
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Michael Hoerger, PhD, MSCR, MBA
Role: PRINCIPAL_INVESTIGATOR
Tulane University
Locations
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University Medical Center
New Orleans, Louisiana, United States
Tulane University
New Orleans, Louisiana, United States
Countries
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Central Contacts
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Facility Contacts
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Michael Hoerger, PhD, MSCR, MBA
Role: primary
Michael Hoerger, PhD, MSCR, MBA
Role: primary
Other Identifiers
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134579-RSG-20-058-01-PCSM
Identifier Type: -
Identifier Source: org_study_id
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