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Educational Intervention for Cancer Palliative Care (EMPOWER 3 Trial)

N/A

Recruiting

Led By Michael Hoerger, PhD, MSCR

Research Sponsored by Tulane University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Advanced heart, lung, renal (kidney), or liver disease

Adult, age 18 or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up follow-up at 14, 90, and 180 days

Awards & highlights

EMPOWER 3 Trial Summary

This trial will test whether an educational intervention can help patients with cancer understand and use palliative care, and feel better emotionally and physically.

Who is the study for?

This trial is for adults in southeast Louisiana with serious cancer diagnoses, including various advanced stages of lung, hematologic malignancies, melanoma, leukemia, lymphoma, multiple myeloma, breast and genitourinary cancers. They must have been diagnosed or shown progression in the last 90 days and experience severe symptoms like pain or depression.Check my eligibility

What is being tested?

The study tests an educational intervention to improve understanding and use of palliative care among cancer patients. One group receives standard care plus brochures; the other gets this plus a special video and materials on palliative care. Family members can also participate in the intervention group.See study design

What are the potential side effects?

Since this trial focuses on education rather than medication or medical procedures, there are no direct side effects from interventions being studied. However, participants' emotional responses to content could vary.

EMPOWER 3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have severe heart, lung, kidney, or liver disease.

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I am 18 years old or older.

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My breast cancer is at stage IV.

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My melanoma is at stage IV.

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I have a blood cancer.

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I experience two or more severe symptoms like pain or tiredness.

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My GI cancer is at an advanced stage and cannot be surgically removed.

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My GU cancer is in stage IV.

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I have advanced lymphoma or multiple myeloma with specific blood and genetic markers.

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My lung cancer is at an advanced stage.

EMPOWER 3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ follow-up at 14, 90, and 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~follow-up at 14, 90, and 180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and follow-up at 14, 90, and 180 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Aim 1: Palliative Care Knowledge Scale (PaCKS)

Secondary outcome measures

Aim 2a: Palliative Care Attitudes Scale (PCAS-9)

Aim 2b: Palliative Care Utilization

Aim 3a: Patient-Reported Outcome Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions

+2 more

Other outcome measures

Exploratory: Brief COPE Inventory

Exploratory: Medication Adherence

Exploratory: PROMIS Anger

+7 more

Side effects data

From 2015 Phase 3 trial • 203 Patients • NCT01325714

13%

Deceased - Unrelated to Study

100%

80%

60%

40%

20%

Study treatment Arm

Arm 2: Enhanced Usual Care

Arm 1: PAVeD Intervention

EMPOWER 3 Trial Design

2Treatment groups

Experimental Treatment

Group I: Multimedia Psychoeducational Intervention + Enhanced Usual CareExperimental Treatment2 Interventions

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

Group II: Enhanced Usual CareExperimental Treatment1 Intervention

Control participants receive Enhanced Usual Care

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enhanced Usual Care

2019

Completed Phase 3

~8530

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tulane UniversityLead Sponsor

115 Previous Clinical Trials

226,330 Total Patients Enrolled

American Cancer Society, Inc.OTHER

224 Previous Clinical Trials

110,283 Total Patients Enrolled

University Medical Center-New OrleansUNKNOWN

2 Previous Clinical Trials

56 Total Patients Enrolled

Media Library

Multimedia Psychoeducational Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04733469 — N/A

Cancer Research Study Groups: Multimedia Psychoeducational Intervention + Enhanced Usual Care, Enhanced Usual Care

Cancer Clinical Trial 2023: Multimedia Psychoeducational Intervention Highlights & Side Effects. Trial Name: NCT04733469 — N/A

Multimedia Psychoeducational Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04733469 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open for this clinical research endeavor?

"Clinicaltrials.gov records indicate that this medical investigation is currently accepting participants and was initially posted on March 31st 2021, with the latest edits made April 25th 2022."

Answered by AI

How many participants have been included in the current research?

"Affirmative. According to information on clinicaltrials.gov, this study is currently looking for volunteers; it was initially posted on March 31st 2021 and its most recent update occurred April 25th 2022. The trial seeks 172 participants at two separate sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

EMPOWER 3: Improving Palliative Care Health Literacy and Utilization

Michael Hoerger, PhD, MSCR 2021. "EMPOWER 3: Improving Palliative Care Health Literacy and Utilization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04733469.