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Behavioral Intervention

PRISM Program for Chronic Illness Communication

Phase 2

Recruiting

Led By Crystal E Brown, MD, MA

Research Sponsored by University of Washington

Eligibility Criteria Checklist

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

Must have

Seriously ill adults with median life expectancy of two years or less (e.g. metastatic cancer or inoperable lung cancer, chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) <35% predicted or oxygen dependence, restrictive lung disease with total lung capacity (TLC) <50% predicted, New York Heart Association (NYHA) class III or IV heart failure, or Child's class C cirrhosis or Model for End Stage Liver Disease(MELD) >17)

At least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial tests if a program can help minority patients with serious illnesses communicate better with doctors and become more resilient.

Who is the study for?

This trial is for English-speaking adults over 18 with serious illnesses like advanced cancer, severe lung disease, heart failure, or liver disease. They should have a life expectancy of about two years or less and be hospitalized at specific centers. It's not for those with cognitive impairments that prevent them from completing surveys or participating in sessions.Check my eligibility

What is being tested?

The PRISM Race and Communication Pilot RCT is testing the 'Promoting Resilience in Stress Management' (PRISM) program to see if it can help improve resilience and patient-clinician communication among racial minority patients facing serious illness.See study design

What are the potential side effects?

Since PRISM involves non-medical interventions aimed at stress management and communication improvement, traditional physical side effects are not expected as part of this study.

Eligibility Criteria

Inclusion Criteria

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

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I have a serious illness with a life expectancy of 2 years or less.

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I am 18 years old or older.

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I can think clearly enough to fill out surveys and join sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

10-item Connor-Davidson Resilience Scale (CD-RISC)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PRISMExperimental Treatment1 Intervention

Patients in this arm will be recipients of the PRISM intervention

Group II: Usual CareActive Control1 Intervention

Patients in this arm will not receive the PRISM intervention, but will continue to receive usual care the discretion of their treating clinicians.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,847,706 Total Patients Enrolled

National Institute on Minority Health and Health Disparities (NIMHD)NIH

383 Previous Clinical Trials

1,216,299 Total Patients Enrolled

Crystal E Brown, MD, MAPrincipal InvestigatorUniversity of Washington

Media Library

Promoting Resilience in Stress Management (PRISM) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04915079 — Phase 2

Racial Discrimination Research Study Groups: PRISM, Usual Care

Racial Discrimination Clinical Trial 2023: Promoting Resilience in Stress Management (PRISM) Highlights & Side Effects. Trial Name: NCT04915079 — Phase 2

Promoting Resilience in Stress Management (PRISM) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04915079 — Phase 2

Frequently Asked Questions

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

Has the PRISM protocol been granted authorization by the FDA?

"With a score of 2, our team at Power assessed PRISM as moderately safe due to limited efficacy data in Phase 2 clinical trials."

Answered by AI

What is the current sample size of individuals involved in this research trial?

"Indeed, according to clinicaltrials.gov the trial is enrolling participants. This study was initially opened for participation on May 1st 2023 and had its most recent update on May 26th 2023. The investigators are looking for 60 patients from a single medical facility."

Answered by AI

Are there vacancies available to enrollees of this experiment?

"Affirmative. The clinicaltrials.gov site states that this research endeavour, which began on the 1st of May 2023, is recruiting subjects for participation. Specifically, 60 individuals are needed from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRISM Race and Communication Pilot RCT

Crystal Brown 2023. "PRISM Race and Communication Pilot RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04915079.