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Patient Navigator PRE-ACT Educational Intervention to Promote Decision Making Among Minorities

Prospective Cohort Study of a Patient Navigator PRE-ACT Educational Intervention to Promote Decision Making About Clinical Trials Among Racial and Ethnic Minorities

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05701085
Enrollment
240
Registered
2023-01-27
Start date
2023-04-24
Completion date
2026-12-30
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Educational Intervention, Minorities

Keywords

PRE-ACT

Brief summary

This study focuses on psychosocial barriers at the patient level with the goal of promoting high quality decision making around clinical trials participation. The proposed study adapts the PRE-ACT model to racial and ethnic minority patients who were underrepresented in the original PRE-ACT study and will be combined with a patient navigator model.

Detailed description

The primary objective of the proposed research is to employ a non-directive method to improve preparedness for consideration of clinical trials among racial minority patients by providing tailored information to address knowledge and attitudes towards clinical trials. This model has been previously studied in a primarily white, well-educated population. It is unknown how well this model adapts to meet the needs of diverse patient populations.

Interventions

OTHEREducational Intervention

The intervention will occur at a separate dedicated in-person visit with the patient navigator estimated to last 30-45 minutes. The Pre-Intervention Survey will be scored to generate a list of barriers identified for each patient. This list of barriers will be reviewed by the patient navigator prior to the intervention date. The patient will be asked to view educational videos on an iPad that correspond with each identified barrier. Afterwards, the patient navigator will lead a discussion based on the topics discussed.

Sponsors

Case Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Participants must have a diagnosis of either advanced (metastatic) cancer or early stage disease for which they are undergoing oncological work-up, treatment or surveillance * Participants must be at least 18 years of age * Participants have a non-white race or Hispanic ethnicity recorded in their patient demographics in the electronic medical record * Participant must have a life expectancy greater than three months based on the primary oncology team's clinical assessment. * Participants must be able to read and verbally communicate in English. * Participants must provide written informed consent.

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Change in knowledge regarding cancer clinical trials after the interventionUp to 4 monthsChange in knowledge regarding cancer clinical trials after the intervention will be assessed by change in Pre and Post Intervention Survey Knowledge Score (scored from Items 1-8) with a higher score correlating to a greater change in knowledge.
Change in attitudes regarding cancer clinical trials after the interventionUp to 4 monthsA change in attitude will be recorded using changes in Pre and Post Intervention Survey Attitude Scores (scored from Items 9-21) with a higher score correlating to a greater change in attitude.

Countries

United States

Contacts

CONTACTLauren Chiec, MD
lauren.chiec@uhhospitals.org216-286-6741
PRINCIPAL_INVESTIGATORLauren Chiec, MD

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026