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

Not Applicable

Recruiting

• Conditions: Educational Intervention; Minorities
• Interventions: Other: Educational Intervention

• Registration Number: NCT05701085
• Lead Sponsor: Case Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2022-11-29
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-01-27
• Study Start: 2023-04-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRE-ACT Adaptation	Educational Intervention	At the scheduled oncologic visit: consent obtained and all participants will complete the Demographics/Clinical Characteristics survey and Pre-Intervention Survey Within 3 months of consent: tailored educational intervention and patient navigation program will take place and the scored Pre-Intervention survey will be used to generate a list of barrier for each patient. 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. Within 4 weeks of the educational video: the participant will be contacted via phone to complete a Post-Intervention Survey that assesses knowledge, attitudes, and preparation related to participation in clinical trials Two years after intervention: chart review will be performed to assess if the patient participated in a clinical trial.

Primary Outcome Measures

Name	Time	Method
Change in knowledge regarding cancer clinical trials after the intervention	Up to 4 months	Change 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 intervention	Up to 4 months	A 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.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States