Patient Navigator PRE-ACT Educational Intervention to Promote Decision Making Among Minorities
Part of paid clinical trials in Cleveland, Ohio.
- Sponsor
- Case Comprehensive Cancer Center
- Study ID
- NCT05701085
- Status
- Recruiting
Conditions
- Educational Intervention
- Minorities
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Educational Intervention — OTHERThe 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.
Study Details
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.
Key Dates
- Start date
- Apr 24, 2023
- Status verified
- Apr 2026
- Primary completion
- Oct 30, 2026
- Completion
- Dec 30, 2026
Study Design
- Enrollment
- 240 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: PRE-ACT AdaptationAt 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 Measure
Change in knowledge regarding cancer clinical trials after the intervention [ Time Frame: Up to 4 months ]
Central Contacts
- Lauren Chiec, MD216-286-6741
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 |