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 — OTHER
    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.

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 Adaptation
    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 Measure

Change in knowledge regarding cancer clinical trials after the intervention [ Time Frame: Up to 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterClevelandOhio44106
Lauren Chiec, MD
216-286-6741

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