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Educational Intervention for Disparities in Clinical Trial Access
N/A
Recruiting
Led By Lauren Chiec, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up tp 28 months
Awards & highlights
No Placebo-Only Group
Summary
This trial seeks to make clinical trials more accessible to racial and ethnic minorities, using a patient navigator model to remove psychosocial barriers.
Who is the study for?
This trial is for non-white or Hispanic adults with advanced cancer or early stage disease under treatment or surveillance. They must be over 18, able to read and speak English, have a life expectancy over three months, and give written consent.
What is being tested?
The study tests an educational program adapted from the PRE-ACT model combined with patient navigation to help minority patients make informed decisions about participating in clinical trials.
What are the potential side effects?
Since this is an educational intervention rather than a medical treatment, traditional physical side effects are not expected. However, participants may experience psychological impacts from decision-making discussions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up tp 28 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up tp 28 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in attitudes regarding cancer clinical trials after the intervention
Change in knowledge regarding cancer clinical trials after the intervention
Other study objectives
Rate of racial/ethnic minority participation in cancer clinical trials before and after the intervention (exploratory outcome)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PRE-ACT AdaptationExperimental Treatment1 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.
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
467 Previous Clinical Trials
32,415 Total Patients Enrolled
Lauren Chiec, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Debora Bruno, MS, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have advanced cancer or early stage cancer and am under treatment or surveillance.I am 18 years old or older.I can read and speak English fluently.
Research Study Groups:
This trial has the following groups:- Group 1: PRE-ACT Adaptation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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