Educational intervention to help minorities make informed decisions about clinical trials
Prospective Cohort Study of a Patient Navigator PRE-ACT Educational Intervention to Promote Decision Making About Clinical Trials Among Racial and Ethnic Minorities
This study is testing a new way to help racial and ethnic minority patients feel more informed and confident about joining clinical trials.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05701085 on ClinicalTrials.gov |
What this trial studies
This study aims to address psychosocial barriers that prevent racial and ethnic minority patients from participating in clinical trials. By adapting the PRE-ACT model, the research will provide tailored information to improve knowledge and attitudes towards clinical trials among these underrepresented groups. The intervention will utilize a patient navigator model to enhance decision-making preparedness for clinical trial participation. The effectiveness of this approach is being evaluated in a population that was previously not well represented in similar studies.
Who should consider this trial
Good fit: Ideal candidates for this study are non-white or Hispanic patients aged 18 and older with a diagnosis of advanced or early-stage cancer.
Not a fit: Patients who are not racial or ethnic minorities or those who do not have a cancer diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could empower minority patients to make informed decisions about participating in clinical trials, potentially improving their treatment options.
How similar studies have performed: While the PRE-ACT model has shown success in primarily white populations, its adaptation for diverse groups is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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: \-
Where this trial is running
Cleveland, Ohio
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Lauren Chiec, MD — University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
- Study coordinator: Lauren Chiec, MD
- Email: lauren.chiec@uhhospitals.org
- Phone: 216-286-6741
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.