Navigating cancer clinical trials to boost participation and diversity
Guiding Participation Toward Understanding, Inclusion, Diversity, and Equity for Cancer Clinical Trials (GUIDE) Pilot Trial
This study is testing a new support program to help more diverse patients overcome challenges and join cancer clinical trials.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fred Hutchinson Cancer Center Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06484595 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a navigation intervention aimed at increasing participation and diversity in cancer clinical trials. The program, called GUIDE, employs trained navigators to assist potential participants in overcoming health-related social needs and financial barriers that hinder their involvement in clinical trials. Patients are randomized into two groups: one receiving navigation support and the other receiving standard supportive care. The goal is to enhance understanding and accessibility of clinical trials for underrepresented populations in cancer research.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been identified as potentially eligible for cancer clinical trials and have at least one health-related social need.
Not a fit: Patients who do not have any health-related social needs or who are under 18 years of age may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly increase the diversity and participation rates in cancer clinical trials, leading to more equitable treatment options.
How similar studies have performed: Other studies have shown success with similar navigation interventions in improving clinical trial participation, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥ 18 years of age * Identified as potentially eligible for an open clinical trial by clinical trial pre-screening (operating in breast, gastrointestinal \[GI\], and genitourinary \[GU\] clinics) * Have ≥ 1 health related social need, defined by * Food insecurity, housing instability, transportation challenges, or financial instability documented in the Supportive Cancer Care Questionnaire in Epic Electronic Medical Record (EPIC), OR * Concerns about insurance, cost of trial, additional trial visits, travel, transportation, childcare, OR unable to take time off work documented by clinical trial pre-screening (CTPS), OR * Medicaid insurance documented in EPIC * Able to speak English Exclusion Criteria: * Unable to speak English * Children, adolescents, and teens under the age of 18 years * Patients participating on clinical trials providing financial navigation, such as clinicaltrials.gov identifier (CT ID): NCT04960787 * Patients refusing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization
Where this trial is running
Seattle, Washington
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Jason Mendoza, MD, MPH — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Jean A. McDougall, PhD, MPH
- Email: jamcdoug@fredhutch.org
- Phone: 206.667.6452
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.