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Multisite Implementation of COMPRENDO
Sponsor: University of California, San Diego
Summary
COMPRENDO (ChildhOod Malignancy Peer Research NavigatiOn) is a multi-site randomized clinical trial (RCT) that uses a Hybrid Type 1 design, to test the effects of a clinical intervention on patient-level outcomes, while exploring multilevel implementation factors that can inform real-world setting implementation. This study will test the impact of COMPRENDO, a peer-navigation intervention, vs. usual care on accrual to childhood cancer therapeutic clinical trials and parental informed consent outcomes. COMPRENDO will be delivered by trained peer navigators in 4 visits. A mixed methods (surveys, individual interviews) implementation evaluation will examine implementation factors that can inform the use of peer navigation in clinical practice, integrating data from clinicians, navigators, administrators, and parents pre and post the RCT.
Official title: Multisite Implementation of COMPRENDO (ChildhOod Malignancy Peer REsearch NavigatiOn) to Improve Participation of Hispanic Children in Cancer Clinical Trials
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2024-01-11
Completion Date
2029-06-30
Last Updated
2026-02-20
Healthy Volunteers
Yes
Conditions
Interventions
COMPRENDO Peer Navigation Intervention
Parents randomized to the intervention, COMPRENDO, will receive culture, language, and health literacy-concordant pre-accrual, accrual, and post-accrual activities in person led by a peer navigator for up to 4 weeks. Visit 1 (V1) will provide anticipatory guidance and education on a) general concepts of pediatric cancer research (standard of care, clinical trials, randomization); b) informed consent/assent, research affiliations (e.g., Children's Oncology Group); c) clinical trial types (therapeutic, non-therapeutic); d) voluntariness; and e) "frequently asked questions", resources. Navigators will follow a script supported by culture, language and health-literacy concordant handouts and graphic materials, decision aids, and short video-clips. Navigators also provide support with decision-making and answer parents' questions. Three follow-up peer navigator visits (V2, V3, V4) over 4 weeks are tailored to the parents' needs.
Locations (4)
Children's of Alabama/University of Alabama at Birmingham
Birmingham, Alabama, United States
Rady Children's Hospital San Diego/University of California San Diego Moores Cancer Center
San Diego, California, United States
University of California San Francisco Benioff Children's Hospitals
San Francisco, California, United States
Dana Farber Cancer Institute/Boston Children's Hospital
Boston, Massachusetts, United States