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Recruiting
NCT06055296
Multisite Implementation of COMPRENDO
Conditions: Pediatric Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 450
Sponsor: University of California, San Diego
Location: Children's of Alabama/University of Alabama at Birmingham Birmingham Alabama
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.
Eligibility Criteria
Non-Stakeholder/Stakeholder Parent Eligibility criteria: A parent/legal guardian who has a Hispanic child aged 0 to 17y with a new diagnosis of cancer, has a child who is eligible for a therapeutic cancer clinical trial, will participate in an informed consent discussion for the therapeutic clinical trial, understands written and spoken English or Spanish, and has signed the consent form for the proposed COMPRENDO study. Participants will not be eligible if their child has second malignancy/relapse, was diagnosed at an outside institution, has potential transfer of care, was previously on a clinical trial
Stakeholder Clinician/Navigator/Administrator Clinicians, navigators and administrators who work at each site, are involved in treating pediatric patients and who are involved in the informed consent conference for clinical trials.
Source: ClinicalTrials.gov (NCT06055296). StuddyBuddy aggregates publicly available trial information.
