RecruitingNot ApplicableNCT06055296

Multisite Implementation of COMPRENDO

Multisite Implementation of COMPRENDO (ChildhOod Malignancy Peer REsearch NavigatiOn) to Improve Participation of Hispanic Children in Cancer Clinical Trials

Sponsor

University of California, San Diego

Enrollment

450 participants

Start Date

Jan 11, 2024

Study Type

INTERVENTIONAL

Conditions

Pediatric Cancer

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

Min Age: 18 Years

Inclusion Criteria2

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERCOMPRENDO 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.