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 Criteria7

are a Hispanic parent/primary legal guardian;
has a child aged 0 to 17 y with a new diagnosis of cancer or cancer-like disease (histiocytic disorders or myelodysplastic syndromes);
has a child who is eligible for a therapeutic cancer clinical trial;
will participate in an informed consent discussion for the therapeutic clinical trial;
has an understanding of written and spoken English or Spanish;
has signed the consent form for the proposed COMPRENDO study.
Clinicians and parents of children with cancer who have participated in IC discussion for a cancer therapeutic clinical trial.

Exclusion Criteria7

second malignancy/relapse;
diagnosed at an outside institution;
potential transfer of care to another institution within the next 4 months;
previously on a clinical trial;
does not understand written and spoken English or Spanish;
not Hispanic.
Clinicians and parents of children with cancer who have not participated in IC discussion for a cancer therapeutic clinical trial.

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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.