RecruitingInterventional

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

NCT ID: NCT06055296Sponsor: University of California, San DiegoLast updated: 2026-06-03

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.

Detailed description

Aim 1: Test the effectiveness of COMPRENDO vs. usual care to increase clinical trial accrual in a multisite RCT. Aim 2: Determine the impact of COMPRENDO vs. usual care on parental outcomes (informed consent, comprehension, voluntariness, decision-making self-efficacy, satisfaction with informed consent and decisional regret). Aim 3: Evaluate multisite implementation of COMPRENDO, focusing on acceptability, feasibility, and fidelity. We will use mixed methods with a minimum of 50 stakeholders: 22 clinicians, (17 oncologists, 3 psychologists, 2 social workers), 4 navigators, 4 administrators and 20 parents to identify implementation factors. Within each site, eligible participants will be randomized 1:1 to the intervention vs. usual care (informed consent discussion with the oncologist only), resulting in ≈200 participants randomized to each arm.

Arms & 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.

Outcome measures

Primary

Accrual
Measured by a higher proportion of children enrolled in therapeutic trials whose parents are randomized to COMPRENDO vs. the proportion of children enrolled in therapeutic trials whose parents are randomized to usual care.
Time frame: 12 weeks

Secondary

Informed Consent Comprehension
Time frame: 12 weeks
Voluntariness
Time frame: 12 weeks
Decision-Making Self-Efficacy
Time frame: 12 weeks
Decisional Regret
Time frame: 12 weeks
Satisfaction with informed consent
Time frame: 12 weeks
Trust in Research
Time frame: 12 Weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: Yes

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.

Study locations (4)

Children's of Alabama/University of Alabama at Birmingham

Birmingham, Alabama, 35243

Recruiting

Julie A Wolfson, MD, MSHS · Contact

205-638-9285 jwolfson@uabmc.edu

Rady Children's Hospital San Diego/University of California San Diego Moores Cancer Center

San Diego, California, 92123

Recruiting

M.Paula Aristizabal, MD, MAS · Contact

858-966-5811 paristizabal@rchsd.org

University of California San Francisco Benioff Children's Hospitals

San Francisco, California, 94609

Recruiting

Lena Winestone, MD, MHSP · Contact

415-476-2188 COMPRENDO@ucsf.edu

Dana Farber Cancer Institute/Boston Children's Hospital

Boston, Massachusetts, 02115

Recruiting

Kira Bona, MD, MPH · Contact

617-632-4688 kira.bona@childrens.harvard.edu

References

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Palinkas LA, Mendon SJ, Hamilton AB. Innovations in Mixed Methods Evaluations. Annu Rev Public Health. 2019 Apr 1;40:423-442. doi: 10.1146/annurev-publhealth-040218-044215. Epub 2019 Jan 11.(PubMed)
Moullin JC, Dickson KS, Stadnick NA, Rabin B, Aarons GA. Systematic review of the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. Implement Sci. 2019 Jan 5;14(1):1. doi: 10.1186/s13012-018-0842-6.(PubMed)
Freeman HP. Patient navigation: a community based strategy to reduce cancer disparities. J Urban Health. 2006 Mar;83(2):139-41. doi: 10.1007/s11524-006-9030-0. No abstract available.(PubMed)