Recruiting

COMPRENDO

Sponsor:

UCLA

Code:

NCT06055296

Conditions

Pediatric Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

COMPRENDO Peer Navigation Intervention

Study Details

Brief 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.

Conditions

Pediatric Cancer

Study ID

NCT06055296

Start date

Jan 11, 2024

Status verified date

Feb, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: COMPRENDO Intervention

Parent participants randomized to the intervention group will receive the COMPRENDO intervention that includes 2-4 visits led by a peer navigator across a 4-week period. Navigator visits will last about 16 - 60 minutes depending upon the needs and desires of the parent. Navigator sessions will be conducted in the parents' preferred language (either English or Spanish). Peer navigators will:

  • Discuss general concepts related to informed consent and treatment options, including standard of care and clinical trials. The navigator will not discuss specific medications with parents.
  • Attend the informed consent discussion parents have with their child's oncologist.
  • Help parents come up with questions when the oncologist talks about cancer treatment options.
  • Go over the consent forms. Answer questions parents may have to the best of their ability.
  • Meet with parents over 4 weeks. During these meetings, the navigator will facilitate decision-making.

no intervention: Usual Care

Parents will participate in an informed consent conference with the oncologist to discuss treatment options for the child as per each institution's procedure.

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.

Primary outcome measure

  • Accrual [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

M.Paula Aristizabal, MD, MAS

858-966-5811paristizabal@rchsd.org

Locations

Children's of Alabama/University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35243

Contacts

Julie A Wolfson, MD, MSHS

205-638-9285jwolfson@uabmc.edu

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

Recruiting

San Diego, California, United States, 92123

Contacts

M.Paula Aristizabal, MD, MAS

858-966-5811paristizabal@rchsd.org

University of California San Francisco Benioff Children's Hospitals

Recruiting

San Francisco, California, United States, 94609

Contacts

Lena Winestone, MD, MHSP

415-476-2188COMPRENDO@ucsf.edu

Dana Farber Cancer Institute/Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Kira Bona, MD, MPH

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

More Information

Sponsor

University of California, San Diego

Last update posted

Jun 3, 2026

Last verified

Feb, 2026

Keywords

  • Research Literacy
  • Cancer Disparities
  • Minority Clinical Trial Accrual
  • Patient Navigation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-06-03.