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Multisite Implementation of COMPRENDO

RECRUITINGN/ASponsored by University of California, San Diego
Actively Recruiting
PhaseN/A
SponsorUniversity of California, San Diego
Started2024-01-11
Est. completion2027-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites

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

Age: 18 Years+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.

Conditions2

CancerPediatric Cancer

Locations4 sites

Alabama

1 site
Children's of Alabama/University of Alabama at Birmingham
Birmingham, Alabama, 35243
Julie A Wolfson, MD, MSHS205-638-9285jwolfson@uabmc.edu

California

2 sites
Rady Children's Hospital San Diego/University of California San Diego Moores Cancer Center
M.Paula Aristizabal, MD, MAS858-966-5811paristizabal@rchsd.org
University of California San Francisco Benioff Children's Hospitals
Lena Winestone, MD, MHSP415-476-2188COMPRENDO@ucsf.edu

Massachusetts

1 site
Dana Farber Cancer Institute/Boston Children's Hospital
Kira Bona, MD, MPH617-632-4688kira.bona@childrens.harvard.edu

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