RECRUITING

Multisite Implementation of COMPRENDO

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-11
Study Completion:2028-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06055296

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * are a Hispanic parent/primary legal guardian;
  2. * has a child aged 0 to 17 y with a new diagnosis of cancer or cancer-like disease (histiocytic disorders or myelodysplastic syndromes);
  3. * has a child who is eligible for a therapeutic cancer clinical trial;
  4. * will participate in an informed consent discussion for the therapeutic clinical trial;
  5. * has an understanding of written and spoken English or Spanish;
  6. * has signed the consent form for the proposed COMPRENDO study.
  1. * second malignancy/relapse;
  2. * diagnosed at an outside institution;
  3. * potential transfer of care to another institution within the next 4 months;
  4. * previously on a clinical trial;
  5. * does not understand written and spoken English or Spanish;
  6. * not Hispanic.

Contacts and Locations

Study Contact

M.Paula Aristizabal, MD, MAS
CONTACT
858-966-5811
paristizabal@rchsd.org

Principal Investigator

M.Paula Aristizabal, MD, MAS
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

Children's of Alabama/University of Alabama at Birmingham
Birmingham, Alabama, 35243
United States
Rady Children's Hospital San Diego/University of California San Diego Moores Cancer Center
San Diego, California, 92123
United States
University of California San Francisco Benioff Children's Hospitals
San Francisco, California, 94609
United States
Dana Farber Cancer Institute/Boston Children's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • M.Paula Aristizabal, MD, MAS, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-11
Study Completion Date2028-06-30

Study Record Updates

Study Start Date2024-01-11
Study Completion Date2028-06-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Pediatric Cancer