Multisite Implementation of COMPRENDO

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.

Conditions

Pediatric Cancer

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Study Overview

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Study Details

Study overview

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.

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

Multisite Implementation of COMPRENDO

Condition
Pediatric Cancer
Intervention / Treatment

-

Contacts and Locations

Birmingham

Children's of Alabama/University of Alabama at Birmingham, Birmingham, Alabama, United States, 35243

San Diego

Rady Children's Hospital San Diego/University of California San Diego Moores Cancer Center, San Diego, California, United States, 92123

San Francisco

University of California San Francisco Benioff Children's Hospitals, San Francisco, California, United States, 94609

Boston

Dana Farber Cancer Institute/Boston Children's Hospital, Boston, Massachusetts, United States, 02115

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of California, San Diego,

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

Study Record Dates

2028-06-30