[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520340":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":33,"responsibleParty":94,"collaborators":97,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":115,"sex":116,"minAge":117,"maxAge":18,"enrollmentInfo":118,"targetDuration":18,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":36,"whyStopped":18,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"University of California, San Diego","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"COMPRENDO Intervention","EXPERIMENTAL","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:\n\n* 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.\n* Attend the informed consent discussion parents have with their child's oncologist.\n* Help parents come up with questions when the oncologist talks about cancer treatment options.\n* Go over the consent forms. Answer questions parents may have to the best of their ability.\n* Meet with parents over 4 weeks. During these meetings, the navigator will facilitate decision-making.",[13],"Other: COMPRENDO Peer Navigation Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","NO_INTERVENTION","Parents will participate in an informed consent conference with the oncologist to discuss treatment options for the child as per each institution's procedure.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"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\u002Fassent, 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.",[9],[25],{"name":26,"affiliation":5,"role":27},"M.Paula Aristizabal, MD, MAS","PRINCIPAL_INVESTIGATOR",[29],{"name":26,"role":30,"phone":31,"phoneExt":18,"email":32},"CONTACT","858-966-5811","paristizabal@rchsd.org",[34,53,65,79],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Children's of Alabama\u002FUniversity of Alabama at Birmingham","RECRUITING","Birmingham","Alabama","35243","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-86.80249,33.52066,{"lat":46,"lon":45},[49],{"name":50,"role":30,"phone":51,"phoneExt":18,"email":52},"Julie A Wolfson, MD, MSHS","205-638-9285","jwolfson@uabmc.edu",{"facility":54,"status":36,"city":55,"state":56,"zip":57,"country":40,"countryCode":41,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Rady Children's Hospital San Diego\u002FUniversity of California San Diego Moores Cancer Center","San Diego","California","92123",{"type":43,"coordinates":59},[60,61],-117.16472,32.71571,{"lat":61,"lon":60},[64],{"name":26,"role":30,"phone":31,"phoneExt":18,"email":32},{"facility":66,"status":36,"city":67,"state":56,"zip":68,"country":40,"countryCode":41,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"University of California San Francisco Benioff Children's Hospitals","San Francisco","94609",{"type":43,"coordinates":70},[71,72],-122.41942,37.77493,{"lat":72,"lon":71},[75],{"name":76,"role":30,"phone":77,"phoneExt":18,"email":78},"Lena Winestone, MD, MHSP","415-476-2188","COMPRENDO@ucsf.edu",{"facility":80,"status":36,"city":81,"state":82,"zip":83,"country":40,"countryCode":41,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Dana Farber Cancer Institute\u002FBoston Children's Hospital","Boston","Massachusetts","02115",{"type":43,"coordinates":85},[86,87],-71.05977,42.35843,{"lat":87,"lon":86},[90],{"name":91,"role":30,"phone":92,"phoneExt":18,"email":93},"Kira Bona, MD, MPH","617-632-4688","kira.bona@childrens.harvard.edu",{"type":27,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"M. Paula Aristizabal","Associate Professor of Clinical Pediatrics, Division of Pediatric Hematology\u002FOncology",[98,100,102,104],{"name":99,"class":6},"Dana-Farber Cancer Institute",{"name":101,"class":6},"University of California, San Francisco",{"name":103,"class":6},"University of Alabama at Birmingham",{"name":105,"class":106},"National Cancer Institute (NCI)","NIH","100520340","multisite-implementation-of-comprendo-100520340",false,"NCT06055296","Multisite Implementation of COMPRENDO","Multisite Implementation of COMPRENDO (ChildhOod Malignancy Peer REsearch NavigatiOn) to Improve Participation of Hispanic Children in Cancer Clinical Trials","COMPRENDO","Non-Stakeholder\u002FStakeholder Parent Eligibility criteria: A parent\u002Flegal 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\u002Frelapse, was diagnosed at an outside institution, has potential transfer of care, was previously on a clinical trial\n\nStakeholder Clinician\u002FNavigator\u002FAdministrator 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.",true,"ALL","18 Years",{"count":119,"type":120},450,"ESTIMATED","INTERVENTIONAL",[123],"NA","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.",[126],"Pediatric Cancer",[128,129,130,131],"Research Literacy","Cancer Disparities","Minority Clinical Trial Accrual","Patient Navigation","2026-06-01",{"date":134,"type":135},"2026-06-03","ACTUAL",{"date":137,"type":135},"2024-01-11",{"date":139,"type":120},"2028-06-30",{"name":5,"class":6},4]