Status:
RECRUITING
Multisite Implementation of COMPRENDO
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Dana-Farber Cancer Institute
University of California, San Francisco
Conditions:
Pediatric Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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-le...
Detailed Description
Aim 1: Test the effectiveness of COMPRENDO vs. usual care to increase clinical trial accrual in a multisite RCT. Aim 2: Determine the impact of COMPRENDO vs. usual care on parental outcomes (inform...
Eligibility Criteria
Inclusion
- Participants (n≈400) will be parents of Hispanic children (0-17 years) with newly diagnosed cancer or cancer-like disease (histiocytic disorders or myelodysplastic syndromes) and eligible for a therapeutic clinical trial who meet the following inclusion 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.
- Parent
Exclusion
- 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.
- Stakeholder Inclusion Criteria:
- Clinicians and parents of children with cancer who have participated in IC discussion for a cancer therapeutic clinical trial.
- Stakeholder
Key Trial Info
Start Date :
January 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06055296
Start Date
January 11 2024
End Date
June 30 2028
Last Update
May 28 2024
Active Locations (4)
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1
Children's of Alabama/University of Alabama at Birmingham
Birmingham, Alabama, United States, 35243
2
Rady Children's Hospital San Diego/University of California San Diego Moores Cancer Center
San Diego, California, United States, 92123
3
University of California San Francisco Benioff Children's Hospitals
San Francisco, California, United States, 94609
4
Dana Farber Cancer Institute/Boston Children's Hospital
Boston, Massachusetts, United States, 02115