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.
Conditions
Pediatric Cancer
Recruitment Status
Not yet recruiting
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 (informed consent, comprehension, voluntariness, decision-making self-efficacy, satisfaction with informed consent and decisional regret). Aim 3: Evaluate multisite implementation of COMPRENDO, focusing on acceptability, feasibility, and fidelity. We will use mixed methods with a minimum of 50 stakeholders: 22 clinicians, (17 oncologists, 3 psychologists, 2 social workers), 4 navigators, 4 administrators and 20 parents to identify implementation factors. Within each site, eligible participants will be randomized 1:1 to the intervention vs. usual care (informed consent discussion with the oncologist only), resulting in ≈200 participants randomized to each arm.
Eligibility Criteria
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 Criteria:
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 Exclusion Criteria:
Clinicians and parents of children with cancer who have not participated in IC discussion for a cancer therapeutic clinical trial.
Intervention
Intervention Type
Intervention Name
Other
COMPRENDO Peer Navigation Intervention
Phase
Not Applicable
Gender
All
Min Age
18 Years
Max Age
N/A
Download Date
September 29, 2023
Principal Investigator
M. Paula Aristizabal
Primary Contact Information
kira.bona@childrens.harvard.edu
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: