Multisite Implementation of COMPRENDO

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.

Eligibility

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.

Conditions2

Locations4 sites

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