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Behavioural Intervention

Peer Navigation for Pediatric Cancer (COMPRENDO Trial)

N/A

Recruiting

Led By M.Paula Aristizabal, MD, MAS

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- has a child aged 0 to 17 y with a new diagnosis of cancer or cancer-like disease (histiocytic disorders or myelodysplastic syndromes);

Be older than 18 years old

Must not have

- does not understand written and spoken English or Spanish;

- second malignancy/relapse;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year 1-year 5

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the impact of a peer-navigation intervention vs. usual care on accrual to childhood cancer clinical trials and parental informed consent. It will also explore how to use this intervention in the real world.

Who is the study for?

This trial is for Hispanic parents or guardians with children aged 0-17 who have a new diagnosis of cancer or similar disease and are eligible for a therapeutic clinical trial. Participants must understand English or Spanish, agree to discuss informed consent, and not be planning to transfer care soon.

What is being tested?

COMPRENDO tests a peer-navigation intervention against usual care in pediatric cancer cases. It aims to improve the number of families participating in trials and enhance informed consent outcomes through four visits by trained navigators.

What are the potential side effects?

Since COMPRENDO involves non-medical peer support rather than drugs, it doesn't have typical side effects like medications do. However, there may be emotional or psychological impacts from participation that will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child, aged 0-17, was recently diagnosed with cancer or a similar disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I understand both written and spoken English or Spanish.

Select...

I have had cancer more than once.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 1-year 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year 1-year 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and year 1-year 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Accrual

Secondary study objectives

Decision-Making Self-Efficacy

Decisional Regret

Informed Consent Comprehension

+2 more

Other study objectives

Acceptability (clinicians)

Acceptability (parents)

Feasibility

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: COMPRENDO InterventionExperimental Treatment1 Intervention

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: * 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. * Attend the informed consent discussion parents have with their child's oncologist. * Help parents come up with questions when the oncologist talks about cancer treatment options. * Go over the consent forms. Answer questions parents may have to the best of their ability. * Meet with parents over 4 weeks. During these meetings, the navigator will facilitate decision-making.

Group II: Usual CareActive Control1 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.

0 / 3Eligibility criteria met