Peer navigation support for Hispanic parents of children with cancer
Multisite Implementation of COMPRENDO (ChildhOod Malignancy Peer REsearch NavigatiOn) to Improve Participation of Hispanic Children in Cancer Clinical Trials
NA · University of California, San Diego · NCT06055296
This study tests whether having trained peer supporters can help Hispanic parents of children with cancer get involved in clinical trials better than standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego (other) |
| Locations | 4 sites (Birmingham, Alabama and 3 other locations) |
| Trial ID | NCT06055296 on ClinicalTrials.gov |
What this trial studies
COMPRENDO is a multi-site randomized clinical trial designed to evaluate the effectiveness of a peer-navigation intervention compared to usual care for increasing participation in childhood cancer clinical trials. The intervention involves trained peer navigators who will assist parents through four visits, focusing on informed consent and decision-making processes. The study will also assess implementation factors through mixed methods, including surveys and interviews with various stakeholders, to enhance the integration of peer navigation in clinical practice. Approximately 400 participants will be involved, with a focus on Hispanic families facing newly diagnosed pediatric cancers.
Who should consider this trial
Good fit: Ideal candidates are Hispanic parents or legal guardians of children aged 0-17 with newly diagnosed cancer or cancer-like diseases who are eligible for a therapeutic clinical trial.
Not a fit: Patients who have a second malignancy, are diagnosed at an outside institution, or do not understand written and spoken English or Spanish may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve clinical trial enrollment and parental understanding of informed consent in pediatric cancer care.
How similar studies have performed: Other studies have shown success with peer navigation interventions in improving clinical trial accrual and informed consent processes, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Birmingham, Alabama and 3 other locations
- Children's of Alabama/University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
- Rady Children's Hospital San Diego/University of California San Diego Moores Cancer Center — San Diego, California, United States (RECRUITING)
- University of California San Francisco Benioff Children's Hospitals — San Francisco, California, United States (RECRUITING)
- Dana Farber Cancer Institute/Boston Children's Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: M.Paula Aristizabal, MD, MAS — University of California, San Diego
- Study coordinator: M.Paula Aristizabal, MD, MAS
- Email: paristizabal@rchsd.org
- Phone: 858-966-5811
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pediatric Cancer, Research Literacy, Cancer Disparities, Minority Clinical Trial Accrual, Patient Navigation