Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Diego, California and other locations
Dates
study started
completion around
Principal Investigator
by M.Paula Aristizabal, MD, MAS

Description

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.

Official Title

Multisite Implementation of COMPRENDO (ChildhOod Malignancy Peer REsearch NavigatiOn) to Improve Participation of Hispanic Children in Cancer Clinical Trials

Details

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.

Keywords

Pediatric Cancer, Research Literacy, Cancer Disparities, Minority Clinical Trial Accrual, Patient Navigation, COMPRENDO Peer Navigation Intervention

Eligibility

For people ages 18 years and up

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.

Locations

  • Rady Children's Hospital San Diego/University of California San Diego Moores Cancer Center
    San Diego California 92123 United States
  • University of California San Francisco Benioff Children's Hospitals
    San Francisco California 94609 United States
  • Children's of Alabama/University of Alabama at Birmingham
    Birmingham Alabama 35243 United States
  • Dana Farber Cancer Institute/Boston Children's Hospital
    Boston Massachusetts 02115 United States

Lead Scientist at UCSD

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT06055296
Study Type
Interventional
Participants
Expecting 450 study participants
Last Updated