Multisite Implementation of COMPRENDO

NCT06055296 | Recruiting DMC

• 2 other identifiers: 8080921R01CA279945-01
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Research Literacy; Cancer Disparities; Minority Clinical Trial Accrual; Patient Navigation

Outcome Measures

Primary Outcomes (1)

• Accrual

  Measured by a higher proportion of children enrolled in therapeutic trials whose parents are randomized to COMPRENDO vs. the proportion of children enrolled in therapeutic trials whose parents are randomized to usual care.

  12 weeks

Secondary Outcomes (6)

• Informed Consent Comprehension

  12 weeks

• Voluntariness

  12 weeks

• Decision-Making Self-Efficacy

  12 weeks

• Decisional Regret

  12 weeks

• Satisfaction with informed consent

  12 weeks

Other Outcomes (4)

• Acceptability (parents)

  Year 1-Year 5

• Acceptability (clinicians)

  Year 1-Year 5

• Feasibility

  Year 1-Year 5

Study Arms (2)

COMPRENDO Intervention

EXPERIMENTAL

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.

Other: COMPRENDO Peer Navigation Intervention

Usual Care

NO 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.

Interventions

COMPRENDO Peer Navigation Intervention OTHER

Parents randomized to the intervention, COMPRENDO, will receive culture, language, and health literacy-concordant pre-accrual, accrual, and post-accrual activities in person led by a peer navigator for up to 4 weeks. Visit 1 (V1) will provide anticipatory guidance and education on a) general concepts of pediatric cancer research (standard of care, clinical trials, randomization); b) informed consent/assent, research affiliations (e.g., Children's Oncology Group); c) clinical trial types (therapeutic, non-therapeutic); d) voluntariness; and e) "frequently asked questions", resources. Navigators will follow a script supported by culture, language and health-literacy concordant handouts and graphic materials, decision aids, and short video-clips. Navigators also provide support with decision-making and answer parents' questions. Three follow-up peer navigator visits (V2, V3, V4) over 4 weeks are tailored to the parents' needs.

COMPRENDO Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Clinicians and parents of children with cancer who have participated in IC discussion for a cancer therapeutic clinical trial.
• Clinicians and parents of children with cancer who have not participated in IC discussion for a cancer therapeutic clinical trial.

Sponsors & Collaborators

• University of California, San Diego: lead
• Dana-Farber Cancer Institute: collaborator
• University of California, San Francisco: collaborator
• University of Alabama at Birmingham: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Children's of Alabama/University of Alabama at Birmingham

Birmingham, Alabama, 35243, United States

RECRUITING

Rady Children's Hospital San Diego/University of California San Diego Moores Cancer Center

San Diego, California, 92123, United States

RECRUITING

University of California San Francisco Benioff Children's Hospitals

San Francisco, California, 94609, United States

RECRUITING

Dana Farber Cancer Institute/Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (4)

• Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

  PMID: 22310560 BACKGROUND

• Palinkas LA, Mendon SJ, Hamilton AB. Innovations in Mixed Methods Evaluations. Annu Rev Public Health. 2019 Apr 1;40:423-442. doi: 10.1146/annurev-publhealth-040218-044215. Epub 2019 Jan 11.

  PMID: 30633710 BACKGROUND

• Moullin JC, Dickson KS, Stadnick NA, Rabin B, Aarons GA. Systematic review of the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. Implement Sci. 2019 Jan 5;14(1):1. doi: 10.1186/s13012-018-0842-6.

  PMID: 30611302 BACKGROUND

• Freeman HP. Patient navigation: a community based strategy to reduce cancer disparities. J Urban Health. 2006 Mar;83(2):139-41. doi: 10.1007/s11524-006-9030-0. No abstract available.

  PMID: 16736361 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• M.Paula Aristizabal, MD, MAS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

M.Paula Aristizabal, MD, MAS

CONTACT

858-966-5811; paristizabal@rchsd.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Pediatrics, Division of Pediatric Hematology/Oncology

Model Details: We will use a Hybrid 1 design that combines a randomized effectiveness trial and a mixed methods observational implementation evaluation. Hybrid designs assess both clinical effectiveness and implementation, thus bridging the gap between two research areas.

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 26, 2023
• Study Start: January 11, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

US (4)