Multisite Implementation of COMPRENDO (COMPRENDO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Cancer
• Intervention / Treatment: Other: COMPRENDO Peer Navigation Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: M.Paula Aristizabal, MD, MAS; Phone Number: 858-966-5811; Email: paristizabal@rchsd.org

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Recruiting
      • Children's of Alabama/University of Alabama at Birmingham
      • Contact: Julie A Wolfson, MD, MSHS; Phone Number: 205-638-9285; Email: jwolfson@uabmc.edu
  • California
    • San Diego, California, United States, 92123
      • Recruiting
      • Rady Children's Hospital San Diego/University of California San Diego Moores Cancer Center
      • Contact: M.Paula Aristizabal, MD, MAS; Phone Number: 858-966-5811; Email: paristizabal@rchsd.org
    • San Francisco, California, United States, 94609
      • Recruiting
      • University of California San Francisco Benioff Children's Hospitals
      • Contact: Lena Winestone, MD, MHSP; Phone Number: 415-476-2188; Email: COMPRENDO@ucsf.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Dana Farber Cancer Institute/Boston Children's Hospital
      • Contact: Kira Bona, MD, MPH; Phone Number: 617-632-4688; Email: kira.bona@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Non-Stakeholder/Stakeholder Parent Eligibility criteria: A parent/legal guardian who has a Hispanic child aged 0 to 17y with a new diagnosis of cancer, has a child who is eligible for a therapeutic cancer clinical trial, will participate in an informed consent discussion for the therapeutic clinical trial, understands written and spoken English or Spanish, and has signed the consent form for the proposed COMPRENDO study. Participants will not be eligible if their child has second malignancy/relapse, was diagnosed at an outside institution, has potential transfer of care, was previously on a clinical trial

Stakeholder Clinician/Navigator/Administrator Clinicians, navigators and administrators who work at each site, are involved in treating pediatric patients and who are involved in the informed consent conference for clinical trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COMPRENDO 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.	Other: COMPRENDO Peer Navigation Intervention; 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.
No Intervention: Usual Care; Parents will participate in an informed consent conference with the oncologist to discuss treatment options for the child as per each institution's procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Informed Consent Comprehension	Informed Consent Comprehension will be assessed using the Quality of Informed Consent (QuIC), a valid 20-item instrument that assesses objective understanding of the basic elements of Informed Consent. The summary score potentially ranges from 0 to 100. The highest the summary score, the highest the comprehension.	12 weeks
Voluntariness	Voluntariness will be assessed using the Decision-making Control Instrument (DMCI), a 9-item, Likert-format scale, which is used in parents who make decisions about research, including cancer. The instrument score range from 9-54, the higher score equals to higher perception of voluntariness.	12 weeks
Decision-Making Self-Efficacy	Decision-Making Self Efficacy will be assessed with the 11-item Decision Self-Efficacy Scale (DSE), a 5-point scale which measures self-confidence in decision making (shared decision making, decision conflict, feeling informed and supported). Score range from 0 [not at all confident] to 100 [very confident]. A score of 0 means extremely low self efficacy and a score of 100 means extremely high self efficacy.	12 weeks
Decisional Regret	The 5-item Decisional Regret Scale will measure regret after health-care decisions. Score range is from 0 to 100. A score of 0 means no regret; a score of 100 means high regret.	12 weeks
Satisfaction with informed consent	Satisfaction with informed consent will be measured with a 24-item satisfaction questionnaire to evaluate parents' perceptions of overall satisfaction with the IC discussion (satisfaction with ICs explanation, quantity of information, utility of the IC, affective responses).The score ranges from 7-21. A score of 7 meaning least satisfied; a score of 21 most satisfied.	12 weeks
Trust in Research	Assesses individual's views on research studies.	12 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability (parents)	Acceptability of COMPRENDO will be assessed in parents the 9-item Patient Satisfaction with Navigator (PSN-I). The score ranges from 9-45. A higher score on the PSN-I indicates higher satisfaction with their interpersonal relationship with the patient navigator. Our acceptability goal is >80%	Year 1-Year 5
Acceptability (clinicians)	Acceptability of COMPRENDO will be assessed in clinicians with the 6-item Intervention Credibility Scale. The score ranges from 4-20. Higher scores indicate greater acceptability. Our acceptability goal is >80%	Year 1-Year 5
Feasibility	Feasibility will be assessed by 4-item Feasibility of Intervention measure. The score ranges from 4-20. Higher scores indicate greater feasibility. Our feasibility goal is >80%.	Year 1-Year 5
Fidelity	Fidelity will be assessed by measuring adherence to the fidelity navigator checklist. Our fidelity goal is >90%.	Year 1-Year 5

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: National Cancer Institute (NCI); Dana-Farber Cancer Institute; University of Alabama at Birmingham; University of California, San Francisco
• Investigators: Principal Investigator: M.Paula Aristizabal, MD, MAS, University of California, San Diego

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Patient Navigation; Cancer Disparities; Research Literacy; Minority Clinical Trial Accrual
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 808092; 1R01CA279945-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No