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NCT Number: NCT06055296

Multisite Implementation of COMPRENDO

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.

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Key information

Conditions

Pediatric Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's of Alabama/University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Accrual

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Informed Consent Comprehension

    Time frame: 12 weeks

    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.

  2. Voluntariness

    Time frame: 12 weeks

    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.

  3. Decision-Making Self-Efficacy

    Time frame: 12 weeks

    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.

  4. Decisional Regret

    Time frame: 12 weeks

    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.

  5. Satisfaction with informed consent

    Time frame: 12 weeks

    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.

  6. Trust in Research

    Time frame: 12 Weeks

    Assesses individual's views on research studies.

Other outcomes

  1. Acceptability (parents)

    Time frame: Year 1-Year 5

    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%

  2. Acceptability (clinicians)

    Time frame: Year 1-Year 5

    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%

  3. Feasibility

    Time frame: Year 1-Year 5

    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%.

  4. Fidelity

    Time frame: Year 1-Year 5

    Fidelity will be assessed by measuring adherence to the fidelity navigator checklist. Our fidelity goal is >90%.

Study contacts

Contact information is provided by the study sponsor or research team.

M.Paula Aristizabal, MD, MAS

CONTACT

[email protected]

858-966-5811

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

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

Registry information

Official study title

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

Acronym: COMPRENDO

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Sep 26, 2023
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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