Clinical trial NCT06055296: Multisite Implementation of COMPRENDO
Official title: Multisite Implementation of COMPRENDO (ChildhOod Malignancy Peer REsearch NavigatiOn) to Improve Participation of Hispanic Children in Cancer Clinical Trials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Keywords: Research Literacy
Cancer Disparities
Minority Clinical Trial Accrual
Patient Navigation
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: University of California, San Francisco
name: University of Alabama at Birmingham
name: National Cancer Institute (NCI)
First posted: 2023-09-26
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Accrual
timeFrame: 12 weeks
Secondary outcomes:
measure: Informed Consent Comprehension
timeFrame: 12 weeks
measure: Voluntariness
timeFrame: 12 weeks
measure: Decision-Making Self-Efficacy
timeFrame: 12 weeks
measure: Decisional Regret
timeFrame: 12 weeks
measure: Satisfaction with informed consent
timeFrame: 12 weeks
Other outcomes:
measure: Acceptability (parents)
timeFrame: Year 1-Year 5
measure: Acceptability (clinicians)
timeFrame: Year 1-Year 5
measure: Feasibility
timeFrame: Year 1-Year 5
measure: Fidelity
timeFrame: Year 1-Year 5
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama/University of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego/University of California San Diego Moores Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Benioff Children's Hospitals
state: California
city: Boston
country: United States
facility: Dana Farber Cancer Institute/Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: University of California, San Diego
name: M.Paula Aristizabal, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.