Multisite Implementation of COMPRENDO (ChildhOod Malignancy Peer REsearch NavigatiOn) to Improve Participation of Hispanic Children in Cancer Clinical Trials
University of California, San Diego
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.
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 administrato…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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 clinic…
Interventions
- OtherCOMPRENDO 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.
Locations (4)
- Children's of Alabama/University of Alabama at BirminghamBirmingham, Alabama
- Rady Children's Hospital San Diego/University of California San Diego Moores Cancer CenterSan Diego, California
- University of California San Francisco Benioff Children's HospitalsSan Francisco, California
- Dana Farber Cancer Institute/Boston Children's HospitalBoston, Massachusetts