Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
450 participants
INTERVENTIONAL
2024-01-11
2029-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Clinicians and parents of children with cancer who have participated in IC discussion for a cancer therapeutic clinical trial.
Exclusion Criteria
* 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 not participated in IC discussion for a cancer therapeutic clinical trial.
18 Years
ALL
Yes
Sponsors
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Dana-Farber Cancer Institute
OTHER
University of California, San Francisco
OTHER
University of Alabama at Birmingham
OTHER
National Cancer Institute (NCI)
NIH
University of California, San Diego
OTHER
Responsible Party
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M. Paula Aristizabal
Associate Professor of Clinical Pediatrics, Division of Pediatric Hematology/Oncology
Principal Investigators
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M.Paula Aristizabal, MD, MAS
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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Children's of Alabama/University of Alabama at Birmingham
Birmingham, Alabama, United States
Rady Children's Hospital San Diego/University of California San Diego Moores Cancer Center
San Diego, California, United States
University of California San Francisco Benioff Children's Hospitals
San Francisco, California, United States
Dana Farber Cancer Institute/Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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808092
Identifier Type: -
Identifier Source: org_study_id
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