Multisite Implementation of COMPRENDO

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of California, San Diego
Study ID
NCT06055296
Status
Recruiting
Apply to this trial

Conditions

  • Pediatric Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 11, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.
  • 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.

Primary Outcome Measure

Accrual [ Time Frame: 12 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Children's of Alabama/University of Alabama at BirminghamBirminghamAlabama35243
Julie A Wolfson, MD, MSHS
[email protected]
205-638-9285
Rady Children's Hospital San Diego/University of California San Diego Moores Cancer CenterSan DiegoCalifornia92123
M.Paula Aristizabal, MD, MAS
[email protected]
858-966-5811
University of California San Francisco Benioff Children's HospitalsSan FranciscoCalifornia94609
Lena Winestone, MD, MHSP
[email protected]
415-476-2188
Dana Farber Cancer Institute/Boston Children's HospitalBostonMassachusetts02115
Kira Bona, MD, MPH
[email protected]
617-632-4688

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By research site
Children's of Alabama/University of Alabama at Birmingham· Birmingham, ALRady Children's Hospital San Diego/University of California San Diego Moores Cancer Center· San Diego, CAUniversity of California San Francisco Benioff Children's Hospitals· San Francisco, CADana Farber Cancer Institute/Boston Children's Hospital· Boston, MA

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