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Behavioural Intervention
Peer Navigation for Pediatric Cancer (COMPRENDO Trial)
N/A
Waitlist Available
Led By M.Paula Aristizabal, MD, MAS
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- has a child aged 0 to 17 y with a new diagnosis of cancer or cancer-like disease (histiocytic disorders or myelodysplastic syndromes);
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 1-year 5
Awards & highlights
COMPRENDO Trial Summary
This trial will test the impact of a peer-navigation intervention vs. usual care on accrual to childhood cancer clinical trials and parental informed consent. It will also explore how to use this intervention in the real world.
Who is the study for?
This trial is for Hispanic parents or guardians with children aged 0-17 who have a new diagnosis of cancer or similar disease and are eligible for a therapeutic clinical trial. Participants must understand English or Spanish, agree to discuss informed consent, and not be planning to transfer care soon.Check my eligibility
What is being tested?
COMPRENDO tests a peer-navigation intervention against usual care in pediatric cancer cases. It aims to improve the number of families participating in trials and enhance informed consent outcomes through four visits by trained navigators.See study design
What are the potential side effects?
Since COMPRENDO involves non-medical peer support rather than drugs, it doesn't have typical side effects like medications do. However, there may be emotional or psychological impacts from participation that will be monitored.
COMPRENDO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child, aged 0-17, was recently diagnosed with cancer or a similar disease.
COMPRENDO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 1-year 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 1-year 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Accrual
Secondary outcome measures
Decision-Making Self-Efficacy
Decisional Regret
Informed Consent Comprehension
+2 moreOther outcome measures
Acceptability (clinicians)
Acceptability (parents)
Feasibility
+1 moreCOMPRENDO Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: COMPRENDO InterventionExperimental Treatment1 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.
Group II: Usual CareActive Control1 Intervention
Parents will participate in an informed consent conference with the oncologist to discuss treatment options for the child as per each institution's procedure.
Find a Location
Who is running the clinical trial?
Harvard UniversityOTHER
230 Previous Clinical Trials
474,175 Total Patients Enrolled
University of California, San DiegoLead Sponsor
1,122 Previous Clinical Trials
1,520,594 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,079 Previous Clinical Trials
340,527 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare centers in the city are hosting this clinical experiment?
"The current trial is taking place in four locations; San Diego, San Francisco, Boston as well as other sites. To minimize travel inconvenience for prospective participants, they are encouraged to select the closest clinic available."
Answered by AI
Is this research program currently recruiting participants?
"It appears that the clinical trial, first posted on January 1st 2024 and last updated on September 19th 2023 is not currently enrolling patients. However, 55 other medical studies are actively accepting participants at this time."
Answered by AI
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