Status:
ACTIVE_NOT_RECRUITING
Intervention For AYAS With Cancer Risk Syndromes
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cancer Risk Syndrome
Eligibility:
All Genders
12-24 years
Phase:
NA
Brief Summary
This research is being done because there is a need to improve cancer risk communication and decision-making among adolescents and young adults. In this study, the investigators are looking at whether...
Detailed Description
This research study involves three aims (Aims 1, 2, and 3). * Aim 1, Part 1, which focuses on finding the best format for the study intervention (called AYA-RISE); whether AYA-RISE is easy to use; an...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Across all study aims, we will enroll AYA patients, family members/caregivers, and providers.
- AIM 1, PART 1 - STAKEHOLDER INTERVIEWS
- AYA Patients
- Ages 12-24 years, inclusive
- Diagnosed with a cancer risk syndrome
- English-speaking and -reading
- Receiving care at any of the study sites OR participating in the LiFraumeni Syndrome Association (LFSA) Youth Conference
- Adequate cognitive function per NeuroQOL indicated by a score of 30 or greater
- Not receiving active cancer therapy
- Family caregivers-Inclusion Criteria
- Parent/guardian, spouse/partner, or other family member who participates in the care of AYAs aged 12-24 with cancer risk syndromes
- English-speaking and -reading
- At any of the study sites
- Providers Inclusion Criteria (Oncologists, nurses, genetic counselors, social workers, or psychologists)
- English-speaking and reading
- Caring for AYAs aged 12-24 with cancer risk syndromes at any of the study sites
- AIM 1, PART 2 - INTERVENTION PILOT
- AYA Patients
- Ages 12-24 years, inclusive
- Diagnosed with a cancer risk syndrome
- English-speaking and -reading
- Receiving care at Dana-Farber Cancer Institute
- Adequate cognitive function per NeuroQOL, indicated by a score of 30 or greater
- Not receiving active cancer therapy
- Did not participate in a stakeholder interview
- Eligibility notes:
- Family caregivers of participating 12-17y patients will be eligible to participate in the pilot
- 12-17y patients can participate without a family member if both the patient and family member agree.
- Patients 18-24y will have the option to participate with or without a family member.
- AIM 2 - RANDOMIZED TRIAL
- AYA Patients
- Ages 12-24 years, inclusive
- Diagnosed with a cancer risk syndrome
- English-speaking and reading
- Has a planned post-disclosure genetic counseling or follow-up visit at any of the study sites
- Adequate cognitive function per NeuroQOL, indicated by a score of 30 or greater
- Not receiving active cancer therapy
- Did not participate in either part of Aim 1 (interview or pilot)
- Family caregivers
- Parent/guardian, spouse/partner, or other family member who participates in the care of AYAs aged 12-24 with cancer risk syndromes
- English-speaking and -reading
- At any of the study sites
- Did not participate in either part of Aim 1 (interview or pilot)
- AIM 3 - SEMI-STRUCTURED INTERVIEWS AYA Patients, Family Caregivers, Providers, and Site PIs
- Participated in the intervention arm of Aim 2, or
- Is a site principal investigator at one of the 4 participating study sites
Exclusion
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2027
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04323774
Start Date
March 1 2021
End Date
June 30 2027
Last Update
December 12 2025
Active Locations (5)
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1
Emory University School of Medicine
Atlanta, Georgia, United States, 30342
2
University of Chicago
Chicago, Illinois, United States, 60637
3
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115