NCT04323774Active, not recruiting
Intervention For Adolescents and Young Adults (AYAs) With Cancer Risk Syndromes
AYA-RISE: Refining a Scalable, Patient- and Family-centered Intervention to Improve Cancer Risk Communication and Decision-making Among Adolescents and Young Adults With Cancer Risk Syndromes
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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 using a chatbot and online portal for cancer risk information helps improve communication and decision-making. * Over 70,000 adolescents and young adults (AYAs) are diagnosed with cancer in the U.S. every year and up to 10% have genetic changes (or, mutations) that put them at a higher risk of developing new cancers during their lifetimes. These genetic mutations can result in cancer risk syndromes (such as, Lynch Syndrome or Li-Fraumeni Syndrome). Identifying cancer risk syndromes can allow for screening and early diagnosis of future cancers, which could ultimately save lives and offer more care choices for patients. As a result, genetic counseling and testing for cancer risk syndromes is being recommended more for Adolescents and Young Adults with new cancer diagnoses, regardless of family history. * This research study to develop an intervention called AYA-RISE that aims to assist AYAs with cancer risk communication and decision-making around their caregivers.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 115 (actual)
- First submitted
- 23 Mar 2020
- Start date
- 1 Mar 2021
- Primary completion date
- 11 Jul 2025
- Lead sponsor
- Dana-Farber Cancer Institute
- Diseases
- Childhood cancers
- NCT number
- NCT04323774
What you commit to
- Study type: Interventional
- Participants enrolled: 115
- From 1 Mar 2021 to the primary completion date, 11 Jul 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 12 years to 24 years · Sex: All · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University School of Medicine Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Utah - Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
Related publications
- Chatbot Intervention and Cancer Risk Knowledge in Adolescents and Young Adults With Cancer Predisposition: A Randomized Clinical Trial.JAMA Netw Open · 2026 · PMID 42842248
This page is information, not medical advice. Discuss any trial with your doctor.