Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Risk Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AYA-RISE Adolescents and Young Adults Risk Information and Screening Education | Behavioral | — | UNRESOLVED |
| Standard clinical visit for genetic counseling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- NO_INTERVENTION
- label
- Aim 1-Part 1 Stakeholder Interview
- description
- This arm will focus on finding the best format for the study intervention (called AYA-RISE) whether AYA-RISE is easy to use; and whether patients, family caregivers, and providers find AYA-RISE acceptable. The research study procedures include: * Using and reviewing AYA-RISE * Participating in audio-recorded, 30-minute interviews
- type
- EXPERIMENTAL
- label
- Aim 1-Part 2
- description
- This arm is a pilot study of the study intervention (called AYA-RISE). The activities involved in this part of the study are: * Baseline Questionnaire * Using and reviewing AYA-RISE * Follow-up Questionnaire * Brief interviews to get feedback on AYA-RISE
- interventionNames
- Behavioral: AYA-RISE Adolescents and Young Adults Risk Information and Screening Education
- type
- ACTIVE_COMPARATOR
- label
- Aim 2-Genetic Counseling
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 24 Years
Show eligibility criteria text
Inclusion Criteria: * Across all study aims, we will enroll AYA patients, family members/caregivers, and providers. AIM 1, PART 1 - STAKEHOLDER INTERVIEWS AYA Patients 1. Ages 12-24 years, inclusive 2. Diagnosed with a cancer risk syndrome 3. English-speaking and -reading 4. Receiving care at any of the study sites OR participating in the LiFraumeni Syndrome Association (LFSA) Youth Conference 5. Adequate cognitive function per NeuroQOL indicated by a score of 30 or greater 6. Not receiving active cancer therapy Family caregivers-Inclusion Criteria 1. Parent/guardian, spouse/partner, or other family member who participates in the care of AYAs aged 12-24 with cancer risk syndromes 2. English-speaking and -reading 3. At any of the study sites Providers Inclusion Criteria (Oncologists, nurses, genetic counselors, social workers, or psychologists) 1. English-speaking and reading 2. Caring for AYAs aged 12-24 with cancer risk syndromes at any of the study sites AIM 1, PART 2 - INTERVENTION PILOT AYA Patients 1. Ages 12-24 years, inclusive 2. Diagnosed with a cancer risk syndrome 3. English-speaking and -reading 4. Receiving care at Dana-Farber Cancer Institute 5. Adequate cognitive function per NeuroQOL, indicated by a score of 30 or greater 6. Not receiving active cancer therapy 7. 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 1. Ages 12-24 years, inclusive 2. Diagnosed with a cancer risk syndrome 3. English-speaking and reading 4. Has a planned post-disclosure genetic counseling or follow-up visit at any of the study sites 5. Adequate cognitive function per NeuroQOL, indicated by a score of 30 or greater 6. Not receiving active cancer therapy 7. Did not participate in either part of Aim 1 (interview or pilot) Family caregivers 1. Parent/guardian, spouse/partner, or other family member who participates in the care of AYAs aged 12-24 with cancer risk syndromes 2. English-speaking and -reading 3. At any of the study sites 4. 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 1. Participated in the intervention arm of Aim 2, or 2. Is a site principal investigator at one of the 4 participating study sites
References
Publications (0)
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