NCT04323774

Intervention For 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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 12 Years – 24 Years
• Healthy volunteers: Accepted

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 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.

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; 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 * Aim 1, Part 2, which is a pilot study of the study intervention (called AYA-RISE). In this pilot study, the investigators are looking at whether AYA-RISE is easy to use and what participants think of it. \-- The activities involved in this part of the study are: * Baseline Questionnaire * Using and reviewing AYA-RISE * Follow-up Questionnaire * Brief feedback interviews on AYA-RISE * In Aim 2, participants will be randomized trial into one of two groups; * Group 1: Standard Genetic Counseling/follow-up visit or * Group 2 : Standard Genetic Counseling/follow-up visit and Access to AYA-Rise * Aim 3: Semi-Structured Interviews: * Evaluate implementation outcomes using 28 semi-structured interviews with patients, family members, providers, and site principal investigators

Conditions

• Cancer Risk Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	AYA-RISE Adolescents and Young Adults Risk Information and Screening Education	A chatbot is a computer program that can chat with humans. The text the chatbot uses to talk with humans was created by real people, but the chatbot itself is not a real person. A company called Clear Genetics developed the original chatbot and patient portal, and this study team customized it for this research study.
BEHAVIORAL	Standard clinical visit for genetic counseling	Standard clinical visit for genetic counseling and follow up

Timeline

• Start date: 2021-03-01
• Primary completion: 2025-07-11
• Completion: 2027-06-30
• First posted: 2020-03-27
• Last updated: 2025-12-12

Locations

5 sites across 1 country: United States