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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
115
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.
Standard clinical visit for genetic counseling and follow up
Emory University School of Medicine
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States
Percentage of Consenting AYA use AYA-RISE
The feasibility (\>70% consenting AYAs use AYA-RISE through the risk communication step of the chat and patient portal, based on use data from Clear Genetics)
Time frame: 2 years
Percentage of Acceptability
Acceptability (\>70% AYAs consider the intervention acceptable, measured as a post-test AIM score \>4.)
Time frame: 2 years
Change in patient knowledge of cancer risk and screening
This change will be measured by baseline and post-visit survey responses on the Knowledge of Cancer Screening and Gist Comprehension of Genetic Cancer Risk measures.
Time frame: baseline to post-visit surveys up to 24 months
Change in psychological distress
This change will be measured by baseline and post-visit survey responses using the psychosocial aspects of hereditary cancer (PAHC) measure.
Time frame: baseline to post-visit surveys up to 24 months
Patient ownership of information in the intervention arm
determined as % AYAs able to store and access portal information
Time frame: 24 Months
Participants who followed up for recommended care
We will identify recommended care and screening via medical record review, and whether care was received, post-visit.
Time frame: screening and follow-up over the next year up to 24 Months
Utilization of AYA-RISE
Chat transcripts and patient portal access
Time frame: 2 Years
Acceptability of AYA-RISE
Semi-structured interview: How did patients, providers, family members feel about the intervention? Was the experience positive, negative, or neutral? An analytic matrix on intervention design will be used to code of semi-structured interviews
Time frame: 2 Years
Adoption of AYA-RISE
An analytic matrix on intervention design will be used to code of semi-structured interviews \- Semi-structured interview of Providers and Clinic Leaders * Were patients and providers willing to try the intervention? * Would they want to continue to use the intervention?
Time frame: 2 Years
Practicality of Using AYA-RISE
An analytic matrix on intervention design will be used to code of semi-structured interviews: Site PI Semi-structured interview * Is it practical to continue to use AYA-RISE within constraints of * clinic, provider, and patient/family needs?
Time frame: 2 Years
Fidelity of AYA-RISE
* Site RA: Observation and Checklist * Does actual implementation match the planned process?
Time frame: 2 Years
Sustainability of AYA-Rise
An analytic matrix on intervention design will be used to code of semi-structured interviews Can the processes required for AYA-RISE be maintained beyond the research setting?
Time frame: 2 Years
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