Intervention For Adolescents and Young Adults (AYAs) With Cancer Risk Syndromes
AYA-RISE
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
2 other identifiers
interventional
115
1 country
5
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2020
CompletedFirst Posted
Study publicly available on registry
March 27, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
ExpectedJuly 29, 2026
July 1, 2026
4.4 years
March 23, 2020
July 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
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)
2 years
Percentage of Acceptability
Acceptability (\>70% AYAs consider the intervention acceptable, measured as a post-test AIM score \>4.)
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.
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.
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
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.
screening and follow-up over the next year up to 24 Months
Utilization of AYA-RISE
Chat transcripts and patient portal access
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
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?
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?
2 Years
Fidelity of AYA-RISE
* Site RA: Observation and Checklist * Does actual implementation match the planned process?
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?
2 Years
Study Arms (5)
Aim 1-Part 1 Stakeholder Interview
NO INTERVENTIONThis 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
Aim 1-Part 2
EXPERIMENTALThis 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
Aim 2-Genetic Counseling
ACTIVE COMPARATORThe names of the study activities involved in this study are: * Baseline Questionnaire * Follow-up Questionnaire * Medical record review The study procedures will all take place on the day of the patient's regularly scheduled clinic visit. Participants will be in this research study for up to 1 year.
Aim 2- Genetic Counseling with AYA-RISE
EXPERIMENTALThe names of the study activities involved in this study are: * Baseline Questionnaire * Follow-up Questionnaire * Medical record review * Using the study intervention, AYA-RISE The study procedures will all take place on the day of the patient's regularly scheduled clinic visit. Participants will be in this research study for up to 1 year.
Aim 3 Semi-structured interviews
NO INTERVENTIONEach site will conduct 30-minute interviews with patients, caregivers, and providers, and site principal investigators.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
- 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
- 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
- +29 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (5)
Emory University School of Medicine
Atlanta, Georgia, 30342, United States
University of Chicago
Chicago, Illinois, 60637, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Mack, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 23, 2020
First Posted
March 27, 2020
Study Start
March 1, 2021
Primary Completion
July 11, 2025
Study Completion (Estimated)
June 30, 2027
Last Updated
July 29, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.