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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer Risk Syndrome
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 115
- Locations
- 5
- Primary Endpoint
- Utilization of AYA-RISE
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
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.
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
Investigators
Jennifer Mack, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Utilization of AYA-RISE
Time Frame: 2 Years
Chat transcripts and patient portal access
Participants who followed up for recommended care
Time Frame: screening and follow-up over the next year up to 24 Months
We will identify recommended care and screening via medical record review, and whether care was received, post-visit.
Percentage of Consenting AYA use AYA-RISE
Time Frame: 2 years
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)
Percentage of Acceptability
Time Frame: 2 years
Acceptability (\>70% AYAs consider the intervention acceptable, measured as a post-test AIM score \>4.)
Change in patient knowledge of cancer risk and screening
Time Frame: baseline to post-visit surveys up to 24 months
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.
Change in psychological distress
Time Frame: baseline to post-visit surveys up to 24 months
This change will be measured by baseline and post-visit survey responses using the psychosocial aspects of hereditary cancer (PAHC) measure.
Patient ownership of information in the intervention arm
Time Frame: 24 Months
determined as % AYAs able to store and access portal information
Acceptability of AYA-RISE
Time Frame: 2 Years
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
Adoption of AYA-RISE
Time Frame: 2 Years
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?
Practicality of Using AYA-RISE
Time Frame: 2 Years
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?
Fidelity of AYA-RISE
Time Frame: 2 Years
* Site RA: Observation and Checklist * Does actual implementation match the planned process?
Sustainability of AYA-Rise
Time Frame: 2 Years
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?