Improving cancer risk communication for adolescents and young adults
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
This study is testing a new online tool with a chatbot to help young people understand their cancer risks better and see if it works better than regular genetic counseling.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 354 (estimated) |
| Ages | 12 Years to 24 Years |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Locations | 5 sites (Atlanta, Georgia and 4 other locations) |
| Trial ID | NCT04323774 on ClinicalTrials.gov |
What this trial studies
This research focuses on enhancing cancer risk communication and decision-making among adolescents and young adults (AYAs) diagnosed with cancer risk syndromes. The study employs a novel intervention called AYA-RISE, which includes a chatbot and online portal to provide cancer risk information. Participants will be involved in interviews and questionnaires to assess the usability and acceptability of AYA-RISE. Additionally, the study will compare standard genetic counseling with the AYA-RISE intervention to evaluate its effectiveness in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents and young adults aged 12-24 who have been diagnosed with a cancer risk syndrome.
Not a fit: Patients currently undergoing active cancer therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve how AYAs understand and manage their cancer risk, leading to better health outcomes.
How similar studies have performed: Other studies have shown promise in using digital tools for health communication, suggesting that this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Atlanta, Georgia and 4 other locations
- Emory University School of Medicine — Atlanta, Georgia, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- University of Utah, Huntsman Cancer Institute — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Mack, MD — Dana-Farber Cancer Institute
- Study coordinator: Jennifer Mack, MD
- Email: JMACK@PARTNERS.ORG
- Phone: (617) 632-6622
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.