Cancer Risk Syndrome Clinical Trial
— AYA-RISEOfficial title:
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 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.
| Status | Recruiting |
| Enrollment | 354 |
| Est. completion date | December 31, 2026 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 12 Years to 24 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Emory University School of Medicine | Atlanta | Georgia |
| United States | Boston Children's Hospital | Boston | Massachusetts |
| United States | Dana Farber Cancer Institute | Boston | Massachusetts |
| United States | University of Chicago | Chicago | Illinois |
| United States | University of Utah, Huntsman Cancer Institute | Salt Lake City | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Dana-Farber Cancer Institute | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Percentage of Acceptability | Acceptability (>70% AYAs consider the intervention acceptable, measured as a post-test AIM score >4.) | 2 years | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Patient ownership of information in the intervention arm | determined as % AYAs able to store and access portal information | 24 Months | |
| Primary | 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 | |
| Primary | Utilization of AYA-RISE | Chat transcripts and patient portal access | 2 Years | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Fidelity of AYA-RISE | Site RA: Observation and Checklist
Does actual implementation match the planned process? |
2 Years | |
| Primary | 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 |