Intervention For AYAS With Cancer Risk Syndromes (AYA-RISE)
Cancer Risk Syndrome
About this trial
This is an interventional health services research trial for Cancer Risk Syndrome focused on measuring Cancer Risk Syndrome, LiFraumeni Syndrome Association (LFSA) Youth Conference
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
- 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
Providers Inclusion Criteria (Oncologists, nurses, genetic counselors, social workers, or psychologists)
- 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
AYA Patients
- Ages 12-24 years, inclusive
- Diagnosed with a cancer risk syndrome
- English-speaking and -reading
- Receiving care at Dana-Farber Cancer Institute
- Adequate cognitive function per NeuroQOL, indicated by a score of 30 or greater
- Not receiving active cancer therapy
- 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
- Ages 12-24 years, inclusive
- Diagnosed with a cancer risk syndrome
- English-speaking and reading
- Has a planned post-disclosure genetic counseling or follow-up visit at any of the study sites
- Adequate cognitive function per NeuroQOL, indicated by a score of 30 or greater
- Not receiving active cancer therapy
- Did not participate in either part of Aim 1 (interview or pilot)
Family caregivers
- 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
- 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
- Participated in the intervention arm of Aim 2, or
- Is a site principal investigator at one of the 4 participating study sites
Sites / Locations
- Emory University School of MedicineRecruiting
- University of ChicagoRecruiting
- Boston Children's HospitalRecruiting
- Dana Farber Cancer InstituteRecruiting
- University of Utah, Huntsman Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
No Intervention
Experimental
Active Comparator
Experimental
No Intervention
Aim 1-Part 1 Stakeholder Interview
Aim 1-Part 2
Aim 2-Genetic Counseling
Aim 2- Genetic Counseling with AYA-RISE
Aim 3 Semi-structured interviews
This 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
This 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
The 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.
The 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.
Each site will conduct 30-minute interviews with patients, caregivers, and providers, and site principal investigators.