Summary

This early phase I trial studies how well using a patient- and family-centered intervention called Adolescents and Young Adults-Risk Information and Screening Education (AYA-RISE) works in improving cancer risk communication and decision-making in AYAs with cancer risk syndromes. Cancer risk syndromes result from genetic changes (or, mutations) that put patients at higher risk of developing new cancers during their lifetime. Identifying cancer risk syndromes may allow for screening and early diagnosis of future cancers, which may offer more care choices for patients. As a result, genetic counseling and testing for cancer risk syndromes is being recommended more for AYAs with cancer. AYA-RISE is a web-based intervention comprised of a chatbot to communicate genetic information and an individualized patient portal that serves as a resource for cancer and screening risk information. The goal of AYA-RISE, and the purpose of this study, is to assist AYAs with communicating about cancer risk and decision-making around their care.

Objectives

PRIMARY OBJECTIVES:
I. To refine and pilot AYA-RISE, adapting implementation to ensure feasibility and acceptability.
II. To implement the AYA-RISE intervention as a randomized trial in 4 sites.
III. To evaluate implementation outcomes of AYA-RISE to facilitate future dissemination.

OUTLINE:

AIM I, PART I: Patients, caregivers, and providers use AYA-RISE, then participate in an audio-recorded interview over 30 minutes about their thoughts of AYA-RISE.

AIM I, PART II: Patients complete a questionnaire at baseline about what they already know about cancer risk syndromes and how they feel, then use AYA-RISE. Patients then complete a follow-up questionnaire and participate in an audio-recorded interview. Caregivers may also complete both questionnaires and use AYA-RISE.

AIM II: Patients are randomized to 1 of 2 arms.

ARM I: Patients complete a questionnaire at baseline. Patients attend their standard of care clinic visit for genetic counseling or other follow-up, then complete a follow-up questionnaire. Patients' medical records are also reviewed at baseline and 13 months post-visit to identify care received.

ARM II: Patients complete a questionnaire at baseline. Patients attend their standard of care clinic visit for genetic counseling or other follow-up, and are given access to AYA-RISE. Patients then complete a follow-up questionnaire at 12 months post-visit, and their medical records are reviewed at baseline and 13 months post-visit to identify care received.

AIM III: Patients, caregivers, providers, and site principal investigators participate in an audio-recorded interview over 30 minutes.

Eligibility

1. AIM I, PART I - AYA PATIENTS: Ages 12-24 years, inclusive
2. AIM I, PART I - AYA PATIENTS: Diagnosed with a cancer risk syndrome
3. AIM I, PART I - AYA PATIENTS: English-speaking and -reading
4. AIM I, PART I - AYA PATIENTS: Receiving care at any of the study sites OR participating in the Li-Fraumeni Syndrome Association (LFSA) Youth Conference
5. AIM I, PART I - AYA PATIENTS: Adequate cognitive function per Quality of Life in Neurological Disorders (NeuroQOL) indicated by a score of 30 or greater
6. AIM I, PART I - AYA PATIENTS: Not receiving active cancer therapy
7. AIM I, PART I - FAMILY CAREGIVERS: Parent/guardian, spouse/partner, or other family member who participates in the care of AYAs aged 12-24 with cancer risk syndromes
8. AIM I, PART I - FAMILY CAREGIVERS: English-speaking and -reading
9. AIM I, PART I - FAMILY CAREGIVERS: At any of the study sites
10. AIM I, PART I - PROVIDERS: Oncologists, nurses, genetic counselors, social workers, or psychologists
11. AIM I, PART I - PROVIDERS: English-speaking and -reading
12. AIM I, PART I - PROVIDERS: Caring for AYAs aged 12-24 with cancer risk syndromes at any of the study sites
13. AIM I, PART II - AYA PATIENTS: Ages 12-24 years, inclusive
14. AIM I, PART II - AYA PATIENTS: Diagnosed with a cancer risk syndrome
15. AIM I, PART II - AYA PATIENTS: English-speaking and -reading
16. AIM I, PART II - AYA PATIENTS: Receiving care at Dana-Farber Cancer Institute
17. AIM I, PART II - AYA PATIENTS: Adequate cognitive function per NeuroQOL, indicated by a score of 30 or greater
18. AIM I, PART II - AYA PATIENTS: Not receiving active cancer therapy
19. AIM I, PART II - AYA PATIENTS: Did not participate in a stakeholder interview (Aim 1, Part 1)
20. AIM I, PART II - FAMILY CAREGIVERS: Parent/guardian, spouse/partner, or other family member who participates in the care of AYAs aged 12-24 with cancer risk syndromes
21. AIM I, PART II - FAMILY CAREGIVERS: English-speaking and -reading
22. AIM I, PART II - FAMILY CAREGIVERS: Must be participating in care of AYA patient at Dana-Farber Cancer Institute
23. AIM II - AYA PATIENTS: Ages 12-24 years, inclusive
24. AIM II - AYA PATIENTS: Diagnosed with a cancer risk syndrome
25. AIM II - AYA PATIENTS: English-speaking and -reading
26. AIM II - AYA PATIENTS: Has a planned post-disclosure genetic counseling or follow-up visit at any of the study sites
27. AIM II - AYA PATIENTS: Adequate cognitive function per NeuroQOL, indicated by a score of 30 or greater
28. AIM II - AYA PATIENTS: Not receiving active cancer therapy
29. AIM II - AYA PATIENTS: Did not participate in either part of Aim 1 (interview or pilot)
30. AIM II - FAMILY CAREGIVERS: Parent/guardian, spouse/partner, or other family member who participates in the care of AYAs aged 12-24 with cancer risk syndromes
31. AIM II - FAMILY CAREGIVERS: English-speaking and -reading
32. AIM II - FAMILY CAREGIVERS: At any of the study sites
33. AIM II - FAMILY CAREGIVERS: Did not participate in either part of Aim 1 (interview or pilot)
34. AIM III AYA PATIENTS, FAMILY CAREGIVERS, PROVIDERS, AND STUDY TEAM MEMBERS: AYA patient, family member, or provider who participated in the intervention arm of Aim 2, or,
35. AIM III AYA PATIENTS, FAMILY CAREGIVERS, PROVIDERS, AND STUDY TEAM MEMBERS: Is a site principal investigator at one of the 4 participating study sites, or
36. AIM III AYA PATIENTS, FAMILY CAREGIVERS, PROVIDERS, AND STUDY TEAM MEMBERS: Is a provider and/or clinic leader at one of the 4 participating study sites, or
37. AIM III AYA PATIENTS, FAMILY CAREGIVERS, PROVIDERS, AND STUDY TEAM MEMBERS: Is a member of the study team at one of the 4 participating study sites