AYA-RISE for the Improvement of Cancer Risk Communication and Decision-Making in Adolescents and Young Adults with Cancer Risk Syndromes

Active:	Yes
Cancer Type:	Cancer-Related Syndrome	NCT ID:	NCT04323774
Trial Phases:		Protocol IDs:	20-003 (primary) NCI-2020-03811
Eligibility:	12 Years and older, Male and Female	Study Type:	Health services research
Study Sponsor:	Dana-Farber Harvard Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT04323774

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.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.