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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 24
Healthy Volunteers: t
View:

• 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

Locations
United States
Georgia
Emory University School of Medicine
RECRUITING
Atlanta
Illinois
University of Chicago
RECRUITING
Chicago
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Dana Farber Cancer Institute
RECRUITING
Boston
Utah
University of Utah, Huntsman Cancer Institute
RECRUITING
Salt Lake City
Contact Information
Primary
Jennifer Mack, MD
JMACK@PARTNERS.ORG
(617) 632-6622
Time Frame
Start Date: 2021-03-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 354
Treatments
No_intervention: Aim 1-Part 1 Stakeholder Interview
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
Experimental: Aim 1-Part 2
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
Active_comparator: Aim 2-Genetic Counseling
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.
Experimental: Aim 2- Genetic Counseling with AYA-RISE
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.
No_intervention: Aim 3 Semi-structured interviews
Each site will conduct 30-minute interviews with patients, caregivers, and providers, and site principal investigators.
Related Therapeutic Areas
Sponsors
Leads: Dana-Farber Cancer Institute
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov