AYA-RISE Program for Cancer Syndromes

(AYA-RISE Trial)

Not currently recruiting at 4 trial locations

Overseen By Jennifer Mack, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Active cancer therapy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a chatbot and online portal can help young people understand their genetic cancer risks and make informed decisions. It focuses on adolescents and young adults with genetic mutations that increase their risk of developing new cancers, such as Lynch Syndrome or Li-Fraumeni Syndrome. Participants will use a tool called AYA-RISE (Adolescents and Young Adults Risk Information and Screening Education) to determine if it improves communication and decision-making about their health. Those diagnosed with a cancer risk syndrome and not currently undergoing active cancer treatment might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future health communication tools.

Do I need to stop my current medications for the AYA-RISE trial?

The trial information does not specify whether you need to stop taking your current medications. However, since participants should not be receiving active cancer therapy, it might be best to discuss your specific medications with the study team.

What prior data suggests that the AYA-RISE program is safe for improving cancer risk communication and decision-making?

Research shows that the AYA-RISE program can help young people with cancer better understand their risks. This program aims to improve communication about cancer risks by providing clear and helpful information to teens and young adults who might have genetic changes that increase their risk for cancer.

Regarding safety, this educational tool differs from taking a new medicine. There is no risk of physical harm from using the AYA-RISE program, as it focuses on learning about health. As an educational program, it has not been associated with side effects like those found with medications.

Overall, the AYA-RISE program is considered safe for participants. It focuses on providing young people with knowledge and helping them make informed health decisions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AYA-RISE program because it offers a fresh approach to genetic counseling and education for adolescents and young adults with cancer syndromes. Unlike traditional genetic counseling, which typically focuses on assessing family history and genetic risk, AYA-RISE incorporates a comprehensive education component designed to empower patients with tailored risk information and screening strategies. This personalized educational aspect aims to enhance patient understanding and engagement, potentially leading to better health outcomes. Additionally, by integrating this intervention into standard clinical visits, AYA-RISE seeks to streamline the process, making it more accessible and less time-consuming for patients.

What evidence suggests that the AYA-RISE program is effective for improving cancer risk communication and decision-making among adolescents and young adults?

Studies have shown the importance of improving communication and decision-making about cancer risk for teenagers and young adults with genetic conditions that increase their cancer risk. These conditions, caused by genetic changes, can raise the likelihood of developing new cancers. This trial will compare the AYA-RISE program, designed to help these young people and their families understand and manage these risks, with standard genetic counseling. While specific data on AYA-RISE's effectiveness is still being collected, the program aims to support clearer communication and informed decision-making about cancer risks. Early signs suggest that such programs can empower patients and may lead to earlier cancer detection and treatment. ^{1 2 4 6 7}

Who Is on the Research Team?

Jennifer Mack, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults aged 12-24 with cancer risk syndromes, their family caregivers, and healthcare providers. Participants must speak English and have good cognitive function. They should not be receiving active cancer therapy or have taken part in certain parts of the study before.

Inclusion Criteria

I am aged 12-24, have a cancer risk syndrome, speak English, and am not currently undergoing cancer treatment.

AYA Patients for AIM 3 - SEMI-STRUCTURED INTERVIEWS: Participated in the intervention arm of Aim 2, or is a site principal investigator at one of the 4 participating study sites

I am aged 12-24, have a cancer risk syndrome, speak English, and am not on active cancer therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Participants use and review AYA-RISE, participate in interviews to find the best format for the intervention

Part of Aim 1

1 visit (in-person)

Pilot Study

Pilot study of AYA-RISE to assess usability and participant feedback

Part of Aim 1

1 visit (in-person)

Randomized Trial

Participants are randomized into groups for standard genetic counseling with or without AYA-RISE

Up to 1 year

Regularly scheduled clinic visits

Follow-up

Participants are monitored for changes in knowledge, psychological distress, and follow-up care

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• AYA-RISE Adolescents and Young Adults Risk Information and Screening Education
• Standard clinical visit for genetic counseling

Trial Overview

The AYA-RISE intervention uses a chatbot and online portal to help improve communication and decision-making about cancer risks among young individuals with genetic mutations that increase their cancer risk. The effectiveness of this educational tool compared to standard genetic counseling visits is being studied.

How Is the Trial Designed?

Group I: Aim 2- Genetic Counseling with AYA-RISE Experimental Treatment 1 Intervention

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.

Group II: Aim 1-Part 2 Experimental Treatment 1 Intervention

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

Group III: Aim 3 Semi-structured interviews Active Control 1 Intervention

Each site will conduct 30-minute interviews with patients, caregivers, and providers, and site principal investigators.

Group IV: Aim 2-Genetic Counseling Active Control 1 Intervention

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.

Group V: Aim 1-Part 1 Stakeholder Interview Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A review of 182 phase II/III cancer trials published in 2021 found that none reported adverse event (AE) data specifically for adolescents and young adults (AYAs) aged 15-39, making it impossible to assess their treatment tolerance compared to older adults.

The lack of age-specific AE reporting may hinder the optimization of cancer treatments for AYAs, potentially leading to either undertreatment or overtreatment, which could delay improvements in their cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of Adverse Event Reporting in Adolescents and Young Adults Enrolled in Cancer Clinical Trials. Wayant, C., Fitzgerald, K., Hemmerich, C., et al.[2023]

The Genetic Evaluation Initiative (GEI) significantly improved access to genetic counseling for adolescents and young adults (AYAs) with cancer, resulting in a 72% increase in utilization of genetic services among this population.

Out of 109 AYAs referred for genetic counseling, 64.2% were successfully referred, and 75.6% of those who met with a genetic counselor completed genetic testing, highlighting the effectiveness of the initiative in facilitating genetic evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Genetic Evaluation Initiative to Increase Access to Genetic Services for Adolescent and Young Adults at a Tertiary Cancer Hospital. Makhnoon, S., Corredor, J., Arun, B., et al.[2022]

The University of North Carolina's AYA Cancer Program, established in 2015, provides valuable insights and strategies for developing specialized cancer care for adolescents and young adults, addressing their unique physical and psychosocial needs.

The program's evolution highlights the importance of overcoming multilevel barriers in cancer care delivery, offering a model that other cancer centers can follow to improve services for this underserved population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Comprehensive Adolescent and Young Adult Cancer Program: Lessons Learned from 7 Years of Growth and Progress. Haines, ER., Lux, L., Stein, J., et al.[2023]

The development of a Young Adult Advisory Program specifically for adolescent and young adult (AYA) cancer patients is crucial for tailoring cancer care to meet their unique needs, as traditional advisory methods may not be effective.

The article shares insights on the program's reach and participant demographics, providing valuable lessons for other organizations aiming to involve AYAs in healthcare program development and quality improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborating with Adolescents and Young Adults with Cancer as Advisors. McGrady, ME., Norris, RE., Pai, ALH.[2020]

Adolescent and young adult cancer patients often feel overwhelmed by the information regarding fertility preservation (FP) and genetic testing/counseling (GT/GC), which can hinder their understanding and decision-making about future family building.

There is a need for improved educational materials, such as videos depicting patient-provider interactions, to help AYA patients better understand FP and GT/GC options and encourage them to ask relevant questions during clinical visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring patient and provider perspectives on the intersection between fertility, genetics, and family building. Lake, PW., Kasting, ML., Dean, M., et al.[2021]

There are over 600,000 adolescent and young adult cancer survivors at high risk for late effects from their treatments, highlighting the need for effective survivorship care plans (SCPs).

Current guidelines for AYA cancer survivorship care show significant disagreements on key aspects such as treatment exposure links to late effects and screening protocols, which can complicate follow-up care and impact the quality of life for survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the Adolescent and Young Adult Cancer Survivor at Risk for Late Effects? It Depends on Where You Look. Barthel, EM., Spencer, K., Banco, D., et al.[2018]

Adolescents and young adults (AYAs) with cancer experience worse disease-free and overall survival outcomes compared to younger children or older adults, highlighting the need for tailored clinical approaches for this age group.

Understanding the genetic predispositions and risk factors for AYA cancers, particularly breast cancer, can improve early detection strategies and inform reproductive decisions for affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Breast Cancer Risk Factors in Adolescents and Young Adults. McVeigh, UM., Tepper, JW., McVeigh, TP.[2021]

A study involving 30 adolescent and young adult cancer patients revealed that motivations for pursuing genetic counseling included concerns about hereditary cancer risks for themselves and their families, as well as the potential for improved cancer screening and prevention.

Barriers to accessing genetic counseling included scheduling conflicts, worries about the implications of testing, and costs; however, most participants expressed a willingness to reconsider genetic counseling in the future, indicating a persistent interest despite these challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors impacting adolescent and young adult cancer patients' decision to pursue genetic counseling and testing. Morand, M., Roth, M., Peterson, SK., et al.[2023]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04323774

Intervention For AYAS 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.

2.

dana-farber.org

dana-farber.org/clinical-trials/20-003

AYA-RISE: Refining a scalable, patient- and family ...

This research study to develop an intervention called AYA-RISE that aims to assist AYAs with cancer risk communication and decision-making around their ...

3.

withpower.com

withpower.com/trial/phase-syndrome-2-2021-37e0a

AYA-RISE Program for Cancer Syndromes

This trial is for adolescents and young adults aged 12-24 with cancer risk syndromes, their family caregivers, and healthcare providers. Participants must speak ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8152481/

Protocol of the Prospective Observational COMPRAYA Cohort ...

Adolescent and young adult (AYA) cancer patients suffer from delay in diagnosis, and lack of centralized cancer care, age-adjusted expertise, and follow-up care ...

5.

georgiacancerinfo.org

georgiacancerinfo.org/clinical-trials/detail/5270

AYA-RISE for the Improvement of Cancer Risk ...

This early phase I trial studies how well using a patient- and family-centered intervention called Adolescents and Young Adults-Risk Information and Screening ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8103533/

Adolescents and young adults (AYA) with cancer

Drugs are being used off-label in adolescents with little safety or efficacy data. Limited information about the biology of cancer in AYA and ...

7.

acsjournals.onlinelibrary.wiley.com

acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21637

Cancer statistics for adolescents and young adults, 2020

The authors analyzed population-based cancer incidence and mortality for AYAs in the United States by age group (ages 15-19, 20-29, and 30-39 years), sex, and ...