AYA-RISE Program for Cancer Syndromes

(AYA-RISE Trial)

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

354 Participants Needed

Trial Summary

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 data supports the effectiveness of the AYA-RISE treatment for cancer syndromes?

The research highlights the importance of specialized programs for adolescents and young adults (AYAs) with cancer, emphasizing the need for tailored approaches to meet their unique needs. While specific effectiveness data for AYA-RISE is not provided, the development of AYA-specific cancer programs has been shown to address unmet needs and improve care delivery for this age group. ^{1 2 3 4 5}

Is the AYA-RISE Program for Cancer Syndromes safe for humans?

There is no specific safety data available for the AYA-RISE Program for Cancer Syndromes in the provided research articles. ^{1 3 4 6 7}

How is the AYA-RISE treatment different from other treatments for cancer syndromes?

The AYA-RISE treatment is unique because it focuses on increasing access to genetic counseling and testing for adolescents and young adults with cancer, addressing barriers that prevent them from utilizing these services. This approach is novel as it emphasizes early identification of genetic risks and personalized care, which can influence clinical management and family planning decisions. ^{1 3 4 5 8}

What is the purpose of this trial?

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.

Research Team

Jennifer Mack, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Collaborating with Adolescents and Young Adults with Cancer as Advisors. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Developing a Comprehensive Adolescent and Young Adult Cancer Program: Lessons Learned from 7 Years of Growth and Progress. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

A Review of Breast Cancer Risk Factors in Adolescents and Young Adults. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Exploring patient and provider perspectives on the intersection between fertility, genetics, and family building. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Factors impacting adolescent and young adult cancer patients' decision to pursue genetic counseling and testing. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Prevalence of Adverse Event Reporting in Adolescents and Young Adults Enrolled in Cancer Clinical Trials. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Is the Adolescent and Young Adult Cancer Survivor at Risk for Late Effects? It Depends on Where You Look. [2018]

8. United States 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. [2022]