Cancer Risk SyndromeAYA-RISENCT04323774

Intervention For Adolescents and Young Adults (AYAs) With Cancer Risk Syndromes

A study testing AYA-RISE Adolescents and Young Adults Risk Information and Screening Education and Standard clinical visit for genetic counseling in people with Cancer Risk Syndrome, run by Dana-Farber Cancer Institute at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 to 24 yearsHealthy volunteers can take part
Conditions the study is for: Cancer Risk Syndrome
What is being tested?: AYA-RISE Adolescents and Young Adults Risk Information and Screening Education and Standard clinical visit for genetic counseling
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 115 participants
Where: 5 sitesUnited States
Study dates: 1 Mar 2021to 30 Jun 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 24 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Show all 46Show fewer

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

Who cannot join

None listed.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Emory University School of Medicine
Atlanta, Georgia, 30342
Boston Children's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
University of Chicago
Chicago, Illinois, 60637
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

This research study involves three aims (Aims 1, 2, and 3).

Aim 1, Part 1, which focuses 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
Aim 1, Part 2, which is a pilot study of the study intervention (called AYA-RISE). In this pilot study, the investigators are looking at whether AYA-RISE is easy to use and what participants think of it. -- The activities involved in this part of the study are:
Baseline Questionnaire
Using and reviewing AYA-RISE
Follow-up Questionnaire
Brief feedback interviews on AYA-RISE
In Aim 2, participants will be randomized trial into one of two groups;
Group 1: Standard Genetic Counseling/follow-up visit or
Group 2 : Standard Genetic Counseling/follow-up visit and Access to AYA-Rise
Aim 3: Semi-Structured Interviews:
Evaluate implementation outcomes using 28 semi-structured interviews with patients, family members, providers, and site principal investigators

Conditions: Cancer Risk Syndrome
Being tested: AYA-RISE Adolescents and Young Adults Risk Information and Screening Education, Standard clinical visit for genetic counseling
Keywords: Cancer Risk Syndrome, LiFraumeni Syndrome Association (LFSA) Youth Conference

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AYA-RISE Adolescents and Young Adults Risk Information and Screening EducationBehavioural
Also called AYA-RISE
A chatbot is a computer program that can chat with humans. The text the chatbot uses to talk with humans was created by real people, but the chatbot itself is not a real person. A company called Clear Genetics developed the original chatbot and patient portal, and this study team customized it for this research study.
Standard clinical visit for genetic counselingBehavioural
Standard clinical visit for genetic counseling and follow up

Study groups in NCT04323774
Study group	Role	What they receive
Aim 1-Part 1 Stakeholder Interview	No 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
Aim 1-Part 2	Experimental	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 Receives: Behavioral: AYA-RISE Adolescents and Young Adults Risk Information and Screening Education
Aim 2-Genetic Counseling	Active comparator	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. Receives: Behavioral: Standard clinical visit for genetic counseling
Aim 2- Genetic Counseling with AYA-RISE	Experimental	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. Receives: Behavioral: AYA-RISE Adolescents and Young Adults Risk Information and Screening Education
Aim 3 Semi-structured interviews	No intervention	Each site will conduct 30-minute interviews with patients, caregivers, and providers, and site principal investigators.

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Consenting AYA use AYA-RISE
The feasibility (>70% consenting AYAs use AYA-RISE through the risk communication step of the chat and patient portal, based on use data from Clear Genetics)
Measured: 2 years
Percentage of Acceptability
Acceptability (>70% AYAs consider the intervention acceptable, measured as a post-test AIM score >4.)
Measured: 2 years
Change in patient knowledge of cancer risk and screening
This change will be measured by baseline and post-visit survey responses on the Knowledge of Cancer Screening and Gist Comprehension of Genetic Cancer Risk measures.
Measured: baseline to post-visit surveys up to 24 months
Change in psychological distress
This change will be measured by baseline and post-visit survey responses using the psychosocial aspects of hereditary cancer (PAHC) measure.
Measured: baseline to post-visit surveys up to 24 months
Patient ownership of information in the intervention arm
determined as % AYAs able to store and access portal information
Measured: 24 Months
Participants who followed up for recommended care
We will identify recommended care and screening via medical record review, and whether care was received, post-visit.
Measured: screening and follow-up over the next year up to 24 Months
Utilization of AYA-RISE
Chat transcripts and patient portal access
Measured: 2 Years
Acceptability of AYA-RISE
Semi-structured interview: How did patients, providers, family members feel about the intervention? Was the experience positive, negative, or neutral? An analytic matrix on intervention design will be used to code of semi-structured interviews
Measured: 2 Years
Adoption of AYA-RISE
An analytic matrix on intervention design will be used to code of semi-structured interviews
- Semi-structured interview of Providers and Clinic Leaders
- Were patients and providers willing to try the intervention?
- Would they want to continue to use the intervention?
Measured: 2 Years
Practicality of Using AYA-RISE
An analytic matrix on intervention design will be used to code of semi-structured interviews: Site PI Semi-structured interview
- Is it practical to continue to use AYA-RISE within constraints of
- clinic, provider, and patient/family needs?
Measured: 2 Years
Fidelity of AYA-RISE
- Site RA: Observation and Checklist
- Does actual implementation match the planned process?
Measured: 2 Years
Sustainability of AYA-Rise
An analytic matrix on intervention design will be used to code of semi-structured interviews Can the processes required for AYA-RISE be maintained beyond the research setting?
Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202130 Jun 2027

First posted27 Mar 2020
Study start1 Mar 2021
Primary completion11 Jul 2025
Study completion30 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cancer Risk SyndromeStudies of the same condition, open and under way.
More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04323774
Sponsor's protocol ID: 20-003
Other IDs: U01CA243688-01
Acronym: AYA-RISE
Status last verified: Jul 2026
First submitted: 23 Mar 2020
Last updated: 29 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Publications

Kamihara J, Cronin AM, Uno H, Horiguchi M, Fisher L, Schienda J, Vanderwall R, Snir M, Snir G, Simmons E, Khalaj A, Goler E, Hamilton KV, Porter CC, Pencheva B, Schiffman JD, Maese LD, Kohlmann WK, Henderson TO, Garber JE, Diller LR, Desai AV, Feola S, Johnson DL, Rodriguez SM, Vagher J, Mehrhoff CJ, Savage S, Perry J, Glorioso M, Moyer N, Klosky JL, Rana HQ, Mack JW. Chatbot Intervention and Cancer Risk Knowledge in Adolescents and Young Adults With Cancer Predisposition: A Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2635794. doi: 10.1001/jamanetworkopen.2026.35794.
PubMed 42842248

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cancer Risk Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04323774
Acronym / sponsor ID: AYA-RISE / 20-003
Conditions: Cancer Risk Syndrome
Keywords: Cancer Risk Syndrome, LiFraumeni Syndrome Association (LFSA) Youth Conference
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 115 participants (actual)
Lead sponsor: Dana-Farber Cancer InstituteUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 1 Mar 2021 (actual)
Primary completion: 11 Jul 2025 (actual)
Study completion: 30 Jun 2027 (estimated)
First posted: 27 Mar 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

This research study involves three aims (Aims 1, 2, and 3).

Aim 1, Part 1, which focuses 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
Aim 1, Part 2, which is a pilot study of the study intervention (called AYA-RISE). In this pilot study, the investigators are looking at whether AYA-RISE is easy to use and what participants think of it. -- The activities involved in this part of the study are:
Baseline Questionnaire
Using and reviewing AYA-RISE
Follow-up Questionnaire
Brief feedback interviews on AYA-RISE
In Aim 2, participants will be randomized trial into one of two groups;
Group 1: Standard Genetic Counseling/follow-up visit or
Group 2 : Standard Genetic Counseling/follow-up visit and Access to AYA-Rise
Aim 3: Semi-Structured Interviews:
Evaluate implementation outcomes using 28 semi-structured interviews with patients, family members, providers, and site principal investigators

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Aim 1-Part 1 Stakeholder Interview	No 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
Aim 1-Part 2	Experimental	Behavioral: AYA-RISE Adolescents and Young Adults Risk Information and Screening EducationThis 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
Aim 2-Genetic Counseling	Active comparator	Behavioral: Standard clinical visit for genetic counselingThe 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.
Aim 2- Genetic Counseling with AYA-RISE	Experimental	Behavioral: AYA-RISE Adolescents and Young Adults Risk Information and Screening EducationThe 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.
Aim 3 Semi-structured interviews	No intervention	–Each site will conduct 30-minute interviews with patients, caregivers, and providers, and site principal investigators.

Who may qualify

Ages: 12 to 24 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (46 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AYA-RISE Adolescents and Young Adults Risk Information and Screening EducationAlso: AYA-RISEA chatbot is a computer program that can chat with humans. The text the chatbot uses to talk with humans was created by real people, but the chatbot itself is not a real person. A company called Clear Genetics developed the original chatbot and patient portal, and this study team customized it for this research study.	Behavioural	Aim 1-Part 2, Aim 2- Genetic Counseling with AYA-RISE
Standard clinical visit for genetic counselingStandard clinical visit for genetic counseling and follow up	Behavioural	Aim 2-Genetic Counseling

Primary outcome

Percentage of Consenting AYA use AYA-RISE
Time frame: 2 years
The feasibility (>70% consenting AYAs use AYA-RISE through the risk communication step of the chat and patient portal, based on use data from Clear Genetics)
Percentage of Acceptability
Time frame: 2 years
Acceptability (>70% AYAs consider the intervention acceptable, measured as a post-test AIM score >4.)
Change in patient knowledge of cancer risk and screening
Time frame: baseline to post-visit surveys up to 24 months
This change will be measured by baseline and post-visit survey responses on the Knowledge of Cancer Screening and Gist Comprehension of Genetic Cancer Risk measures.
Change in psychological distress
Time frame: baseline to post-visit surveys up to 24 months
This change will be measured by baseline and post-visit survey responses using the psychosocial aspects of hereditary cancer (PAHC) measure.
Patient ownership of information in the intervention arm
Time frame: 24 Months
determined as % AYAs able to store and access portal information
Participants who followed up for recommended care
Time frame: screening and follow-up over the next year up to 24 Months
We will identify recommended care and screening via medical record review, and whether care was received, post-visit.
Utilization of AYA-RISE
Time frame: 2 Years
Chat transcripts and patient portal access
Acceptability of AYA-RISE
Time frame: 2 Years
Semi-structured interview: How did patients, providers, family members feel about the intervention? Was the experience positive, negative, or neutral? An analytic matrix on intervention design will be used to code of semi-structured interviews
Adoption of AYA-RISE
Time frame: 2 Years
An analytic matrix on intervention design will be used to code of semi-structured interviews - Semi-structured interview of Providers and Clinic Leaders * Were patients and providers willing to try the intervention? * Would they want to continue to use the intervention?
Practicality of Using AYA-RISE
Time frame: 2 Years
An analytic matrix on intervention design will be used to code of semi-structured interviews: Site PI Semi-structured interview * Is it practical to continue to use AYA-RISE within constraints of * clinic, provider, and patient/family needs?
Fidelity of AYA-RISE
Time frame: 2 Years
* Site RA: Observation and Checklist * Does actual implementation match the planned process?
Sustainability of AYA-Rise
Time frame: 2 Years
An analytic matrix on intervention design will be used to code of semi-structured interviews Can the processes required for AYA-RISE be maintained beyond the research setting?

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
Derived from this study: PubMed 42842248Kamihara J, Cronin AM, Uno H, Horiguchi M, Fisher L, Schienda J, Vanderwall R, Snir M, Snir G, Simmons E, Khalaj A, Goler E, Hamilton KV, Porter CC, Pencheva B, Schiffman JD, Maese LD, Kohlmann WK, Henderson TO, Garber JE, Diller LR, Desai AV, Feola S, Johnson DL, Rodriguez SM, Vagher J, Mehrhoff CJ, Savage S, Perry J, Glorioso M, Moyer N, Klosky JL, Rana HQ, Mack JW. Chatbot Intervention and Cancer Risk Knowledge in Adolescents and Young Adults With Cancer Predisposition: A Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2635794. doi: 10.1001/jamanetworkopen.2026.35794.
Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer Mack, MD principal investigator

Dana-Farber Cancer Institute

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 46 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Consenting AYA use AYA-RISE (time frame: 2 years). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04323774, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.