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AYA-RISE Program for Cancer Syndromes (AYA-RISE Trial)

N/A
Recruiting
Led By Jennifer Mack, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
AYA Patients for AIM 1, PART 1 - STAKEHOLDER INTERVIEWS: Ages 12-24 years, diagnosed with a cancer risk syndrome, English-speaking and -reading, receiving care at study sites or participating in LFSA Youth Conference, adequate cognitive function per NeuroQOL (score of 30 or greater), not receiving active cancer therapy
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

AYA-RISE Trial Summary

This trial is testing whether using a chatbot and online portal for cancer risk information helps improve communication and decision-making.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves an educational intervention rather than medication, traditional side effects are not expected. However, participants may experience emotional or psychological responses when discussing sensitive information about their health risks.

AYA-RISE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am aged 12-24, have a cancer risk syndrome, speak English, and am not currently undergoing cancer treatment.

AYA-RISE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of AYA-RISE
Adoption of AYA-RISE
Change in patient knowledge of cancer risk and screening
+9 more

AYA-RISE Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Aim 2- Genetic Counseling with AYA-RISEExperimental Treatment1 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 2Experimental Treatment1 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 interviewsActive Control1 Intervention
Each site will conduct 30-minute interviews with patients, caregivers, and providers, and site principal investigators.
Group IV: Aim 2-Genetic CounselingActive Control1 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 InterviewActive Control1 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

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,077 Previous Clinical Trials
340,389 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,926,987 Total Patients Enrolled
Jennifer Mack, MDPrincipal Investigator - Dana-Farber Cancer Institute
Boston Children's Hospital, Dana-Farber Cancer Institute
Harvard Medical Sch (Medical School)
Children'S Hospital (Residency)
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

AYA-RISE Adolescents and Young Adults Risk Information and Screening Education Clinical Trial Eligibility Overview. Trial Name: NCT04323774 — N/A
Cancer Syndromes Research Study Groups: Aim 2- Genetic Counseling with AYA-RISE, Aim 3 Semi-structured interviews, Aim 2-Genetic Counseling, Aim 1-Part 2, Aim 1-Part 1 Stakeholder Interview
Cancer Syndromes Clinical Trial 2023: AYA-RISE Adolescents and Young Adults Risk Information and Screening Education Highlights & Side Effects. Trial Name: NCT04323774 — N/A
AYA-RISE Adolescents and Young Adults Risk Information and Screening Education 2023 Treatment Timeline for Medical Study. Trial Name: NCT04323774 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent has participation in the trial been successful?

"Affirmative. According to the data on clinicaltrials.gov, this medical experiment is currently enrolling patients and was initially posted on March 1st 2021. It has been updated most recently on April 25th 2022 and seeks 354 participants at 5 different sites across the country."

Answered by AI

Could I potentially participate in this scientific investigation?

"This clinical study seeks to enroll 354 youths aged 12-24, who are living with Syndrome. Other requirements include that they must not be receiving active cancer treatment and possess adequate cognitive function (as indicated by a NeuroQOL score of 30 or more). Additionally, patients may come from any of the participating medical sites or attend the LiFraumeni Syndrome Association's Youth Conference."

Answered by AI

How many sites are in operation for this trial?

"The study is welcoming enrolment from participants at University of Utah, Huntsman Cancer Institute in Salt Lake City, Boston Children's Hospital in Chicago, and the University of Chicago in Atlanta. Simultaneously there are five additional medical centres currently participating."

Answered by AI

Does this investigation accept participants above the age of 25?

"Patients between the ages of 12 and 24 years old may join this trial."

Answered by AI

What is the enrollment status of this trial?

"Affirmative. Indications on clinicaltrials.gov point to this trial as actively seeking out individuals for enrollment. The study was first posted on March 1st 2021 and revised most recently on April 25th 2022, with the goal of including 354 patients across 5 different sites."

Answered by AI
~71 spots leftby Dec 2024