Intervention For AYAS With Cancer Risk Syndromes

NCT ID: NCT04323774

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2027-06-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

AYA-RISE Adolescents and Young Adults Risk Information and Screening Education

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Standard clinical visit for genetic counseling

Intervention Type: BEHAVIORAL

Standard clinical visit for genetic counseling and follow up

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.

Group Type: EXPERIMENTAL

AYA-RISE Adolescents and Young Adults Risk Information and Screening Education

Intervention Type: BEHAVIORAL

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.

Aim 3 Semi-structured interviews

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

AYA-RISE Adolescents and Young Adults Risk Information and Screening Education

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.

Intervention Type: BEHAVIORAL

Standard clinical visit for genetic counseling

Standard clinical visit for genetic counseling and follow up

Intervention Type: BEHAVIORAL

Other Intervention Names

AYA-RISE

Eligibility Criteria

Inclusion Criteria

• Across all study aims, we will enroll AYA patients, family members/caregivers, and providers.

AIM 1, PART 1 - STAKEHOLDER INTERVIEWS

AYA Patients

1. Ages 12-24 years, inclusive

2. Diagnosed with a cancer risk syndrome

3. English-speaking and -reading

4. Receiving care at any of the study sites OR participating in the LiFraumeni Syndrome Association (LFSA) Youth Conference

5. Adequate cognitive function per NeuroQOL indicated by a score of 30 or greater

6. Not receiving active cancer therapy

1. Parent/guardian, spouse/partner, or other family member who participates in the care of AYAs aged 12-24 with cancer risk syndromes

2. English-speaking and -reading

3. At any of the study sites

1. English-speaking and reading

2. Caring for AYAs aged 12-24 with cancer risk syndromes at any of the study sites

AIM 1, PART 2 - INTERVENTION PILOT

AYA Patients

1. Ages 12-24 years, inclusive

2. Diagnosed with a cancer risk syndrome

3. English-speaking and -reading

4. Receiving care at Dana-Farber Cancer Institute

5. Adequate cognitive function per NeuroQOL, indicated by a score of 30 or greater

6. Not receiving active cancer therapy

7. 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

1. Ages 12-24 years, inclusive

2. Diagnosed with a cancer risk syndrome

3. English-speaking and reading

4. Has a planned post-disclosure genetic counseling or follow-up visit at any of the study sites

5. Adequate cognitive function per NeuroQOL, indicated by a score of 30 or greater

6. Not receiving active cancer therapy

7. Did not participate in either part of Aim 1 (interview or pilot)

Family caregivers

1. Parent/guardian, spouse/partner, or other family member who participates in the care of AYAs aged 12-24 with cancer risk syndromes

2. English-speaking and -reading

3. At any of the study sites

4. 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

1. Participated in the intervention arm of Aim 2, or

2. Is a site principal investigator at one of the 4 participating study sites

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Mack, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Mack, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Emory University School of Medicine

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

U01CA243688-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-003

Identifier Type: -

Identifier Source: org_study_id