Intervention For AYAS With Cancer Risk Syndromes (AYA-RISE)

May 9, 2023 updated by: Jennifer Mack, MD, Dana-Farber Cancer Institute

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

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

354

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory University School of Medicine
        • Contact:
    • Illinois
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital
        • Contact:
        • Principal Investigator:
          • Jennifer Mack, MD
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Dana Farber Cancer Institute
        • Contact:
        • Principal Investigator:
          • Jennifer Mack, MD
    • Utah
      • Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

Family caregivers-Inclusion Criteria

  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

Providers Inclusion Criteria (Oncologists, nurses, genetic counselors, social workers, or psychologists)

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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
Experimental: 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
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.
Other Names:
  • AYA-RISE
Active Comparator: 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.

Standard clinical visit for genetic counseling and follow up
Experimental: 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.

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.
Other Names:
  • AYA-RISE
No Intervention: Aim 3 Semi-structured interviews
Each site will conduct 30-minute interviews with patients, caregivers, and providers, and site principal investigators.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 years
Percentage of Acceptability
Time Frame: 2 years
Acceptability (>70% AYAs consider the intervention acceptable, measured as a post-test AIM score >4.)
2 years
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.
baseline to post-visit surveys up to 24 months
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.
baseline to post-visit surveys up to 24 months
Patient ownership of information in the intervention arm
Time Frame: 24 Months
determined as % AYAs able to store and access portal information
24 Months
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.
screening and follow-up over the next year up to 24 Months
Utilization of AYA-RISE
Time Frame: 2 Years
Chat transcripts and patient portal access
2 Years
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
2 Years
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?
2 Years
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?
2 Years
Fidelity of AYA-RISE
Time Frame: 2 Years
  • Site RA: Observation and Checklist
  • Does actual implementation match the planned process?
2 Years
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?
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jennifer Mack, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

March 23, 2020

First Submitted That Met QC Criteria

March 24, 2020

First Posted (Actual)

March 27, 2020

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-003
  • U01CA243688-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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