- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04323774
Intervention For AYAS With Cancer Risk Syndromes (AYA-RISE)
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
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer Mack, MD
- Phone Number: (617) 632-6622
- Email: JMACK@PARTNERS.ORG
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30342
- Recruiting
- Emory University School of Medicine
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Contact:
- Christopher Porter, MD
- Email: chris.porter@emory.edu
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Illinois
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Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago
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Contact:
- Tara Henderson, MD
- Email: thenderson@peds.bsd.uchicago.edu
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Recruiting
- Boston Children's Hospital
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Contact:
- Jennifer Mack, MD
- Phone Number: 617-632-6622
- Email: JMACK@PARTNERS.ORG
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Principal Investigator:
- Jennifer Mack, MD
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Boston, Massachusetts, United States, 02115
- Recruiting
- Dana Farber Cancer Institute
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Contact:
- Jennifer Mack, MD
- Phone Number: 617-632-6622
- Email: JMACK@PARTNERS.ORG
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Principal Investigator:
- Jennifer Mack, MD
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Utah
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Salt Lake City, Utah, United States, 84112
- Recruiting
- University of Utah, Huntsman Cancer Institute
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Contact:
- Luke Maese, DO
- Email: luke.maese@hsc.utah.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
- Ages 12-24 years, inclusive
- Diagnosed with a cancer risk syndrome
- English-speaking and -reading
- 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
Study Plan
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:
|
|
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:
|
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:
|
Active Comparator: Aim 2-Genetic Counseling
The names of the study activities involved in this study are:
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:
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:
|
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)
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2 years
|
Percentage of Acceptability
Time Frame: 2 years
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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.
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baseline to post-visit surveys up to 24 months
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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.
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baseline to post-visit surveys up to 24 months
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Patient ownership of information in the intervention arm
Time Frame: 24 Months
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determined as % AYAs able to store and access portal information
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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.
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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
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2 Years
|
Acceptability of AYA-RISE
Time Frame: 2 Years
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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
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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
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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
|
2 Years
|
Fidelity of AYA-RISE
Time Frame: 2 Years
|
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer Mack, MD, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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