Intervention For AYAS With Cancer Risk Syndromes

Not Applicable

Recruiting

• Conditions: Cancer Risk Syndrome
• Interventions: Behavioral: AYA-RISE Adolescents and Young Adults Risk Information and Screening Education; Behavioral: Standard clinical visit for genetic counseling

• Registration Number: NCT04323774
• Lead Sponsor: Dana-Farber Cancer Institute

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

Study Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-27
• Study Start: 2021-03-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 354

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aim 2- Genetic Counseling with AYA-RISE	AYA-RISE Adolescents and Young Adults Risk Information and Screening Education	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.
Aim 2-Genetic Counseling	Standard clinical visit for 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.
Aim 1-Part 2	AYA-RISE Adolescents and Young Adults Risk Information and Screening Education	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

Primary Outcome Measures

Name	Time	Method
Percentage of Acceptability	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	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.
Utilization of AYA-RISE	2 Years	Chat transcripts and patient portal access
Adoption of AYA-RISE	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?
Fidelity of AYA-RISE	2 Years	* Site RA: Observation and Checklist; * Does actual implementation match the planned process?
Percentage of Consenting AYA use AYA-RISE	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)
Change in psychological distress	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	24 Months	determined as % AYAs able to store and access portal information
Participants who followed up for recommended care	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.
Acceptability of AYA-RISE	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
Sustainability of AYA-Rise	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?
Practicality of Using AYA-RISE	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?

Trial Locations

Locations (5)

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

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States