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NCT Number: NCT04323774

Intervention For AYAS 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Risk Syndrome

Age range

12 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University School of Medicine, Atlanta, Georgia, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Other names: AYA-RISE

Standard clinical visit for genetic counseling

Behavioral

Standard clinical visit for genetic counseling and follow up

Primary outcomes

  1. 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. Percentage of Acceptability

    Time frame: 2 years

    Acceptability (>70% AYAs consider the intervention acceptable, measured as a post-test AIM score >4.)

  3. 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.

  4. 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.

  5. Patient ownership of information in the intervention arm

    Time frame: 24 Months

    determined as % AYAs able to store and access portal information

  6. 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.

  7. Utilization of AYA-RISE

    Time frame: 2 Years

    Chat transcripts and patient portal access

  8. 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

  9. 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?

  10. 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?

  11. Fidelity of AYA-RISE

    Time frame: 2 Years

    • Site RA: Observation and Checklist
    • Does actual implementation match the planned process?

  12. 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?

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: AYA-RISE

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Mar 27, 2020
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.