ACTIVE_NOT_RECRUITING

Intervention For AYAS With Cancer Risk Syndromes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2021-03-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04323774

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.

Ages Eligible for Study:12 Years to 24 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Across all study aims, we will enroll AYA patients, family members/caregivers, and providers.
  2. 1. Ages 12-24 years, inclusive
  3. 2. Diagnosed with a cancer risk syndrome
  4. 3. English-speaking and -reading
  5. 4. Receiving care at any of the study sites OR participating in the LiFraumeni Syndrome Association (LFSA) Youth Conference
  6. 5. Adequate cognitive function per NeuroQOL indicated by a score of 30 or greater
  7. 6. Not receiving active cancer therapy
  8. 1. Parent/guardian, spouse/partner, or other family member who participates in the care of AYAs aged 12-24 with cancer risk syndromes
  9. 2. English-speaking and -reading
  10. 3. At any of the study sites
  11. 1. English-speaking and reading
  12. 2. Caring for AYAs aged 12-24 with cancer risk syndromes at any of the study sites
  13. 1. Ages 12-24 years, inclusive
  14. 2. Diagnosed with a cancer risk syndrome
  15. 3. English-speaking and -reading
  16. 4. Receiving care at Dana-Farber Cancer Institute
  17. 5. Adequate cognitive function per NeuroQOL, indicated by a score of 30 or greater
  18. 6. Not receiving active cancer therapy
  19. 7. Did not participate in a stakeholder interview
  20. * Family caregivers of participating 12-17y patients will be eligible to participate in the pilot
  21. * 12-17y patients can participate without a family member if both the patient and family member agree.
  22. * Patients 18-24y will have the option to participate with or without a family member.
  23. 1. Ages 12-24 years, inclusive
  24. 2. Diagnosed with a cancer risk syndrome
  25. 3. English-speaking and reading
  26. 4. Has a planned post-disclosure genetic counseling or follow-up visit at any of the study sites
  27. 5. Adequate cognitive function per NeuroQOL, indicated by a score of 30 or greater
  28. 6. Not receiving active cancer therapy
  29. 7. Did not participate in either part of Aim 1 (interview or pilot)
  30. 1. Parent/guardian, spouse/partner, or other family member who participates in the care of AYAs aged 12-24 with cancer risk syndromes
  31. 2. English-speaking and -reading
  32. 3. At any of the study sites
  33. 4. Did not participate in either part of Aim 1 (interview or pilot)
  34. 1. Participated in the intervention arm of Aim 2, or
  35. 2. Is a site principal investigator at one of the 4 participating study sites
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Jennifer Mack, MD
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute

Study Locations (Sites)

Emory University School of Medicine
Atlanta, Georgia, 30342
United States
University of Chicago
Chicago, Illinois, 60637
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • Jennifer Mack, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2021-03-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-03-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Cancer Risk Syndrome
  • LiFraumeni Syndrome Association (LFSA) Youth Conference

Additional Relevant MeSH Terms

  • Cancer Risk Syndrome