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NCT04323774 | RECRUITING | Cancer Risk Syndrome

Intervention For AYAS With Cancer Risk Syndromes
Sponsor:

Dana-Farber Cancer Institute

Information provided by (Responsible Party):

Jennifer Mack, MD

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.

Condition or disease

Cancer Risk Syndrome

Intervention/treatment

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

Standard clinical visit for genetic counseling

Phase

NA

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
Estimated Enrollment : 354 participants
Masking : NONE
Primary Purpose : HEALTH_SERVICES_RESEARCH
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
Actual Study Start Date : 2021-03-01
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 12 Years to 24 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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
Intervention For AYAS With Cancer Risk Syndromes

Location Details

NCT04323774

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Georgia

Emory University School of Medicine

Atlanta, Georgia, United States, 30342

RECRUITING

United States, Illinois

University of Chicago

Chicago, Illinois, United States, 60637

RECRUITING

United States, Massachusetts

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02115

RECRUITING

United States, Utah

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112