Clinical trial NCT04323774: Intervention For AYAS With Cancer Risk Syndromes
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Risk Syndrome
Keywords: Cancer Risk Syndrome
LiFraumeni Syndrome Association (LFSA) Youth Conference
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-03-27
Enrollment: 354
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility 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

Primary outcomes:
measure: Percentage of Consenting AYA use AYA-RISE
timeFrame: 2 years
measure: Percentage of Acceptability
timeFrame: 2 years
measure: Change in patient knowledge of cancer risk and screening
timeFrame: baseline to post-visit surveys up to 24 months
measure: Change in psychological distress
timeFrame: baseline to post-visit surveys up to 24 months
measure: Patient ownership of information in the intervention arm
timeFrame: 24 Months
measure: Participants who followed up for recommended care
timeFrame: screening and follow-up over the next year up to 24 Months
measure: Utilization of AYA-RISE
timeFrame: 2 Years
measure: Acceptability of AYA-RISE
timeFrame: 2 Years
measure: Adoption of AYA-RISE
timeFrame: 2 Years
measure: Practicality of Using AYA-RISE
timeFrame: 2 Years
measure: Fidelity of AYA-RISE
timeFrame: 2 Years
measure: Sustainability of AYA-Rise
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Salt Lake City
country: United States
facility: University of Utah, Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Jennifer Mack, MD
role: PRINCIPAL_INVESTIGATOR
References: