Intervention For AYAS With Cancer Risk Syndromes (AYA-RISE)

Dana-Farber Cancer Institute

Status: Active, not recruiting

Conditions: Cancer Risk Syndrome

Treatments: Behavioral: AYA-RISE Adolescents and Young Adults Risk Information and Screening Education; Behavioral: Standard clinical visit for genetic counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04323774

20-003

U01CA243688-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 115 patients

Sex: All

Ages: 12 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 5 patient groups

Aim 1-Part 1 Stakeholder Interview

No Intervention group

Description:

This arm will focus 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

Experimental group

Description:

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

Treatment:

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

Aim 2-Genetic Counseling

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard clinical visit for genetic counseling

Aim 2- Genetic Counseling with AYA-RISE

Experimental group

Description:

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.

Treatment:

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

Aim 3 Semi-structured interviews

No Intervention group

Description:

Each site will conduct 30-minute interviews with patients, caregivers, and providers, and site principal investigators.