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.

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

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

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Data can be shared no earlier than 1 year following the date of publication

DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu