CLINICAL TRIAL / NCT04323774

Intervention For AYAS With Cancer Risk Syndromes

Interventional
Active
NCT04323774

Eligibility Details Visit Clinicaltrials.gov

Contact Information

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

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 Details

Gender
All

Age Group
12 Years to 24 Years

Accepting Healthy Volunteers
Accepts Healthy Volunteers

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