Intervention For AYAS With Cancer Risk Syndromes
Purpose
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
- Cancer Risk Syndrome
Eligibility
- Eligible Ages
- Between 12 Years and 24 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
No Intervention Aim 1-Part 1 Stakeholder Interview |
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 |
|
|
Experimental Aim 1-Part 2 |
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 |
|
|
Active Comparator Aim 2-Genetic Counseling |
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. |
|
|
Experimental Aim 2- Genetic Counseling with AYA-RISE |
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. |
|
|
No Intervention Aim 3 Semi-structured interviews |
Each site will conduct 30-minute interviews with patients, caregivers, and providers, and site principal investigators. |
|
Recruiting Locations
Boston, Massachusetts 02115
Boston, Massachusetts 02115
More Details
- Status
- Recruiting
- Sponsor
- Dana-Farber Cancer Institute
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