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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 115
- 试验地点
- 6
- 主要终点
- Sustainability of AYA-Rise
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Across all study aims, we will enroll AYA patients, family members/caregivers, and providers.
- •AIM 1, PART 1 - STAKEHOLDER INTERVIEWS
- •AYA Patients
- •Ages 12-24 years, inclusive
- •Diagnosed with a cancer risk syndrome
- •English-speaking and -reading
- •Receiving care at any of the study sites OR participating in the LiFraumeni Syndrome Association (LFSA) Youth Conference
- •Adequate cognitive function per NeuroQOL indicated by a score of 30 or greater
- •Not receiving active cancer therapy
- •Family caregivers-Inclusion Criteria
- •Parent/guardian, spouse/partner, or other family member who participates in the care of AYAs aged 12-24 with cancer risk syndromes
- •English-speaking and -reading
- •At any of the study sites
- •Providers Inclusion Criteria (Oncologists, nurses, genetic counselors, social workers, or psychologists)
- •English-speaking and reading
- •Caring for AYAs aged 12-24 with cancer risk syndromes at any of the study sites
- •AIM 1, PART 2 - INTERVENTION PILOT
- •AYA Patients
- •Ages 12-24 years, inclusive
- •Diagnosed with a cancer risk syndrome
- •English-speaking and -reading
- •Receiving care at Dana-Farber Cancer Institute
- •Adequate cognitive function per NeuroQOL, indicated by a score of 30 or greater
- •Not receiving active cancer therapy
- •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
- •Ages 12-24 years, inclusive
- •Diagnosed with a cancer risk syndrome
- •English-speaking and reading
- •Has a planned post-disclosure genetic counseling or follow-up visit at any of the study sites
- •Adequate cognitive function per NeuroQOL, indicated by a score of 30 or greater
- •Not receiving active cancer therapy
- •Did not participate in either part of Aim 1 (interview or pilot)
- •Family caregivers
- •Parent/guardian, spouse/partner, or other family member who participates in the care of AYAs aged 12-24 with cancer risk syndromes
- •English-speaking and -reading
- •At any of the study sites
- •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
- •Participated in the intervention arm of Aim 2, or
- •Is a site principal investigator at one of the 4 participating study sites
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: AYA-RISE Adolescents and Young Adults Risk Information and Screening Education (Behavioral)
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.
干预措施: Standard clinical visit for genetic counseling (Behavioral)
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.
干预措施: AYA-RISE Adolescents and Young Adults Risk Information and Screening Education (Behavioral)
Aim 3 Semi-structured interviews
Each site will conduct 30-minute interviews with patients, caregivers, and providers, and site principal investigators.
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
结局指标
主要结局
Sustainability of AYA-Rise
时间窗: 2 Years
An analytic matrix on intervention design will be used to code of semi-structured interviews Can the processes required for AYA-RISE be maintained beyond the research setting?
Change in psychological distress
时间窗: baseline to post-visit surveys up to 24 months
This change will be measured by baseline and post-visit survey responses using the psychosocial aspects of hereditary cancer (PAHC) measure.
Patient ownership of information in the intervention arm
时间窗: 24 Months
determined as % AYAs able to store and access portal information
Participants who followed up for recommended care
时间窗: screening and follow-up over the next year up to 24 Months
We will identify recommended care and screening via medical record review, and whether care was received, post-visit.
Utilization of AYA-RISE
时间窗: 2 Years
Chat transcripts and patient portal access
Acceptability of AYA-RISE
时间窗: 2 Years
Semi-structured interview: How did patients, providers, family members feel about the intervention? Was the experience positive, negative, or neutral? An analytic matrix on intervention design will be used to code of semi-structured interviews
Adoption of AYA-RISE
时间窗: 2 Years
An analytic matrix on intervention design will be used to code of semi-structured interviews \- Semi-structured interview of Providers and Clinic Leaders * Were patients and providers willing to try the intervention? * Would they want to continue to use the intervention?
Practicality of Using AYA-RISE
时间窗: 2 Years
An analytic matrix on intervention design will be used to code of semi-structured interviews: Site PI Semi-structured interview * Is it practical to continue to use AYA-RISE within constraints of * clinic, provider, and patient/family needs?
Percentage of Consenting AYA use AYA-RISE
时间窗: 2 years
The feasibility (\>70% consenting AYAs use AYA-RISE through the risk communication step of the chat and patient portal, based on use data from Clear Genetics)
Percentage of Acceptability
时间窗: 2 years
Acceptability (\>70% AYAs consider the intervention acceptable, measured as a post-test AIM score \>4.)
Change in patient knowledge of cancer risk and screening
时间窗: baseline to post-visit surveys up to 24 months
This change will be measured by baseline and post-visit survey responses on the Knowledge of Cancer Screening and Gist Comprehension of Genetic Cancer Risk measures.
Fidelity of AYA-RISE
时间窗: 2 Years
* Site RA: Observation and Checklist * Does actual implementation match the planned process?
Utilization of AYA-RISE
时间窗: 2 Years
Chat transcripts and patient portal access
Participants who followed up for recommended care
时间窗: screening and follow-up over the next year up to 24 Months
We will identify recommended care and screening via medical record review, and whether care was received, post-visit.
Percentage of Consenting AYA use AYA-RISE
时间窗: 2 years
The feasibility (\>70% consenting AYAs use AYA-RISE through the risk communication step of the chat and patient portal, based on use data from Clear Genetics)
Percentage of Acceptability
时间窗: 2 years
Acceptability (\>70% AYAs consider the intervention acceptable, measured as a post-test AIM score \>4.)
Change in patient knowledge of cancer risk and screening
时间窗: baseline to post-visit surveys up to 24 months
This change will be measured by baseline and post-visit survey responses on the Knowledge of Cancer Screening and Gist Comprehension of Genetic Cancer Risk measures.
Change in psychological distress
时间窗: baseline to post-visit surveys up to 24 months
This change will be measured by baseline and post-visit survey responses using the psychosocial aspects of hereditary cancer (PAHC) measure.
Patient ownership of information in the intervention arm
时间窗: 24 Months
determined as % AYAs able to store and access portal information
Acceptability of AYA-RISE
时间窗: 2 Years
Semi-structured interview: How did patients, providers, family members feel about the intervention? Was the experience positive, negative, or neutral? An analytic matrix on intervention design will be used to code of semi-structured interviews
Adoption of AYA-RISE
时间窗: 2 Years
An analytic matrix on intervention design will be used to code of semi-structured interviews \- Semi-structured interview of Providers and Clinic Leaders * Were patients and providers willing to try the intervention? * Would they want to continue to use the intervention?
Practicality of Using AYA-RISE
时间窗: 2 Years
An analytic matrix on intervention design will be used to code of semi-structured interviews: Site PI Semi-structured interview * Is it practical to continue to use AYA-RISE within constraints of * clinic, provider, and patient/family needs?
Fidelity of AYA-RISE
时间窗: 2 Years
* Site RA: Observation and Checklist * Does actual implementation match the planned process?
Sustainability of AYA-Rise
时间窗: 2 Years
An analytic matrix on intervention design will be used to code of semi-structured interviews Can the processes required for AYA-RISE be maintained beyond the research setting?
次要结局
未报告次要终点
研究者
Jennifer Mack, MD
Principal Investigator
Dana-Farber Cancer Institute