Feasibility Pilot of AYA-PARTNER (AYA-PARTNER)
Feasibility Pilot of the Adapted Adolescent and Young Adult Patient Advocacy, Real-Time Navigation, Equity and Reach (AYA-PARTNER) Intervention To Address Unmet Needs of AYAs Undergoing Active Cancer Treatment
This is a single-center, non-randomized feasibility pilot study of an adapted Adolescent and Young Adult Patient Advocacy, Real-Time Navigation, Equity and Reach (AYA-PARTNER) intervention for young adults ages 18-39 receiving systemic cancer treatment at the University of North Carolina at Chapel Hill (UNC) and UNC Rex and affiliated clinics.
The study will use information from the electronic health record to identify young adults who may have unmet needs during cancer treatment. Examples include emergency or urgent care visits, missed appointments, no activation of the patient portal (MyChart), or treatment plans that may cause significant side effects. A trained study navigator will confirm eligibility, obtain informed consent, and provide personalized support for 4 months. The navigator will contact participants at least once each month by phone, text message, email, MyChart, or video, based on participant preference. Support may include connecting participants with supportive care services and sharing concerns with their oncology care team.
The study will enroll 30 participants over 12 months, with a total study duration of 24 months. Participants will complete a needs assessment at the start of the study and again at 4 months, as well as a survey about their experience with the intervention at 4 months.
The main goal of the study is to determine whether the intervention is feasible, measured by the percentage of participants who complete the 4-month survey. The study will consider the intervention feasible if at least 50% of participants complete the survey. Other goals are to determine how many eligible patients agree to participate and how acceptable the intervention is to patients and oncology clinicians. The study will also explore changes in participants' unmet needs and describe how the navigation program is delivered, including navigator activities, participant engagement, and other factors that may affect implementation.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Hannah C Winslow
- 电话号码:919-984-0000
- 邮箱:Hannah_Winslow@med.unc.edu
研究联系人备份
- 姓名:Allison Bell
- 邮箱:allison_bell@med.unc.edu
学习地点
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North Carolina
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Chapel Hill、North Carolina、美国、27599
- University of North Carolina at Chapel Hill
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接触:
- Hannah C Winslow
- 电话号码:919-984-0000
- 邮箱:Hannah_Winslow@med.unc.edu
-
首席研究员:
- Jake Stein, MD
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-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
- Age 18-39 years at the time of consent.
- Histological or cytological evidence/confirmation of any invasive cancer.
- Currently receiving any form of systemic anti-cancer therapy
Exclusion Criteria:
- Patients only receiving surgery or radiation therapy (not systemic therapy)
- Unable to communicate in English.
- Patients do not have access to both phone and internet.
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:AYA-PARTNER
Young adults between 18 and 39 years of age who are currently receiving systemic anti-cancer therapy or are expected to begin systemic anti-cancer therapy within a month.
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Participants will receive personalized support and navigation from a trained study navigator for 4 months, with contact at least once each month through phone, text message, email, MyChart, or video based on their preference.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility of the AYA-PARTNER Intervention
大体时间:Up to 4 months
|
The proportion of patients who consent to participate and maintain contact through the 4-month intervention by completing the 4-month survey.
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Up to 4 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Participant Enrollment Rate
大体时间:Up to 4 months
|
The proportion of eligible patients who consent to participate in the intervention after eligibility is confirmed.
|
Up to 4 months
|
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Acceptability of the AYA-PARTNER Intervention
大体时间:Up to 4 months
|
Acceptability of the intervention will be measured at month 4 using an adapted 8-item Theoretical Framework of Acceptability (TFA) survey. Items are rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater acceptability. |
Up to 4 months
|
|
Provider Acceptability of the AYA-PARTNER Intervention
大体时间:Up to 4 months
|
Acceptability of the AYA-PARTNER intervention among oncology providers will be assessed at the end of the study using a provider version of the adapted 8-item Theoretical Framework of Acceptability (TFA) survey.
The survey will assess providers' perceptions of the intervention, including its appropriateness, ease of use, burden, and fit within routine clinical care.
Items will be rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater acceptability.
|
Up to 4 months
|
合作者和调查者
调查人员
- 首席研究员:Jacob Stein, MD、UNC Lineberger Comprehensive Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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