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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of the AYA-PARTNER Intervention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: AYA-PARTNER Navigation Intervention (Behavioral)
结局指标
主要结局
Feasibility of the AYA-PARTNER Intervention
时间窗: 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.
次要结局
- Participant Enrollment Rate(Up to 4 months)
- Acceptability of the AYA-PARTNER Intervention(Up to 4 months)
- Provider Acceptability of the AYA-PARTNER Intervention(Up to 4 months)