PDAC-PATHWAYS: A Digital Informational and Supportive Care App for Patients Initiating Neoadjuvant Therapy for Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility: intervention completion rate
研究概览
简要总结
This study aims to refine and pilot test PDAC-PATHWAYS, a digital informational and supportive care app for patients who are initiating neoadjuvant therapy for pancreatic ductal adenocarcinoma (PDAC).
详细描述
There are two parts of this study. Study Part 1 is an open pilot study to refine PDAC-PATHWAYS prior to larger-scale testing in a randomized controlled trial (RCT) setting. Study Part 1 is purely descriptive, as the investigators will use the data to refine PDAC-PATHWAYS before proceeding to Study Part 2.
Study Part 2 is a pilot RCT to assess the feasibility and acceptability of conducting a randomized trial of PDAC-PATHWAYS versus usual care. Participants will complete a baseline survey and then be randomized to PDAC-PATHWAYS versus usual care. This record reflects the clinical trial component (Study Part 2), as feasibility and acceptability outcomes will be collected for this phase only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years
- •Within 8 weeks of a documented decision to pursue neoadjuvant therapy for newly diagnosed, non-metastatic PDAC
- •Able to comprehend and speak English
排除标准
- •Comorbid health condition that would interfere with study participation, as identified by the cancer care team
研究组 & 干预措施
PDAC-PATHWAYS
PDAC-PATHWAYS is an informational and supportive care app for patients initiating neoadjuvant therapy for PDAC.
干预措施: PDAC-PATHWAYS (Behavioral)
Usual care
Participants randomized to usual care will receive routine treatment with their oncology clinicians.
干预措施: Usual Care (Other)
结局指标
主要结局
Feasibility: intervention completion rate
时间窗: 10 weeks
≥50% completion of at least four app modules among those assigned to the intervention
Feasibility: Enrollment rate
时间窗: 10 weeks
≥50% enrollment among consecutive eligible patients
次要结局
- Acceptability(10 weeks)
研究者
Kelsey S. Lau-Min, MD
Principal Investigator
Massachusetts General Hospital