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临床试验/NCT07463547
NCT07463547Enrolling By Invitation不适用

Evaluating the Implementation and Impact of Navigator-Delivered ePRO Home Symptom Monitoring and Management - Wearable Integration in Symptom Evaluation for Cancer Survivors

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年4月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
20
试验地点
1
主要终点
Feasibility thresholds for uptake and compliance

研究概览

简要总结

The objective of this work is the production of actionable insights that can be leveraged to improve remote symptom monitoring (RSM) in varied practice settings, which in turn, is expected to improve timely, efficient, and high-quality comprehensive care in oncology. Aim 1: To assess the feasibility of incorporating a wearable into an RSM program for patients receiving cancer treatment. Aim 2: To assess the relationship between the wearable and ePRO-reported physical symptoms and functional status. Aim 3: To characterize barriers and facilitators of using the wearable in the RSM program and suggest approaches to incorporating relevant evidence-based interventions.

详细描述

Remote symptom monitoring (RSM) using electronic patient-reported outcomes (ePROs) benefits patients with cancer on active treatment (i.e., improved symptom assessment efficiency, patient-clinician communication and satisfaction, symptom control and well-being, overall survival). Despite promising RSM results, low sustained adherence and the limited amount of symptom information that can be feasibly captured through surveys limit RSM benefits. Passive data collection through wearable technology may strengthen RSM benefits by providing a more complete and continuous picture of patient health, without substantial patient and system burden. For this investigation, we leverage our existing RSM infrastructure to test the integration of a wearable for enhanced monitoring.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) ≥18 years of age; (2) diagnosed with cancer; (3) enrolled in the ePRO RSM program at O'Neal CCC; (4) uses a smart phone compatible with the wearable.

排除标准

  • (1) Lack of English fluency and literacy; (2) Medical condition that makes the person unable to participate, at PI discretion.

研究组 & 干预措施

Patient Group - Wearable

Experimental

Patients are given a wearable to use which tracks physiological health metrics (e.g., sleep, activity, heart rate variability)

干预措施: Wearable (Other)

结局指标

主要结局

Feasibility thresholds for uptake and compliance

时间窗: 6 months

% of eligible patients agree to wearable use and % adherence

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabrielle Rocque

Associate Professor of Medicine, Division of Hematology & Oncology; Division of Gerontology, Geriatrics, & Palliative Care

University of Alabama at Birmingham

研究点 (1)

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