Patient Reported Outcomes in Radiation Therapy (PRO-RT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Survey completion rate
研究概览
简要总结
This study explores the use of the Hugo platform to involve study participants in their healthcare and treatments. The Hugo platform may allow researchers to collect better and more accurate real-time health data, from other clinics/hospitals, pharmacies and other electronic devices. The purpose of this research is to see if the use of the Hugo platform is consistent, accurate, cost effective, and time efficient, as it collects and transmits important real-time health information from other clinics/hospitals, pharmacies, and other electronic devices.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the data aggregation from a patient centered platform over a follow up period for completeness and quality, including externally linked electronic health record (EHR) information, toxicity completion, and the patient reported outcomes (PRO) response rates for study patients, compared with historical pre-coronavirus disease (COVID) cohort of registry patients.
II. To explore biometric information obtained from wearables as it pertains to the toxicity of treatment for patients using a wearable device.
III. To estimate app-based survey completion rates using Hugo-based survey incentive completion (gift cards).
IV. To explore the cost data available on the platform.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •English speaking
- •Consented for Outcomes Registry Study (15-000136)
- •Undergoing radiotherapy for cancer treatment with curative intent
- •Willing to and able to give consent and participate in study
- •Willing to complete all surveys
- •Able to access a device (computer, smartphone, or tablet) with web access every day to complete study surveys
- •Willing to connect to a device (i.e., a smartphone, Fitbit, or tablet) that can regularly link to Hugo for data transfer
- •Willing to share personal information to Tremendous to be able to obtain the Visa e-cards for time and effort put into this study
- •Willing to use the Hugo health data sharing platform
- •Willing to create a Mayo Clinic Patient Portal (if not already created)
排除标准
- •Unable to give consent and enroll prior to administration of baseline survey
- •Partial breast radiation therapy (RT) (3 fraction), due to overlap in cadence used for all disease sites
- •Stereotactic body radiation therapy (SBRT) to the lung, due to overlap in cadence used for all disease sites
- •Co-enrollment on another PRO related study (soft rule)
- •Coordinator would need to get source data from Adam via Hugo
- •Response data will only be accessible by select people
结局指标
主要结局
Survey completion rate
时间窗: Baseline up to 6 months after completion of radiation therapy
The difference in rates will be estimated. A chi square, or Fisher's exact test as appropriate, will be used to compare the rates between cohorts. A logistic regression model will be used to understand the association of patient and disease variables with the odds of completion (at least one of the surveys at the treated site).
Percentage of patients with access to wearable device
时间窗: Up to 6 months after completion of radiation therapy
A logistic regression model will be used to understand the association of patient and disease variables with the odds of access to a wearable device.
次要结局
- Incidence of adverse events(Up to 6 months after completion of radiation therapy)