Monitoring of Treatment Related Toxicities From Oral Targeted Agents and Immunotherapy Among Patients With Advanced Renal Cell Carcinoma (RCC) Using Carevive Software, a Single-Arm Phase II Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Reasons for Declining Study Participation
研究概览
简要总结
To determine if Carevive software, which monitors treatment-related toxicities and then generates self-care management plans for these symptoms, will be feasible to implement among patients with metastatic renal cell carcinoma (RCC). Additionally for collection of preliminary data on treatment-related toxicities, quality of life, distress level, and drug adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosis of histologically confirmed renal cell carcinoma of any subtype with either pathological or radiographic evidence of metastatic disease
- •Greater than 18 years of age
- •A participating Wilmot Cancer Center oncologist has determined that candidate should be started on either oral targeted therapy or immunotherapy for treatment of their advanced RCC; this can be for first-line or any subsequent line therapy
- •Able to provide written informed consent
- •Proficient in the English language and self-reports as literate
- •Must have an active email address or access to a smart device on which text messages can be received
排除标准
- •Women cannot be breast-feeding
- •Does not have regular access to the internet
- •Unable to come to the Wilmot Cancer Center for appointments every 3-4 months for routine visits with their primary oncologist
- •Subjects who were on the study previously will not be allowed to re-enroll in the event of a treatment change
研究组 & 干预措施
Use of Carevive software
Reporting and management of side effects from oral targeted therapy or immunotherapy, through Carevive software, in patients who have advanced Renal Cell Carcinoma (RCC).
干预措施: Carevive software (Other)
结局指标
主要结局
Reasons for Declining Study Participation
时间窗: 48 weeks
If a subject declines to participation in the study, he/she will be asked to provide a reason for declination. If willing, we will have them sign a separate consent with a space to write in their reason. The reason provided will be sorted into pre-specified categories and presented as a percentage.
Carevive Survey Usage Rates
时间窗: 48 weeks
Carevive software will track subject compliance with survey logins and whether they access the generated care plans. The percentage of times logged in out of the number of study recommended logins will be tabulated. Also, the percentage of times a careplan was accessed out of the number of times it was offered will be determined. * To determine the practicality of the intervention, by analyzing the reasons why subjects fail to self-report treatment-related toxicities or utilize software generated care plans after enrollment. * To assess the acceptability of this intervention with validated patient reported usability scores of the software. * To determine potential implementation obstacles of the intervention, by assessing the reasons eligible study candidates decline participation.
Average Usability Score Using the Software Usability Scoring System
时间窗: 48 weeks
At the 48 week time point or at the point of subject withdrawal from study, they will be asked to take the System Usability Scale. The survey provides us with a score of between 0 and 40 which is then multiplied by 2.5 to convert to a scale of 0 to 100. A SUS score above a 68 would be considered above average and anything below 68 is below average.
Reasons Participants Do Not Complete Survey or Utilize Care Plans
时间窗: 48 weeks
After missing a survey, subjects will be asked the reason at their following login. The reason provided will be sorted into pre-specified categories and presented as a percentage.
次要结局
- Clinician Reported Toxicities Using CTCAE(48 weeks)
- • Health Care Utilization Assessment By Quantification of Health Care Visits or Hospitalizations(48 weeks)
- Patient Reported Toxicities Using PRO-CTCAE Questions(48 weeks)
- Quality of Life Determination Using the FKSI-DRS Survey(48 weeks)
- Distress Level Using the NCCN Distress Thermometer(48 weeks)
研究者
Chunkit Fung
Doctor
University of Rochester