PRO-VISION: Patient Reported Outcomes-Based Monitoring of VEGF-Inhibitor Side Effects in ONcology
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Relative dose intensity
研究概览
简要总结
The purpose of this study is to investigate how collecting information about treatment-related side effects directly from patients can help manage the side effects associated with certain oral chemotherapies. This study is specifically investigating this approach in patients taking oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs) for metastatic renal cell carcinoma (mRCC).
Participants in this study will receive a survey via email or telephone once a week while receiving treatment with a VEGFR TKI. The survey will ask about symptoms such as nausea or fatigue and overall quality of life. This survey should take no more than 15 minutes to complete.
The survey will be sent directly to the oncology care team. Participants will receive a follow-up phone call or message from the team when participants have new or worsening symptoms. The participants will continue to receive surveys for as long as they are receiving a VEGF TKI treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Adult patients aged 18 years or older
- •Histologically confirmed renal cell carcinoma requiring treatment with VEGF TKI.
- •Patients may be receiving other concurrent cancer-directed therapy such as immune checkpoint inhibitors.
- •English or Spanish speaking
- •Ability to complete PRO surveys (i.e. ability to read/write or access to telephone or internet)
- •Willing and able to meet all study requirements
排除标准
- •All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
- •Inability for any reason to complete PRO surveys
研究组 & 干预措施
Patient Perspective
Study participants will complete several questionnaires/assessments related to adverse events and quality of life.
干预措施: Survey Questionnaire (Other)
结局指标
主要结局
Relative dose intensity
时间窗: Up to 3 years
Relative dose intensity is defined as the actual treatment dose taken per unit of time divided by the standard or initially prescribed dose per unit during the duration of treatment with VEGF TKI.
次要结局
- Duration of treatment on VEGF TKI regimen(Up to 3 years)
- Dose modifications(Up to 3 years)
- Health-related quality of life and symptom burden -Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events(Up to 3 years)
- Dose interruption(Up to 3 years)
- Hospital admissions(Up to 3 years)
- Emergency department visits(Up to 3 years)
- Duration of treatment on initial VEGF TKI dose(Up to 3 years)
- Treatment satisfaction(Up to 3 years)
- Progression-free survival(Up to 3 years)
- Adherence to Patient Reported Outcome -based symptom(Up to 3 years)
- Health-related quality of life and symptom burden - EuroQol-5 Dimension (EQ-5D-5L) questionnaire.(Up to 3 years)
- Health-related quality of life and symptom burden- Functional Assessment of Cancer Therapy Kidney System Index(Up to 3 years)
- VEGF TKI treatment adherence(Up to 3 years)