Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma; a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Physical function
研究概览
简要总结
The purpose of PRORECECA is to test whether adding weekly active patient-reported outcomes to the treatment of patients with metastatic renal cell carcinoma can improve patient-reported physical function.
详细描述
PRORECECA is a two-armed randomized controlled trial for patients with metastatic renal cell carcinoma initiating 1st or 2nd line of standard therapy.
Patients will be randomized to either receiving questions from Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) with a specifically developed alert-algorithm and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) or receiving standard procedure regarding side effect registration and handling.
The hypothesis is that weekly active patient-reported outcomes in the intervention group can improve physical function 30% compared to the group who receive standard care and standard handling of side effects.
A total of 174 patients will be included with 87 patients in each arm.
Primary endpoint is physical function reported by the patient after 3 months of treatment. The patients will assess their physical function by completing the EORTC QLQ-C30.
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
- •Patients with metastatic renal cell carcinoma
- •Age ≥ 18 years
- •Starting 1st or 2nd line treatment at enrolment
- •Performance status (PS) ≤ 2
- •Able to read Danish
- •No serious cognitive impairment
- •Patient has given written informed consent
排除标准
- •No smart phone
- •Patient participating in other interventional studies. This is only relevant for studies that might interfere with the intervention. Cases of doubt will be settled by the protocol committee.
- •Persons deprived of liberty or under guardianship or curators
- •Dementia, mental alteration or psychiatric disease that can compromise informed consent from the patient and / or adherence to the protocol and the monitoring of the trial
- •Earlier participation in PRORECECA (e.g. when changing from 1st to 2nd line of treatment)
结局指标
主要结局
Physical function
时间窗: Within the first 3 months of treatment
Patient-reported physical function in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) - Whether patients using PRO experience a better physical function compared to patients receiving standard care and handling of side effects.
次要结局
- Admissions (number)(Within the first 6 months of treatment)
- Admissions (length)(Within the first 6 months of treatment)
- Health related quality of life(Within the first 6 months of treatment)
- Number of contacts to the clinic(Within the first 6 months of treatment)
- Symptom management (number)(Within the first 6 months of treatment)
- Symptom management (type)(Within the first 6 months of treatment)
研究者
Ida Rasmussen
Principal investigator, MD
Herlev and Gentofte Hospital