Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma (PRORECECA)
Metastatic Renal Cell Carcinoma, Kidney Cancer, Kidney Neoplasm
About this trial
This is an interventional supportive care trial for Metastatic Renal Cell Carcinoma focused on measuring Patient-reported outcomes, Electronic reporting of symptoms, Physical function
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- Department of Oncology, Herlev and Gentofte Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Patient-reported outcomes arm (experimental arm)
Standard of care
This arm will be assigned to intervention by weekly electronic reporting of symptoms and side effects in an app. A specifically developed alert-algorithm will in real-time guide the patient to adjust supportive care or contact the hospital. The reported symptoms are sent to the hospital to a healthcare professional - depending on the severity of the reported symptoms the healthcare professional can schedule a visit at the clinic. The patient will also receive a health-related quality of life questionnaire (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) including the Physical Function domain in the app each month. Patient satisfaction regarding the patient-reported outcomes will be measured with the validated Patient-Reported Experience Measurement questionnaire at termination of participation.
This arm will continue standard procedure regarding side effect registration and handling. The patients will receive a health-related quality of life questionnaire (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire, EORTC QOL-C30) at baseline, after 1, 3, and 6 months of participation in the study.