Clinical trial · Interventional
Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma
Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma; a Randomized Controlled Trial
NCT05135832CI-TRIAL-00055249PRORECECAunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Kidney Neoplasm | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Urologic Cancer | — | UNRESOLVED | — |
| Urologic Neoplasms | Urinary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electronic patient-reported outcomes regarding symptoms and health-related quality of life | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patient-reported outcomes arm (experimental arm)
- description
- 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.
- interventionNames
- Device: Electronic patient-reported outcomes regarding symptoms and health-related quality of life
- type
- NO_INTERVENTION
- label
- Standard of care
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with metastatic renal cell carcinoma 2. Age ≥ 18 years 3. Starting 1st or 2nd line treatment at enrolment 4. Performance status (PS) ≤ 2 5. Able to read Danish 6. No serious cognitive impairment 7. Patient has given written informed consent Exclusion Criteria: 1. No smart phone 2. 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. 3. Persons deprived of liberty or under guardianship or curators 4. 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 5. Earlier participation in PRORECECA (e.g. when changing from 1st to 2nd line of treatment)
References
Publications (0)
Data not yet available
No reference posted for this study.