Trials / Unknown
UnknownNCT05135832
Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma
Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma; a Randomized Controlled Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 174 (estimated)
- Sponsor
- Herlev and Gentofte Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Metastatic Renal Cell Carcinoma
- Kidney Cancer
- Kidney Neoplasm
- Urologic Cancer
- Urologic Neoplasms
- Advanced Renal Cell Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Electronic patient-reported outcomes regarding symptoms and health-related quality of life | Weekly reporting of patient-reported outcomes for closer contact between patient and clinic between treatment cycles. The supportive care (including drugs) is similar in the two treatment arms except for the use of electronic patient-reported outcomes. |
Timeline
- Start date
- 2021-12-13
- Primary completion
- 2022-12-01
- Completion
- 2022-12-01
- First posted
- 2021-11-26
- Last updated
- 2021-11-26
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT05135832. Inclusion in this directory is not an endorsement.