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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
174
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.
Department of Oncology, Herlev and Gentofte Hospital
Herlev, Denmark
Physical function
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.
Time frame: Within the first 3 months of treatment
Health related quality of life
Registration of differences in quality of life between the two arms in the study. The quality of life questionnaires EORTC QLQ-C30 (scale range 0-100, a higher score indicating better quality of life) will be used for as quality of life measurement. Differences between the two arms will be tested using t-test and analysis of covariance (ANCOVA).
Time frame: Within the first 6 months of treatment
Admissions (number)
Registration of number of admissions. The registration is made to investigate whether the use of PRO and thereby a closer contact to the clinic between visits can decrease the number of hospital admissions.
Time frame: Within the first 6 months of treatment
Admissions (length)
Registration of length of admissions. The registration is made to investigate whether the use of PRO and thereby a closer contact to the clinic between visits can decrease the length of hospital admissions.
Time frame: Within the first 6 months of treatment
Symptom management (number)
Registration of differences in number of intervention in the two treatment arms.
Time frame: Within the first 6 months of treatment
Symptom management (type)
Registration of differences in types of intervention in the two treatment arms.
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Time frame: Within the first 6 months of treatment
Number of contacts to the clinic
Registration of number of contacts to the clinic (both phone and attendance). The registration is made to investigate whether the use of PRO de- or increases the number of contacts to the clinic.
Time frame: Within the first 6 months of treatment