Kidney Cancer Clinical Trial
— PRORECECAOfficial title:
Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma; a Randomized Controlled Trial
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.
Status | Not yet recruiting |
Enrollment | 174 |
Est. completion date | December 1, 2022 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Oncology, Herlev and Gentofte Hospital | Herlev |
Lead Sponsor | Collaborator |
---|---|
Herlev and Gentofte Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Within the first 3 months of treatment | |
Secondary | 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). |
Within the first 6 months of treatment | |
Secondary | 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. | Within the first 6 months of treatment | |
Secondary | 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. | Within the first 6 months of treatment | |
Secondary | Symptom management (number) | Registration of differences in number of intervention in the two treatment arms. | Within the first 6 months of treatment | |
Secondary | Symptom management (type) | Registration of differences in types of intervention in the two treatment arms. | Within the first 6 months of treatment | |
Secondary | 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. | Within the first 6 months of treatment |
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