Advanced Renal Cell Carcinoma, Kidney Cancer, Kidney Neoplasm, Metastatic Renal Cell Carcinoma, Urologic Cancer, Urologic Neoplasms
Conditions
Keywords
Patient-reported outcomes, Electronic reporting of symptoms, Physical function
Brief 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.
Interventions
DEVICEElectronic 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.
Sponsors
Herlev and Gentofte Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical function | Within the first 3 months of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health related quality of life | Within the first 6 months of treatment | 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). |
| Admissions (number) | Within the first 6 months of treatment | 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. |
| Symptom management (type) | Within the first 6 months of treatment | Registration of differences in types of intervention in the two treatment arms. |
| Symptom management (number) | Within the first 6 months of treatment | Registration of differences in number of intervention in the two treatment arms. |
| Number of contacts to the clinic | Within the first 6 months of treatment | 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. |
| Admissions (length) | Within the first 6 months of treatment | 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. |
Countries
Denmark
Contacts
Primary ContactAnne Kirstine H Møller, MD, PhD
Backup ContactJesper A Palshof, MD, PhD
Outcome results
None listed