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| ID | Type | Description | Link |
|---|---|---|---|
| P-2021-693 | Other Identifier | Videnscenter for Dataanmeldelser / PACTIUS |
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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-CTCAEâ„¢) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient-reported outcomes arm (experimental arm) | Experimental | 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. |
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| Standard of care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic patient-reported outcomes regarding symptoms and health-related quality of life | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Kirstine H Møller, MD, PhD | Contact | +4538683868 | anne.kirstine.hundahl.moeller@regionh.dk | |
| Jesper A Palshof, MD, PhD | Contact | +4538683868 | jesper.andreas.palshof@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Ida Marie L Rasmussen, MD | Herlev and Gentofte Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Herlev and Gentofte Hospital | Herlev | 2730 | Denmark |
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| 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 |
| 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 |
| Symptom management (number) | Registration of differences in number of intervention in the two treatment arms. | Within the first 6 months of treatment |
| Symptom management (type) | Registration of differences in types of intervention in the two treatment arms. | 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. | Within the first 6 months of treatment |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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