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| ID | Type | Description | Link |
|---|---|---|---|
| s52586 | Registry Identifier | Clinical Trial Center UZ Leuven |
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| Name | Class |
|---|---|
| Flemish League Against Cancer | OTHER |
| Pfizer | INDUSTRY |
| Novartis | INDUSTRY |
| GlaxoSmithKline |
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Prospective non-interventional non-controlled multicenter observational study to evaluate aspects of pharmaceutical care in patients with advanced renal cell carcinoma treated with an oral anti-cancer drug.
The main objective of this study is to evaluate the patient perspective in the treatment of advanced renal cell carcinoma with an oral anti-cancer drug.
The following aspects will be investigated:
This study should reveal information necessary for the development of pharmacotherapeutic care concepts that meet the needs of cancer patients treated with an oral anti-cancer drug over a long period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRCC patients | Patients with metastatic renal cell carcinoma |
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| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence | At the first visit patients will receive their anti-cancer medication by the hospital in a pill box which electronically records openings cf. Medication Event Monitoring System (MEMS®, Aardex). The recorded information in this chip will be read in the hospital pharmacy each time the patient gets new capsules. This information is strictly confidential and can only be consulted by the research team at the KULeuven. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of Information Desire (EID) | Extent of information desire will be assessed, using a standardised questionnaire, at the start of the treatment, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier). | one year |
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Inclusion Criteria:
Exclusion Criteria:
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mRCC patients starting with an oral anti-cancer treatment
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| Name | Affiliation | Role |
|---|---|---|
| Veerle Foulon, Professor | Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| INDUSTRY |
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| Patient Satisfaction with Cancer Treatment Education (Ps-CaTE) |
Satisfaction with cancer treatment information will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier). |
| one year |
| Morisky Medication Adherence Scale (MMAS) | Medication adherence will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier). | one year |
| Cancer Therapy Satisfaction Questionnaire (CTSQ) | Satisfaction with cancer treatment will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier). | one year |
| Functional Assessment of Cancer Therapy - General (FACT-G) | Health-related quality of life will be assessed, using a standardised questionnaire, at the start of the treatment, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier). | one year |
| Functional Kidney Symptom Index (FKSI) | Health-related quality of life will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier). | one year |
| Satisfaction With Pharmacist (SwiP) | Satisfaction with the pharmacist will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier). | one year |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic 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 |