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| Name | Class |
|---|---|
| Angers University | OTHER |
| Fondation ARC | OTHER |
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Generally, in the trials, an observant patient is described as correctly taking 90 to 100% of the prescribed doses. Here, the 80% compliance rate will be the cut-off between observant and non-observant patients.
The evaluation methodology is based primarily on a survey of patients with metastatic or locally advanced kidney cancer who have just began an oral treatment protocol. The constitution of this cohort will be made from newly treated patients included by oncologists. The survey consists of implementing a series of questionnaires with each patient of the sample throughout the course of oral cancer care.
This series of questionnaires will aim to identify:
Data obtained from patients via the questionnaires will be copied into a computer database and as follows :
In parallel with the questionnaires, the Clinical Research Associate (CRAs) of the Observatory will collect data from the medical file on site. The data collected on an electronic Case Report Form (e-CRF) are as follows:
The number of subjects needed is calculated from observant patients. Based on the existing literature on adherence to chemotherapy or targeted oral therapy, the observed compliance rate is approximately 80%. However, since this characteristic is the object of this study and therefore not known ex ante, in the calculations of the sample size, the value allowing to obtain the lowest margin of error on the rate of compliance, an estimated prevalence of 50% compliance is used. By setting the risk of the first species at 5%, a confidence level of 95%, it is then necessary to include 132 patients.
In addition, given the difficulty inherent in the questionnaires in collecting all the information, 20% of the data was estimated not to be evaluable. It will therefore be necessary to include 158 patients in the study to reach our goal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| observance of oral drug treatment | Study of observant or nonobservant patient behavior for their oral drug treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observance of oral drug treatment | Drug | Completion of questionnaires at 4 times during patient's oral route drug treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Study of observant or nonobservant patient behavior via patient questionnaire | Observance is first calculated via the use of the Morisky's score. The value of the score is between 0 and 4. The 0 corresponds to the absence of observance, the 4 to the perfect observance. This score is completed by a question about drug delay (which measures poor compliance). A subjective measure of compliance is also obtained from the patient's positioning of his compliance on a scale from 0 to 10. The value 0 corresponds to the fact that the person indicates that they do not comply at all with the treatment prescribed by the oncologist. Conversely, the value 10 corresponds to the exact respect of the treatment prescribed by the oncologist. These two indicators are measured at different periods of treatment (1 month, 4 months ; 7 months and 10 months) via a patient questionnaire. | 11 months |
| Measure | Description | Time Frame |
|---|---|---|
| Oral route Progression Free Survival evaluation (PFS) | PFS (duration between treatment start and progression date) will be evaluated via medical records analysis. | 11 months |
| Oral route Response rate analysis |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients treated for a metastatic renal cancer by an oral route drug (sunitinib, axitinib, sorafenib, pazopanib, everolimus et cabozantinib) in Bretagne and Pays de la Loire area
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francoise GRUDE, Pharmacist | Contact | 33241352868 | francoise.grude@ico.unicancer.fr | |
| Fanny MARHUENDA, phD | Contact | 33241352700 | fanny.marhuenda@ico.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Francoise GRUDE, Pharmacist | Institut de Cancérologie de l'Ouest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de l'Ouest | Recruiting | Angers | 49000 | France |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Response rate will be evaluated via medical records analysis.
| 11 months |
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability). | adverse event due to treatment | 11 months |
| CHU | Recruiting | Angers | 49933 | France |
|
| Clinique Pasteur Saint Esprit | Recruiting | Brest | 29000 | France |
|
| CHU Morvan | Recruiting | Brest | 29609 | France |
|
| CHD Vendée | Recruiting | La Roche-sur-Yon | 85925 | France |
|
| Centre Hospitalier | Recruiting | Le Mans | 72000 | France |
|
| Clinique Victor Hugo | Recruiting | Le Mans | 72000 | France |
|
| Centre Catherine de Sienne | Recruiting | Nantes | 44000 | France |
|
| CHIC Quimper | Recruiting | Quimper | 29107 | France |
|
| Centre Eugène Marquis | Recruiting | Rennes | 35042 | France |
|
| CHP | Recruiting | Saint-Grégoire | 35768 | France |
|
| Clinique Mutualiste de l'Estuaire | Recruiting | Saint-Nazaire | 44606 | France |
|
| Centre Hospitalier | Recruiting | St-Malo | 35403 | France |
|
| CHP Océane | Recruiting | Vannes | 56000 | France |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |