Safety and Compliance of Renal Cancer Patients Treated by Non-IV Drugs
NCT ID: NCT03630692
Last Updated: 2018-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
158 participants
OBSERVATIONAL
2016-03-25
2020-06-30
Brief Summary
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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:
* the gradient of compliance of the patient with his treatment,
* all the factors likely to influence positively or negatively the latter, whether medical, material or socio-economic,
* the evolution of patient compliance during their treatment course,
* a patient's quality of life index through the standardized quality of life survey form (EORTC - Quality of Life Questionnaire QLQ C30 version 3).
* These questionnaires will be supplemented by the medical record data (including information on tolerance and possible drug interactions). The representativeness of the patients surveyed will be established by comparing the statistical characteristics of the surveyed population with those of the aggregate anonymous global data obtained by the two Medical Department of the French Regional Health Insurance of the two regions. From the data compiled by this study, different econometric models of patient behavior will seek to establish, in particular, a relationship between the probability that a given patient will be either non or poorly observant and the various variables proved to be statistically significant.
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Detailed Description
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* The date of birth (day, month and year),
* Sex,
* The patient's opinion and attitude towards the current treatment: compliance, adverse effects, lifestyle restrictions, changes in professional activity, family activities, relationships, physical fitness, moral, concomitant treatments, expenses not refunded parallels related to the management of adverse effects,
* The family situation, the number of children,
* Degrees obtained and employment,
* Net monthly income.
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:
* Type of cancer, date of diagnosis and metastatic disease, possible surgery and radiotherapy,
* Description of the different treatment lines: number of cures, start and end date, response, toxicities,
* Status of the patient at the end of the study.
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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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observance of oral drug treatment
Study of observant or nonobservant patient behavior for their oral drug treatment
observance of oral drug treatment
Completion of questionnaires at 4 times during patient's oral route drug treatment
Interventions
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observance of oral drug treatment
Completion of questionnaires at 4 times during patient's oral route drug treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient with metastatic or locally advanced kidney cancer
* Patient initiating for the first time an oral route anticancer drug : Sutent® (sunitinib), Nexavar® (sorafenib), Afinitor® (everolimus), Votrient® (pazopanib) and Inlyta® (axitinib) and Cabometyx® (cabozantinib)
* Patient having signed an informed consent
* Patient treated outside interventional clinical trial
Exclusion Criteria
* Patient with non-extensive kidney cancer
* Patient treated by surgery, radiotherapy and intravenous chemotherapy exclusively
* Patient unable to undergo protocol monitoring
* Patient included in an interventional trial
* Patient refusing a survey at home or having hearing problems
* Other medical conditions that may interfere with the understanding of the informed consent document, with the assessment of tolerance and the response to questionnaires
* Patient with another condition deemed incompatible with the patient's inclusion into the protocol.
* Patient under guardianship or trusteeship, deprived of liberty, underage patient or pregnant woman
* Patient not affiliated with a social security system beneficiary of such a scheme
18 Years
ALL
No
Sponsors
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University of Angers, GRANEM
UNKNOWN
Fondation ARC
OTHER
Institut Cancerologie de l'Ouest
OTHER
Responsible Party
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Principal Investigators
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Francoise GRUDE, Pharmacist
Role: PRINCIPAL_INVESTIGATOR
Institut de Cancérologie de l'Ouest
Locations
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Institut de Cancérologie de l'Ouest
Angers, , France
CHU
Angers, , France
Clinique Pasteur Saint Esprit
Brest, , France
CHU Morvan
Brest, , France
CHD Vendée
La Roche-sur-Yon, , France
Centre Hospitalier
Le Mans, , France
Clinique Victor Hugo
Le Mans, , France
Centre Catherine de Sienne
Nantes, , France
CHIC Quimper
Quimper, , France
Centre Eugène Marquis
Rennes, , France
CHP
Saint-Grégoire, , France
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, , France
Centre Hospitalier
St-Malo, , France
CHP Océane
Vannes, , France
Countries
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Central Contacts
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Facility Contacts
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Abadie-Lacourtoisie Sophie, MD
Role: primary
Bigot Pierre, MD
Role: primary
Hasbini Ali, MD
Role: primary
Schlürmann Friedricke, MD
Role: primary
L'Haridon Tifenn, MD
Role: primary
Cojocarasu Oana, MD
Role: primary
Voog Eric, MD
Role: primary
El Kouri Claude, MD
Role: primary
Schlürmann Friedricke, MD
Role: primary
Laguerre Brigitte, MD
Role: primary
Artignan Xavier, MD
Role: primary
Deguiral Philippe, MD
Role: primary
Desclos herve, MD
Role: primary
Monpetit Erik, MD
Role: primary
Other Identifiers
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TOPTACOS
Identifier Type: -
Identifier Source: org_study_id
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