Safety and Compliance of Renal Cancer Patients Treated by Non-IV Drugs
TOPTACOS
Safety and Compliance of Patients Treated With Oral Route Anti Cancer Drugs.
1 other identifier
observational
158
1 country
14
Brief Summary
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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2016
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 25, 2016
CompletedFirst Submitted
Initial submission to the registry
August 6, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedOctober 15, 2018
August 1, 2018
3.8 years
August 6, 2018
October 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Oral route Progression Free Survival evaluation (PFS)
11 months
Oral route Response rate analysis
11 months
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).
11 months
Study Arms (1)
observance of oral drug treatment
Study of observant or nonobservant patient behavior for their oral drug treatment
Interventions
Completion of questionnaires at 4 times during patient's oral route drug treatment
Eligibility Criteria
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
You may qualify if:
- Adult patient
- 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
You may not qualify if:
- Patient with cancer other than kidney cancer
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Cancerologie de l'Ouestlead
- University of Angers, GRANEMcollaborator
- Fondation ARCcollaborator
Study Sites (14)
Institut de Cancérologie de l'Ouest
Angers, 49000, France
CHU
Angers, 49933, France
Clinique Pasteur Saint Esprit
Brest, 29000, France
CHU Morvan
Brest, 29609, France
CHD Vendée
La Roche-sur-Yon, 85925, France
Centre Hospitalier
Le Mans, 72000, France
Clinique Victor Hugo
Le Mans, 72000, France
Centre Catherine de Sienne
Nantes, 44000, France
CHIC Quimper
Quimper, 29107, France
Centre Eugène Marquis
Rennes, 35042, France
CHP
Saint-Grégoire, 35768, France
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, 44606, France
Centre Hospitalier
St-Malo, 35403, France
CHP Océane
Vannes, 56000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francoise GRUDE, Pharmacist
Institut de Cancérologie de l'Ouest
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2018
First Posted
August 15, 2018
Study Start
March 25, 2016
Primary Completion
January 1, 2020
Study Completion
June 1, 2020
Last Updated
October 15, 2018
Record last verified: 2018-08