Stage III Renal Cell Cancer Clinical Trial
Official title:
Safety and Compliance of Patients Treated With Oral Route Anti Cancer Drugs.
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.
Data obtained from patients via the questionnaires will be copied into a computer database
and as follows :
- 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.
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