Safety and Compliance of Renal Cancer Patients Treated by Non-IV Drugs — TOPTACOS  

Stage III Renal Cell Cancer Clinical Trial

Official title: Safety and Compliance of Patients Treated With Oral Route Anti Cancer Drugs.

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Metastatic Renal Cancer
• Stage III Renal Cell Cancer

• NCT number: NCT03630692
• Study type: Observational
• Source: Institut Cancerologie de l'Ouest
• Contact: Francoise GRUDE, Pharmacist
• Phone: 33241352868
• Email: francoise.grude@ico.unicancer.fr
• Status: Recruiting
• Start date: March 25, 2016
• Completion date: June 2020