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

NCT03630692 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 158

Last updated 2018-10-15

No results posted yet for this study

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.

Conditions

  • Metastatic Renal Cancer
  • Stage III Renal Cell Cancer

Interventions

DRUG

observance of oral drug treatment

Completion of questionnaires at 4 times during patient's oral route drug treatment

Sponsors & Collaborators

  • University of Angers, GRANEM

    collaborator UNKNOWN

  • Fondation ARC

    collaborator OTHER

  • Institut Cancerologie de l'Ouest

    lead OTHER

Principal Investigators

  • Francoise GRUDE, Pharmacist · Institut de Cancérologie de l'Ouest

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-25
Primary Completion
2020-01-31
Completion
2020-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03630692 on ClinicalTrials.gov