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

Sponsor

Institut Cancerologie de l'Ouest (Other)

Overall Status

Unknown status

CT.gov ID

NCT03630692

Collaborator

University of Angers, GRANEM (Other), Fondation ARC (Other)

158

Enrollment

Locations

50.2

Anticipated Duration (Months)

11.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Renal Cancer Stage III Renal Cell Cancer	Drug: observance of oral drug treatment

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

158 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 25, 2016

Anticipated Primary Completion Date :

Jan 1, 2020

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
observance of oral drug treatment Study of observant or nonobservant patient behavior for their oral drug treatment	Drug: observance of oral drug treatment Completion of questionnaires at 4 times during patient's oral route drug treatment Other Names: oral drug treatment

Arm

Intervention/Treatment

observance of oral drug treatment

Study of observant or nonobservant patient behavior for their oral drug treatment

Drug: observance of oral drug treatment

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

Other Names:

oral drug treatment

Outcome Measures

Primary Outcome Measures

Study of observant or nonobservant patient behavior via patient questionnaire [11 months]
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.

Secondary Outcome Measures

Oral route Progression Free Survival evaluation (PFS) [11 months]
PFS (duration between treatment start and progression date) will be evaluated via medical records analysis.
Oral route Response rate analysis [11 months]
Response rate will be evaluated via medical records analysis.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability). [11 months]
adverse event due to treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Institut de Cancérologie de l'Ouest	Angers	France	49000
2	CHU	Angers	France	49933
3	Clinique Pasteur Saint Esprit	Brest	France	29000
4	CHU Morvan	Brest	France	29609
5	CHD Vendée	La Roche-sur-Yon	France	85925
6	Centre Hospitalier	Le Mans	France	72000
7	Clinique Victor Hugo	Le mans	France	72000
8	Centre Catherine de Sienne	Nantes	France	44000
9	CHIC Quimper	Quimper	France	29107
10	Centre Eugène Marquis	Rennes	France	35042
11	CHP	Saint Grégoire	France	35768
12	Centre Hospitalier	Saint-Malo	France	35403
13	Clinique Mutualiste de l'Estuaire	Saint-Nazaire	France	44606
14	CHP Océane	Vannes	France	56000