Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT03257969
Eligibility Criteria:
Inclusion Criteria:
* Patient aged 18 years old or more
* With cancer
* For wich the initiation or change of an oral anticancer drug is prescribed
* With life expectancy estimated to be 6 months or more, in the opinion of the investigator
* Of which the treatment with oral anticancer medication is estimated to be 6 months or more in the opinion of the oncologist
* Benefiting from an initiation or a change of oral anticancer agents according to the MA: cytotoxic agent, targeted therapy, hormonal therapy (excluding adjuvant treatments);
* of which the oral anticancer drug is delivered in pharmacy of town or in retrocession hospital;
* With ambulatory status (not hospitalized for the management and treatment )
* Taking 5 or more drugs, including the oral anticancer treatment, and / or treated with an oral anticancer drug requiring complex regimen (combination of 2 oral anticancer drugs, or sequential rate of intake, or associated to intravenous chemotherapy)
* With a sufficient autonomy for the management of medication at home
* Without either cognitive disorders or major psychiatric disorders, in the opinion of the investigator
* Ability to read, write and understand the French language
* Having given his written consent to participate in the study
* Patient affiliated to the social security scheme or equivalent
Exclusion Criteria:
* Pregnant or lactating woman
* Patient on anti-PD1, anti-PDL-1 or anti-CTLA4-4 immunotherapy concomitant with oral anticancer treatment
* Patient under radiotherapy concomitant treatment with oral anticancer
* Oral anticancer agent prescribed in a delivery circuit as part of an ATU or clinical trial;
* Patient with significant cognitive or psychiatric disorders, in the opinion of the investigator;
* Management of drug treatment at home is performed exclusively by the caregiver;
* Not having declared a doctor;
* Not having a usual city pharmacy, or reporting 2 or more usual city pharmacies;
* Patient who has already benefited from a therapeutic education program
* In institution or guardianship, major protected by the Law.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03257969
Study Brief:
Protocol Section:
NCT03257969