Status:
RECRUITING
Impact of the DROP Program on the DRP (Drug Related Problems) Related to Oral Anticancer Drugs in Ambulatory Patients with Risk Factors
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The rise of oral anticancer drugs favors outpatient care but exposes patients to new risks compared to injectable chemotherapy at hospital: non-adherence to treatment, inappropriate management of side...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT03257969
Start Date
June 18 2019
End Date
September 1 2026
Last Update
March 5 2025
Active Locations (1)
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1
Service pharmaceutique, Unité de Pharmacie Clinique Oncologique, Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69310