Clinical trial NCT03257969: Impact of the DROP Program on the DRP (Drug Related Problems) Related to Oral Anticancer Drugs in Ambulatory Patients with Risk Factors
Official title: Impact of the DROP (Drug Related Problems in Oncology Practice) Program of Pharmaceutical Interventions of the French Society of Oncological Pharmacology Versus Usual Care on the DRP (Drug Related Problems) Related to Oral Anticancer Drugs in Ambulatory Patients with Risk Factors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Oral chemotherapy
Health related program
Secured drug intake
Pharmacist intervention
Cancer outpatient
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 effects and interactions with other co-prescribed drugs. Latrogenic risk of these treatments is reinforced in older patients with frequent comorbidities, taking multiple pharmaceutical treatments for long periods and followed by several prescribers.

The literature reports an emergence of drug related problems (DRP) in more than 90% of patients, with an average number of 0 to 4 per patient. The clinical consequences (reduced efficacy and potentiation of toxicity) are all the more important that outpatient monitoring of treatments prescribed at the hospital remains underdeveloped due to default of coordination between these two settings.

Medical care and prevention of these DRP are difficult because of a lack of information and tools shared between hospital and liberal actors. Experiments are developed according to different organizational models, frequently focused on the pharmaceutical analysis of prescriptions, the detection of DRP and their control, but they stay still undervalued. In this context, the French Society of Oncological Pharmacology (SFPO - Société Française de Pharmacie Oncologique) provides to hospital and ambulatory care pharmacists the Oncolien website and proposes to assess the impact of a program of pharmaceutical interventions named DROP. The hypothesis of the study is that the DROP program will secure the medical care of patients with oral anticancer drugs compared to the usual care.


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.

Primary outcomes:
measure: Number of DRP (Drug Relates Problems) related to oral anticancer drugs per patient, in total and for each category
timeFrame: 9 months post-inclusion
Secondary outcomes:
measure: Total number of DRP related to all prescribed drugs per patient
timeFrame: 6 months and 9 months post-inclusion
measure: Number of adaptations in the prescription of oral anticancer drugs, related to DRP, per patient
timeFrame: 6 months and 9 months post-inclusion
measure: Relative dose intensity of the oral anticancer drug
timeFrame: 6 months post-inclusion
measure: Adherence to the oral anticancer drug
timeFrame: 6 months post-inclusion
measure: Number of imaging acts and nature of acts
timeFrame: During the 6 months of follow-up
measure: Number of acts of biology and nature of acts
timeFrame: During the 6 months of follow-up
measure: Number of medical consultations
timeFrame: During the 6 months of follow-up
measure: Number of prescriptions of drugs (without prescription of the oral anticancer drug) and nature of these drugs
timeFrame: During the 6 months of follow-up
measure: Number of hospital admissions
timeFrame: During the 6 months of follow-up
measure: Patient's quality of life, measured with the EuroQol 5-Dimensions questionnaire
timeFrame: At inclusion and 6 months from the treatment initiation
measure: Patient's satisfaction with treatment, measured with the SAT-MED Q questionnaire
timeFrame: At inclusion and 6 months from the treatment initiation
measure: Health locus of control, measured with the Therapeutic Self Care Toll (TSCT) scale
timeFrame: At inclusion and 6 months from the treatment initiation
measure: Number of interventions of primary care actors with the patient
timeFrame: During the 9 months of follow-up
measure: Number of time the Oncolien website was used by ambulatory care pharmacists
timeFrame: During the 9 months of follow-up
measure: Number of forms helping the delivery of the oral anticancer drug used by ambulatory care pharmacists
timeFrame: During the 9 months of follow-up
measure: Number of patient-advice forms downloaded and delivered to the patient
timeFrame: During the 9 months of follow-up
measure: Number and reason for solicitations of hospital actors by the primary care actors, in the context of information sharing
timeFrame: During the 9 months of follow-up
measure: Patient's satisfaction for the DROP program
timeFrame: At 9 months post-inclusion
measure: Ambulatory care physician's and pharmacist's satisfactions with the DROP program
timeFrame: At 9 months post-inclusion
measure: Efficiency of the DROP program
timeFrame: 9 months post-inclusion
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service pharmaceutique, Unité de Pharmacie Clinique Oncologique, Centre Hospitalier Lyon Sud
Study officials:
References: