Impact of the DROP Program on the DRP (Drug Related Problems) Related to Oral Anticancer Drugs in Ambulatory Patients With Risk Factors

Study Overview
=================
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.

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

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: The DROP program of pharmaceutical interventions
* Behavioral: Standard of care


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The DROP program<br> | Behavioral: The DROP program of pharmaceutical interventions<br>* Multidisciplinary program that includes informative sessions with a hospital pharmacist about the oral anticancer drug: information is given to the patient on adverse events occurrence and there management; and optimizing drug dosage plan, including drug-drug interactions.<br>|
| Other: Standard of care<br> | Behavioral: Standard of care<br>* In the group with standard of care, patients will have interviews with a clinical research associate only dedicated to the record of data for outcomes assessment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of DRP (Drug Relates Problems) related to oral anticancer drugs per patient, in total and for each category | DRP are defined as the number of: adverse reactions (grade 2-3-4); drug interactions (contraindication, association not recommended, precautionary use); and medication errors with proven harm or requiring appropriate monitoring (Medication Error Index of the National Coordinating Council for Medication Error Reporting and Prevention, grade D to I). | 9 months post-inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of DRP related to all prescribed drugs per patient | DRP are defined as the number of: adverse reactions (grade 2-3-4); drug interactions (contraindication, association not recommended, precautionary use); and medication errors with proven harm or requiring appropriate monitoring (Medication Error Index of the National Coordinating Council for Medication Error Reporting and Prevention, grade D to I). | 6 months and 9 months post-inclusion | 
| Number of adaptations in the prescription of oral anticancer drugs, related to DRP, per patient | dose adjustments, cure spacing, interruptions and cessation of treatment. | 6 months and 9 months post-inclusion | 
| Relative dose intensity of the oral anticancer drug | Relative dose intensity will be computed by the ratio between the overall dose prescribed during the 6 months of follow-up and the theoretical dosage according to the summary of product characteristics of the market authorization. | 6 months post-inclusion | 
| Adherence to the oral anticancer drug | Adherence will be measured with the Girerd questionnaire score 6 items from the Ameli Health Insurance website and the rate of prescription renewal by the ambulatory pharmacy (adherence will be defined as a rate ≥80%). | 6 months post-inclusion | 
| Number of imaging acts and nature of acts | To evaluate consumption of unscheduled ambulatory care related to DRP | During the 6 months of follow-up | 
| Number of acts of biology and nature of acts | To evaluate consumption of unscheduled ambulatory care related to DRP | During the 6 months of follow-up | 
| Number of medical consultations | To evaluate consumption of unscheduled ambulatory care related to DRP | During the 6 months of follow-up | 
| Number of prescriptions of drugs (without prescription of the oral anticancer drug) and nature of these drugs | To evaluate consumption of unscheduled ambulatory care related to DRP | During the 6 months of follow-up | 
| Number of hospital admissions | To evaluate unplanned hospital admissions related to DRP | During the 6 months of follow-up | 
| Patient's quality of life, measured with the EuroQol 5-Dimensions questionnaire |  | At inclusion and 6 months from the treatment initiation | 
| Patient's satisfaction with treatment, measured with the SAT-MED Q questionnaire |  | At inclusion and 6 months from the treatment initiation | 
| Health locus of control, measured with the Therapeutic Self Care Toll (TSCT) scale |  | At inclusion and 6 months from the treatment initiation | 
| Number of interventions of primary care actors with the patient | To evaluate the involvement of primary care actors in the DROP program | During the 9 months of follow-up | 
| Number of time the Oncolien website was used by ambulatory care pharmacists | To evaluate the involvement of primary care actors in the DROP program | During the 9 months of follow-up | 
| Number of forms helping the delivery of the oral anticancer drug used by ambulatory care pharmacists | To evaluate the involvement of primary care actors in the DROP program | During the 9 months of follow-up | 
| Number of patient-advice forms downloaded and delivered to the patient | To evaluate the involvement of primary care actors in the DROP program | During the 9 months of follow-up | 
| Number and reason for solicitations of hospital actors by the primary care actors, in the context of information sharing | To evaluate the involvement of primary care actors in the DROP program | During the 9 months of follow-up | 
| Patient's satisfaction for the DROP program | Satisfaction will be measured with a 10-point visual analog scale. | At 9 months post-inclusion | 
| Ambulatory care physician's and pharmacist's satisfactions with the DROP program | Satisfaction will be measured with a 10-point visual analog scale. | At 9 months post-inclusion | 
| Efficiency of the DROP program | Efficiency will be computed by the incremental cost-efficacy ratio between the DROP program and the usual care. | 9 months post-inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral chemotherapy, Health related program, Secured drug intake, Pharmacist intervention, Cancer outpatient