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

Cancer Clinical Trial

— DROP-SFPO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03257969
• Other study ID #: 69HCL17_0029
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2019
• Est. completion date: March 2023

Study information

• Verified date: October 2021
• Source: Hospices Civils de Lyon
• Contact: Catherine RIOUFOL, PharmD
• Phone: 04 78 86 43 70
• Email: catherine.rioufol[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• The DROP program of pharmaceutical interventions
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.
• Standard of care
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.

Locations

Country	Name	City	State
France	Service pharmaceutique, Unité de Pharmacie Clinique Oncologique, Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of medical consultations	To evaluate consumption of unscheduled ambulatory care related to DRP	During the 6 months of follow-up
Secondary	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
Secondary	Number of hospital admissions	To evaluate unplanned hospital admissions related to DRP	During the 6 months of follow-up
Secondary	Patient's quality of life, measured with the EuroQol 5-Dimensions questionnaire		At inclusion and 6 months from the treatment initiation
Secondary	Patient's satisfaction with treatment, measured with the SAT-MED Q questionnaire		At inclusion and 6 months from the treatment initiation
Secondary	Health locus of control, measured with the Therapeutic Self Care Toll (TSCT) scale		At inclusion and 6 months from the treatment initiation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient's satisfaction for the DROP program	Satisfaction will be measured with a 10-point visual analog scale.	At 9 months post-inclusion
Secondary	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
Secondary	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