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

March 3, 2025 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
248

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Pierre-Bénite, France, 69310
        • Recruiting
        • Service pharmaceutique, Unité de Pharmacie Clinique Oncologique, Centre Hospitalier Lyon Sud
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Standard of care
Behavioral: 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.
Experimental: The DROP program
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 9 months post-inclusion
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total number of DRP related to all prescribed drugs per patient
Time Frame: 6 months and 9 months post-inclusion
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
Time Frame: 6 months and 9 months post-inclusion
dose adjustments, cure spacing, interruptions and cessation of treatment.
6 months and 9 months post-inclusion
Relative dose intensity of the oral anticancer drug
Time Frame: 6 months post-inclusion
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
Time Frame: 6 months post-inclusion
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
Time Frame: During the 6 months of follow-up
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
Time Frame: During the 6 months of follow-up
To evaluate consumption of unscheduled ambulatory care related to DRP
During the 6 months of follow-up
Number of medical consultations
Time Frame: During the 6 months of follow-up
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
Time Frame: During the 6 months of follow-up
To evaluate consumption of unscheduled ambulatory care related to DRP
During the 6 months of follow-up
Number of hospital admissions
Time Frame: During the 6 months of follow-up
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
Time Frame: At inclusion and 6 months from the treatment initiation
At inclusion and 6 months from the treatment initiation
Patient's satisfaction with treatment, measured with the SAT-MED Q questionnaire
Time Frame: At inclusion and 6 months from the treatment initiation
At inclusion and 6 months from the treatment initiation
Health locus of control, measured with the Therapeutic Self Care Toll (TSCT) scale
Time Frame: At inclusion and 6 months from the treatment initiation
At inclusion and 6 months from the treatment initiation
Number of interventions of primary care actors with the patient
Time Frame: During the 9 months of follow-up
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
Time Frame: During the 9 months of follow-up
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
Time Frame: During the 9 months of follow-up
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
Time Frame: During the 9 months of follow-up
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
Time Frame: During the 9 months of follow-up
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
Time Frame: At 9 months post-inclusion
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
Time Frame: At 9 months post-inclusion
Satisfaction will be measured with a 10-point visual analog scale.
At 9 months post-inclusion
Efficiency of the DROP program
Time Frame: 9 months post-inclusion
Efficiency will be computed by the incremental cost-efficacy ratio between the DROP program and the usual care.
9 months post-inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL17_0029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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