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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-18

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Observational Study to Assess Adherence Oral Anticancer Therapies

NCT03195972

Adherence, Patient

COMPLETED

Impact of Clinical Pharmacy Consultations in Patients With Cancer Treated With Oral Anti-cancer Therapies on the Rate of Serious Adverse Events

NCT02733965

Oral Anticancer Therapy.

UNKNOWN NA

Role of the Pharmacist in Detection of Drug Interactions Before Antitumor Treatment Initiation

NCT04142567

Neoplasm

COMPLETED

Impact of Hospital Pharmacist on Drug Management in Patients With Bronchopulmonary Cancer

NCT06469957

Patients With Bronchopulmonary Cancer

ACTIVE_NOT_RECRUITING

Optimizing the Management of Patients With Oral Therapy

NCT03623490

Kidney Cancer Breast Cancer

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The DROP program

Group Type EXPERIMENTAL

The DROP program of pharmaceutical interventions

Intervention Type BEHAVIORAL

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

Group Type OTHER

Standard of care

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No