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

NCT03257969 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2025-03-05

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-18
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03257969 on ClinicalTrials.gov