Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03257969

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

Led by Hospices Civils de Lyon · Updated on 2025-03-05

248

Participants Needed

1

Research Sites

376 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 18 years old or more
  • Diagnosed with cancer
  • Starting or changing an oral anticancer drug
  • Life expectancy of 6 months or more according to investigator
  • Expected treatment duration with oral anticancer drug of 6 months or more according to oncologist
  • Receiving oral anticancer drugs such as cytotoxic agents, targeted therapy, or hormonal therapy (excluding adjuvant treatments)
  • Oral anticancer drugs delivered by town pharmacy or hospital retrocession
  • Outpatient status (not hospitalized for treatment)
  • Taking 5 or more drugs including oral anticancer treatment and/or on complex oral anticancer regimen
  • Sufficient autonomy to manage medication at home
  • No cognitive or major psychiatric disorders according to investigator
  • Able to read, write, and understand French
  • Given written consent to participate
  • Affiliated with social security or equivalent
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women
  • Receiving anti-PD1, anti-PDL-1, or anti-CTLA4 immunotherapy with oral anticancer treatment
  • Receiving radiotherapy with oral anticancer treatment
  • Oral anticancer drug prescribed as part of an ATU or clinical trial delivery circuit
  • Significant cognitive or psychiatric disorders according to investigator
  • Medication management at home done exclusively by a caregiver
  • No declared doctor
  • No usual city pharmacy or using two or more city pharmacies
  • Previously participated in a therapeutic education program
  • Institutionalized, under guardianship, or legally protected

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Trial Site Locations

Total: 1 location

1

Service pharmaceutique, Unité de Pharmacie Clinique Oncologique, Centre Hospitalier Lyon Sud

Pierre-Bénite, France, 69310

Actively Recruiting

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Research Team

C

Catherine RIOUFOL, PharmD

CONTACT

L

Laure HUOT, PharmD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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