Drug Induced Dyskinesia Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Service pharmaceutique, Unité de Pharmacie Clinique Oncologique, Centre Hospitalier Lyon Sud
RECRUITING
Pierre-bénite
Contact Information
Primary
Catherine RIOUFOL, PharmD
catherine.rioufol@chu-lyon.fr
04 78 86 43 70
Backup
Laure HUOT, PharmD
laure.huot@chu-lyon.fr
04 72 11 57 62
Time Frame
Start Date: 2019-06-18
Estimated Completion Date: 2026-09
Participants
Target number of participants: 248
Treatments
Experimental: The DROP program
Other: Standard of care
Related Therapeutic Areas
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov