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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Number of DRP (Drug Relates Problems) related to oral anticancer drugs per patient, in total and for each category [Срок оценки: 9 months post-inclusion]

Вторичные конечные точки (12)

• Total number of DRP related to all prescribed drugs per patient [Срок оценки: 6 months and 9 months post-inclusion]
• Number of adaptations in the prescription of oral anticancer drugs, related to DRP, per patient [Срок оценки: 6 months and 9 months post-inclusion]
• Relative dose intensity of the oral anticancer drug [Срок оценки: 6 months post-inclusion]
• Adherence to the oral anticancer drug [Срок оценки: 6 months post-inclusion]
• Number of imaging acts and nature of acts [Срок оценки: During the 6 months of follow-up]
• Number of acts of biology and nature of acts [Срок оценки: During the 6 months of follow-up]
• Number of medical consultations [Срок оценки: During the 6 months of follow-up]
• Number of prescriptions of drugs (without prescription of the oral anticancer drug) and nature of these drugs [Срок оценки: During the 6 months of follow-up]
• Number of hospital admissions [Срок оценки: During the 6 months of follow-up]
• Patient's quality of life, measured with the EuroQol 5-Dimensions questionnaire [Срок оценки: At inclusion and 6 months from the treatment initiation]
• Patient's satisfaction with treatment, measured with the SAT-MED Q questionnaire [Срок оценки: At inclusion and 6 months from the treatment initiation]
• Health locus of control, measured with the Therapeutic Self Care Toll (TSCT) scale [Срок оценки: At inclusion and 6 months from the treatment initiation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Service pharmaceutique, Unité de Pharmacie Clinique Oncologique, Centre Hospitalier Lyon S — Pierre-Bénite

Публикации

• Ranchon F, Huot L, Bardin C, Madelaine I, Cazin JL, Pourroy B, Tilleul P, Lemare F, Rioufol C. Randomised controlled trial to assess the impact of hospital-community pharmaceutical care on drug-related problems in oncology practice for at-risk outpatients treated with oral anticancer drugs-a French Society for Oncology Pharmacy (SFPO) study: DROP-SFPO study protocol. BMJ Open. 2025 Jun 27;15(6):e0 PMID 40578885

Идентификаторы

NCT: NCT03257969 · 69HCL17_0029

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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