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临床试验/NCT07063706
NCT07063706已完成不适用

Impact of Pharmaceutical Care on Patients Using Capecitabine: a Multicenter Randomized Clinical Trial

Faculdade de Farmácia2 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2022年3月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
176
试验地点
2
主要终点
Instruments and questionnaire

研究概览

简要总结

This is a longitudinal, prospective and intervention study, which will be carried out with patients undergoing treatment with capecitabine, where the impact of pharmaceutical care will be evaluated.

详细描述

Pharmaceutical care (PC) is a professional service in which the pharmacist, actively and in direct interaction with the patient, seeks to achieve concrete health results through the use of medications that improve their quality of life, considering their socioeconomic and cultural context. Through the practice of PC, it becomes possible to detect drug-related problems (DRPs), in addition to the possibility of preventing and resolving negative outcomes associated with the drug (NMR). With recent advances in cancer treatment, the increasing use of oral antineoplastic agents has accelerated. Despite the advantages involved in the use of oral chemotherapy compared to intravenous chemotherapy, there are associated risks that can compromise patient safety and the effectiveness of anticancer therapy. PC as a strategy to ensure and promote the safe and rational use of oral antineoplastics has been increasingly used in the care of cancer patients.

This is a longitudinal, prospective, interventional study that will be conducted with patients undergoing treatment with capecitabine. The study will last 30 months, from March 1, 2022 to August 30, 2024. The study will be conducted in two reference centers for oncology treatment in the city of Rio de Janeiro.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients initiating treatment with capecitabine, either: as monotherapy, or in combination with other antineoplastic therapies and/or radiotherapy.
  • No restrictions regarding therapeutic regimen or disease stage.
  • Age 18 years or older.
  • Patients being followed at one or both of the following institutions: Hospital do Câncer I of the National Cancer Institute (INCA), and/or Clementino Fraga Filho University Hospital (UFRJ).

排除标准

  • Patients who have previously started capecitabine treatment, with more than one full cycle completed prior to enrollment.
  • Inability to communicate verbally or significant difficulty in understanding that prevents adherence to pharmaceutical care instructions.
  • Refusal or inability to sign the Informed Consent Form.
  • Participation in another clinical study that may interfere with outcomes related to pharmaceutical care.
  • Any clinical condition that, in the investigator's judgment, may compromise full participation in the study.

结局指标

主要结局

Instruments and questionnaire

时间窗: Up to 6 months

Assessment of the clinical benefits of pharmaceutical care, measured by the variation in participants' quality of life between the beginning and end of treatment with capecitabine

次要结局

  • Pharmaceutical interventios(Up to 6 months)

研究者

发起方
Faculdade de Farmácia
申办方类型
Other
责任方
Sponsor

研究点 (2)

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