Pharmaceutical Care for Patients Using Capecitabine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-08-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer Colorectal Cancer Gi Capecitabine Pharmaceutical Services Adverse Drug Reaction (ADR)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants in the control group received pharmaceutical guidance at the time of dispensing capecitabine and participants in the intervention group received pharmaceutical care through consultations carried out on the dates scheduled for collection of capecitabine at the pharmacy.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group

Participants in the control group received pharmaceutical guidance at the time of dispensing capecitabine.

Group Type NO_INTERVENTION

No interventions assigned to this group

Pharmaceutical care

Participants in the intervention group received pharmaceutical care.

Group Type ACTIVE_COMPARATOR

Pharmaceutical Care

Intervention Type OTHER

Participants in the intervention group received pharmaceutical care

Interventions

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Pharmaceutical Care

Participants in the intervention group received pharmaceutical care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No