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| ID | Type | Description | Link |
|---|---|---|---|
| 5.313.716 | Other Identifier | INSTITUTO NACIONAL DE CANCER | |
| 5.855.089 | Other Identifier | UNIVERSIDADE FEDERAL DO RIO DE JANEIRO |
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| Name | Class |
|---|---|
| Universidade Federal Fluminense | OTHER |
| Instituto Nacional de Cancer, Brazil | OTHER_GOV |
| Universidade Federal do Rio de Janeiro | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Participants in the control group received pharmaceutical guidance at the time of dispensing capecitabine. | |
| Pharmaceutical care | Active Comparator | Participants in the intervention group received pharmaceutical care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmaceutical Care | Other | Participants in the intervention group received pharmaceutical care |
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| Measure | Description | Time Frame |
|---|---|---|
| Instruments and questionnaire | 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 | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmaceutical interventios | Number of pharmaceutical interventions performed | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CAMILLE C NIGRI, PhD | Universidade Federal do Rio de Janeiro | Principal Investigator |
| THAISA A NOGUEIRA, PhD | Universidade Federal Fluminense | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Cancer | Rio de Janeiro | Rio de Janeiro | 20231-030 | Brazil |
5.204.291
June 2025 - June 2029.
Results
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D010593 | Pharmaceutical Services |
| ID | Term |
|---|---|
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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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.
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| D009369 |
| Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D064419 | Chemically-Induced Disorders |