Adverse Drug Reaction (ADR), Cancer Colorectal, Cancer Gi, Capecitabine, Pharmaceutical Services
Conditions
Keywords
capecitabine, pharmaceutical services, quality of life, adverse effects
Brief summary
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.
Detailed description
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.
Interventions
OTHERPharmaceutical Care
Participants in the intervention group received pharmaceutical care
Sponsors
Universidade Federal Fluminense
Instituto Nacional de Cancer, Brazil
Universidade Federal do Rio de Janeiro
Faculdade de Farmácia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Instruments and questionnaire | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmaceutical interventios | Up to 6 months | Number of pharmaceutical interventions performed |
Countries
Brazil
Outcome results
None listed