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Набор скоро начнётся NCT07677176

Educational Intervention on Oral Anticancer Agents for Community Pharmacists

Без фазы С лечением Oral Anti-Tumor Drugs Oral Antineoplastic Agents Oral Anticancer Drugs

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Educational intervention on managing oral anticancer agents in community pharmacy setting.
Кому может быть актуально
Состояния в реестре: Oral Anti-Tumor Drugs, Oral Antineoplastic Agents, Oral Anticancer Drugs. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Малайзия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Feasibility and Acceptability of an Educational Intervention on Oral Anticancer Agents for Community Pharmacists: a Pilot Randomized Controlled Trial

Обзор

The overall aim of this study is to develop and test the feasibility and acceptability of an educational intervention for community pharmacists to provide support to patients receiving oral anticancer agents (OAAs) in the community. This pilot randomized controlled trial aims to evaluate the feasibility, acceptability, and preliminary effect of an educational intervention on the knowledge and confidence in managing OAAs among community pharmacists in Malaysia. PRIMARY OBJECTIVE • To evaluate the feasibility and acceptability of the educational intervention on OAAs among community pharmacists. SECONDARY OBJECTIVE • To obtain preliminary data on the effect of the educational intervention to improve community pharmacists' knowledge and confidence in managing OAAs. Participants will be randomly assigned to either the intervention group or control group in a 1:1 ratio using block randomization. After enrolling, participants will be asked to complete a baseline survey assessing their knowledge and confidence in managing OAAs. Immediately after completing the intervention and 4 weeks after the intervention, participants in the intervention group and control group will repeat the same questionnaire to assess changes in their knowledge and confidence. Results of this pilot study will inform the design of a larger study to test whether this intervention improves community pharmacists' knowledge and confidence. This research may help better prepare community pharmacists to provide high-quality care to patients receiving OAAs.

Подробное описание

BACKGROUND AND FRAMEWORK The educational intervention will be systematically developed using Intervention Mapping framework. The intervention will be designed to addresses identified gaps in knowledge and confidence among community pharmacists in managing OAAs, while also incorporating the views, needs and expectations of cancer patients receiving OAAs to ensure patient-centred care.

INTERVENTION DEVELOPMENT Stakeholder involvement will be incorporated throughout the development of the educational intervention. Key stakeholders include hospital pharmacists with experience in oncology field, community pharmacists with experience in dispensing OAAs, and pharmacy academics. Stakeholder input will be obtained to refine the content, structure, and delivery of the intervention and feedback will be used to refine the educational materials prior to implementation in the pilot trial.

CURRENT STUDY This pilot study represents UK Medical Research Council (MRC) phase 2 (feasibility and piloting) and follows CONSORT extension guidelines for pilot and feasibility trials.

STUDY DESIGN This is a randomized pilot feasibility study employing a mixed methods approach with parallel groups (intervention n=20, control n=20). The design compares community pharmacists receiving the educational intervention with pharmacists receiving no intervention.

INTERVENTION DESCRIPTION The intervention is an online educational program for community pharmacists focusing on providing support to patients receiving OAAs. Developed using the Intervention Mapping framework, the program addresses identified gaps in knowledge and confidence related to topics such as adverse effects, drug interactions, and patient counselling. The intervention will be delivered through an online workshop. Participants will engage in discussions and clinical case scenarios designed to enhance their knowledge and confidence to provide care for patients receiving OAAs.

DATA COLLECTION Data collection occurs at three timepoints: baseline (T1), immediately post-intervention (T2), and 4 weeks post-intervention (T3). Quantitative measures include knowledge, confidence, and feasibility indicators. Qualitative data include semi-structured interviews with community pharmacists and educators.

ETHICAL CONSIDERATIONS All participants provide written informed consent after receiving comprehensive study information. Participation is voluntary with the right to withdraw at any time.

SIGNIFICANCE This pilot study will provide important information on the feasibility and acceptability of the educational intervention and inform the design and implementation of a future definitive randomized controlled trial. The findings will contribute to the evidence base on oncology education for community pharmacists and help address existing gaps in knowledge and confidence for managing OAAs in community pharmacy practice. Ultimately, this may support the provision of quality care for patients receiving OAAs in the community.

Вмешательства

  • Другое Educational intervention on managing oral anticancer agents in community pharmacy setting
    Participants attend an educational program on managing oral anticancer agents in community pharmacy setting.

Первичные конечные точки

  • Feasibility indicators composite [Срок оценки: Baseline to 4-week follow up]
  • Acceptability of the intervention [Срок оценки: Immediately post-intervention]
Вторичные конечные точки (2)
  • Knowledge of oral anticancer agents [Срок оценки: Baseline (T1), immediately post-intervention (T2), and 4 weeks post-intervention (T3)]
  • Confidence in managing oral anticancer agents [Срок оценки: Baseline (T1), immediately post-intervention (T2), and 4 weeks post-intervention (T3)]

Критерии участия

Критерии включения

  • Currently a registered pharmacist working in community pharmacy in Malaysia
  • Provided written informed consent
  • Ability to read and understand English
  • Basic digital literacy and ability to use computer/tablet devices
  • Willingness to participate in all study procedures including surveys and potential interviews

Критерии исключения

  • Previous participation in educational intervention stakeholder evaluation

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Малайзия · 1 центр
  • Monash University Malaysia — Subang Jaya

Идентификаторы

NCT: NCT07677176 · OAA-CP-PILOT-RCT-2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗