Feasibility and Acceptability of an Educational Intervention on Oral Anticancer Agents for Community Pharmacists: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility indicators composite
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •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
排除标准
- •Previous participation in educational intervention stakeholder evaluation
研究组 & 干预措施
Control Group
Community pharmacists continue with usual practice only, without the educational intervention.
Intervention Group
Community pharmacists receive the educational intervention on oral anticancer agents.
干预措施: Educational intervention on managing oral anticancer agents in community pharmacy setting (Other)
结局指标
主要结局
Feasibility indicators composite
时间窗: Baseline to 4-week follow up
Composite measure of five feasibility indicators: 1. Recruitment: proportion of pharmacists who consent to participate in the study out of those who were approached and were eligible for participation. Time required to recruit target number of participants; 2. Retention rate: proportion of participants who completed each outcome assessment at three measurement timepoints; 3. Adherence rate: proportion of intervention group pharmacists who attended and completed the full educational program; 4. Attrition rate: proportion of participants who dropped out of the study after enrolment among all participants. Reasons for dropout will also be recorded.
Acceptability of the intervention
时间窗: Immediately post-intervention
Acceptability of the intervention will be measured by a satisfaction questionnaire developed by the research team. The questionnaire included 14 items and 2 optional open-ended questions. The questionnaire explored participants' perceptions of the usefulness and satisfaction with the intervention. The items will be evaluated using a 5-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = uncertainty, 4 = agree, 5 = strongly agree), with higher score indicating better acceptability.
次要结局
- Knowledge of oral anticancer agents, confidence in managing oral anticancer agents(Baseline (T1), immediately post-intervention (T2), and 4 weeks post-intervention (T3))
- Knowledge of oral anticancer agents(Baseline (T1), immediately post-intervention (T2), and 4 weeks post-intervention (T3))
- Confidence in managing oral anticancer agents(Baseline (T1), immediately post-intervention (T2), and 4 weeks post-intervention (T3))