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The overall aim of this study is to develop and test the feasibility and acceptability of an educational intervention for community pharmacists to help them support patients receiving OAAs in the community setting. This pilot randomized controlled trial aims to evaluate the feasibility, acceptability, and preliminary effect of an educational intervention on the knowledge and readiness 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 effectiveness 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 about managing OAAs. Immediately after completing the intervention, participants in the intervention 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 definitively test whether this intervention improves community pharmacists' knowledge and readiness. This research may help better prepare community pharmacists to provide high-quality care to patients receiving OAAs.
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 needs and expectations of cancer patients to ensure patient-centred care.
INTERVENTION DEVELOPMENT The intervention will be co-designed through multidisciplinary collaboration with pharmacy educators, oncology clinical pharmacists, and community pharmacists. The intervention content will be validated by the expert panel, which included oncologist, oncology clinical pharmacists, and pharmacy educators. Stakeholder input will be obtained to refine the content, structure, and delivery of the intervention. Usability of the intervention will be evaluated during the development process, and feedback will be used to iteratively refine the educational materials and delivery format prior to implementation in the pilot trial.
CURRENT STUDY This pilot feasibility study represents 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=15, control n=15). 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 the management of OAAs. The intervention will be developed through a co-design process involving the principal investigator, pharmacy educator, community pharmacist, and an experienced clinical pharmacist in oncology field, ensuring both pedagogical soundness and clinical authenticity. Developed using the Intervention Mapping framework, the program addresses identified knowledge and readiness gaps related to OAA adverse effect, drug interactions, and patient counselling. The intervention will be delivered through online lectures and interactive case-based workshops. Participants will engage in discussions and clinical 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, readiness, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Community pharmacists receive the educational intervention on oral anticancer agents. |
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| Control Group | No Intervention | Community pharmacists continue with usual practice only, without the educational intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational intervention on managing oral anticancer agents in community pharmacy setting | Other | Participants attend an educational program on managing oral anticancer agents in community pharmacy setting. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility indicators composite | Composite measure of five feasibility indicators:
| Baseline to 4-week follow up |
| Acceptability of the 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. | Immediately post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge of oral anticancer agents | Measured using a questionnaire which assessed the knowledge and confidence regarding managing oral anticancer agents. The questionnaire consists of 3 items on self-perceived knowledge and 10 items on objective knowledge of OAAs. The self-perceived knowledge will be evaluated using a 5-point Likert scale (1 = very poor, 2 = poor, 3 = acceptable, 4 = good, 5 = very good). The total score will range from 3 to 15, with higher score indicating higher level of perceived knowledge. The objective knowledge questions will be scored on a numeric scale ranging from 0 to 10, where higher scores indicate better knowledge of OAAs. |
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Inclusion Criteria:
Exclusion Criteria:
• Previous participation in educational intervention stakeholder evaluation
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Xuan Tan PhD Candidate | Contact | +60174419245 | minxuan.tan@monash.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monash University Malaysia | Subang Jaya | Selangor | Malaysia |
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Two-arm pilot randomised controlled trial with an experimental and control group
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| Baseline (T1), immediately post-intervention (T2), and 4 weeks post-intervention (T3) |
| Confidence in managing oral anticancer agents | Measured using a questionnaire which assessed the knowledge and confidence regarding managing oral anticancer agents. The questionnaire consists of 4 items on the self-reported confidence to manage OAAs. The items will be evaluated using a 5-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree). The total score will range from 4 to 20, where higher score indicating higher confidence. | Baseline (T1), immediately post-intervention (T2), and 4 weeks post-intervention (T3) |