- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07677176
Educational Intervention on Oral Anticancer Agents for Community Pharmacists
Feasibility and Acceptability of an Educational Intervention on Oral Anticancer Agents for Community Pharmacists: a Pilot Randomized Controlled Trial
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Min Xuan Tan PhD Candidate
- Phone Number: +60174419245
- Email: minxuan.tan@monash.edu
Study Locations
-
-
Selangor
-
Subang Jaya, Selangor, Malaysia
- Monash University Malaysia
-
Contact:
- Min Xuan Tan PhD Candidate
- Phone Number: +60174419245
- Email: minxuan.tan@monash.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
• Previous participation in educational intervention stakeholder evaluation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Community pharmacists receive the educational intervention on oral anticancer agents.
|
Participants attend an educational program on managing oral anticancer agents in community pharmacy setting.
|
|
No Intervention: Control Group
Community pharmacists continue with usual practice only, without the educational intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility indicators composite
Time Frame: Baseline to 4-week follow up
|
Composite measure of five feasibility indicators:
|
Baseline to 4-week follow up
|
|
Acceptability of the intervention
Time Frame: 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.
|
Immediately post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge of oral anticancer agents
Time Frame: Baseline (T1), immediately post-intervention (T2), and 4 weeks post-intervention (T3)
|
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.
|
Baseline (T1), immediately post-intervention (T2), and 4 weeks post-intervention (T3)
|
|
Confidence in managing oral anticancer agents
Time Frame: Baseline (T1), immediately post-intervention (T2), and 4 weeks post-intervention (T3)
|
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)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- OAA-CP-PILOT-RCT-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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