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NCT Number: NCT07677176

Educational Intervention on Oral Anticancer Agents for Community Pharmacists

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.

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Key information

Conditions

Oral Anti-Tumor Drugs Oral Anticancer Drugs Oral Antineoplastic Agents

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility indicators composite

    Time frame: Baseline to 4-week follow up

    Composite measure of five feasibility indicators:

    • 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;
    • Retention rate: proportion of participants who completed each outcome assessment at three measurement timepoints;
    • Adherence rate: proportion of intervention group pharmacists who attended and completed the full educational program;
    • Attrition rate: proportion of participants who dropped out of the study after enrolment among all participants. Reasons for dropout will also be recorded.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Min Xuan Tan PhD Candidate

CONTACT

[email protected]

+60174419245

Sponsors and collaborators

Lead sponsor

Monash University Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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