Oral Anti-Tumor DrugsNCT07677176
Educational Intervention on Oral Anticancer Agents for Community Pharmacists
A study testing Educational intervention on managing oral anticancer agents in community pharmacy setting in people with Oral Anti-Tumor Drugs and Oral Antineoplastic Agents, run by Monash University Malaysia at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Anti-Tumor Drugs, Oral Antineoplastic Agents, Oral Anticancer Drugs
- What is being tested?
- Educational intervention on managing oral anticancer agents in community pharmacy setting
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMalaysia
- Study dates
- Aug 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous participation in educational intervention stakeholder evaluation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Monash University Malaysia
Subang Jaya, Selangor
Min Xuan Tan PhD Candidate, +60174419245, minxuan.tan@monash.edu
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Educational intervention on managing oral anticancer agents in community pharmacy setting
- Keywords
- Community pharmacists, Oral anticancer agents, Educational intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational intervention on managing oral anticancer agents in community pharmacy settingOther
Participants attend an educational program on managing oral anticancer agents in community pharmacy setting.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Community pharmacists receive the educational intervention on oral anticancer agents. Receives: Other: Educational intervention on managing oral anticancer agents in community pharmacy setting |
| Control Group | No intervention | Community pharmacists continue with usual practice only, without the educational intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility indicators composite
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.
Measured: 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.
Measured: Immediately post-intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline (T1), immediately post-intervention (T2), and 4 weeks post-intervention (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Anti-Tumor DrugsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm pilot randomised controlled trial with an experimental and control group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monash University Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677176
- Sponsor's protocol ID
- OAA-CP-PILOT-RCT-2026
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of an Educational Intervention on Oral Anticancer Agents for Community Pharmacists: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07677176
- Acronym / sponsor ID
- OAA-CP-PILOT-RCT-2026
- Keywords
- Community pharmacists, Oral anticancer agents, Educational intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Monash University MalaysiaUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm pilot randomised controlled trial with an experimental and control group
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Educational intervention on managing oral anticancer agents in community pharmacy settingCommunity pharmacists receive the educational intervention on oral anticancer agents. |
| Control Group | No intervention | –Community pharmacists continue with usual practice only, without the educational intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Previous participation in educational intervention stakeholder evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational intervention on managing oral anticancer agents in community pharmacy settingParticipants attend an educational program on managing oral anticancer agents in community pharmacy setting. | Other | Intervention Group |
Primary outcome
Feasibility indicators composite
Time frame: 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
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.
2 secondary outcomes
Knowledge of oral anticancer agents
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention on managing oral anticancer agents in community pharmacy setting in people with Oral Anti-Tumor Drugs and Oral Antineoplastic Agents, run by Monash University Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Xuan Tan PhD Candidate (+60174419245, minxuan.tan@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility indicators composite (time frame: Baseline to 4-week follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.