- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07677176
Educational Intervention on Oral Anticancer Agents for Community Pharmacists: Pilot RCT
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 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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Min Xuan Tan PhD Candidate
- Telefonnummer: +60174419245
- E-mail: minxuan.tan@monash.edu
Studiesteder
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-
Selangor
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Subang Jaya, Selangor, Malaysia
- Monash University Malaysia
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Kontakt:
- Min Xuan Tan PhD Candidate
- Telefonnummer: +60174419245
- E-mail: minxuan.tan@monash.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention Group
Community pharmacists receive the educational intervention on oral anticancer agents.
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Participants attend an educational program on managing oral anticancer agents in community pharmacy setting.
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Ingen indgriben: Control Group
Community pharmacists continue with usual practice only, without the educational intervention.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility indicators composite
Tidsramme: Baseline to 4-week follow up
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Composite measure of five feasibility indicators:
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Baseline to 4-week follow up
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Acceptability of the intervention
Tidsramme: Immediately post-intervention
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Acceptability of the intervention will be measured by a satisfaction questionnaire.
Contents included participants' perceptions of the usefulness and satisfaction with the intervention.
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Immediately post-intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Knowledge of oral anticancer agents, confidence in managing oral anticancer agents
Tidsramme: Baseline (T1), immediately post-intervention (T2), and 4 weeks post-intervention (T3)
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Knowledge and confidence will be measured using a study questionnaire consisting of knowledge and confidence items regarding managing oral anticancer agents.
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Baseline (T1), immediately post-intervention (T2), and 4 weeks post-intervention (T3)
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- OAA-CP-PILOT-RCT-2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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