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Educational Intervention on Oral Anticancer Agents for Community Pharmacists: Pilot RCT

24 giugno 2026 aggiornato da: Monash University Malaysia

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Selangor
      • Subang Jaya, Selangor, Malaysia
        • Monash University Malaysia
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Nessun intervento: Control Group
Community pharmacists continue with usual practice only, without the educational intervention.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility indicators composite
Lasso di tempo: 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.
Baseline to 4-week follow up
Acceptability of the intervention
Lasso di tempo: Immediately post-intervention
Acceptability of the intervention will be measured by a satisfaction questionnaire. Contents included participants' perceptions of the usefulness and satisfaction with the intervention.
Immediately post-intervention

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Knowledge of oral anticancer agents, confidence in managing oral anticancer agents
Lasso di tempo: Baseline (T1), immediately post-intervention (T2), and 4 weeks post-intervention (T3)
Knowledge and confidence will be measured using a study questionnaire consisting of knowledge and confidence items regarding managing oral anticancer agents.
Baseline (T1), immediately post-intervention (T2), and 4 weeks post-intervention (T3)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 novembre 2026

Completamento dello studio (Stimato)

1 novembre 2026

Date di iscrizione allo studio

Primo inviato

24 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 giugno 2026

Primo Inserito (Effettivo)

30 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • OAA-CP-PILOT-RCT-2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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