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Educational Intervention on Oral Anticancer Agents for Community Pharmacists

13. Juli 2026 aktualisiert von: 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 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Intervention Group
Community pharmacists receive the educational intervention on oral anticancer agents.
Sonstiges: Educational intervention on managing oral anticancer agents in community pharmacy setting
Participants attend an educational program on managing oral anticancer agents in community pharmacy setting.
Kein Eingriff: Control Group
Community pharmacists continue with usual practice only, without the educational intervention.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Feasibility indicators composite
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Knowledge of oral anticancer agents
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Monash University Malaysia

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2026

Studienabschluss (Geschätzt)

1. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

24. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Juni 2026

Zuerst gepostet (Tatsächlich)

30. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Juli 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • OAA-CP-PILOT-RCT-2026

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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