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Indvirkning af farmaceutledet indgriben på voksne onkologiske ambulante patienter

27. september 2026 opdateret af: Eman Said Sawan, Badr University

Indvirkning af farmaceutledet medicinafstemning, rådgivning og opfølgning på medicinadhærens, medicinfejl og medicinrelateret indlæggelse hos voksne kræftpatienter i ambulant behandling

Background and Rationale: Cancer patients receiving outpatient therapy often manage complex medication regimens that include anticancer agents, supportive care medications, and treatments for chronic comorbidities. This polypharmacy greatly increases the risk of medication discrepancies, potential drug-drug interactions, and unintentional errors. Moreover, because most oncology care is delivered in outpatient settings, patients are primarily responsible for self-administering their medications, making adherence a key determinant of treatment success and patient safety (Lindenmeyer et al., 2022; Alshehri et al., 2024). Medication errors and poor adherence among oncology patients are widely recognized global concerns. Research indicates that nearly half of cancer patients experience at least one medication discrepancy during transitions of care, and nonadherence to oral anticancer therapies can exceed 40%. Such issues can result in reduced treatment efficacy, increased toxicity, avoidable hospitalizations, higher healthcare costs, and poorer quality of life (Weingart et al., 2018; Wu et al., 2020; Patel et al., 2021). Pharmacists, as essential members of the multidisciplinary oncology team, are uniquely positioned to address these medication-related challenges. Their pharmacotherapy expertise and patient-education roles enable them to detect discrepancies, optimize medication use, and enhance patient understanding of treatment regimens. Evidence from various healthcare settings shows that pharmacist-led interventions such as medication reconciliation, individualized counseling, and structured follow-up can improve medication safety and adherence (de Clercq et al., 2021; Boeni et al., 2022). Despite strong evidence supporting each of these interventions individually, few studies have examined the combined effect of pharmacist-led reconciliation, counseling, and follow-up in outpatient oncology practice. Adult cancer patients face additional challenges, including complex dosing schedules, emotional distress, and financial burdens, all of which can impair medication adherence. An integrated pharmacist led program may create a continuous safety net that detects medication discrepancies early, reinforces correct use, and sustains adherence throughout treatment (Gellad et al., 2022; ISPOR Report, 2023). Therefore, this study aims to evaluate the impact of a comprehensive pharmacist-led program encompassing medication reconciliation, individualized counseling, and systematic follow-up on enhancing medication adherence and reducing medication errors among adult outpatient cancer patients. Demonstrating the effectiveness of this integrated care model may provide strong evidence to support the routine inclusion of pharmacists in outpatient oncology services to improve patient outcomes and medication safety (Alshehri et al., 2024; Boeni et al., 2022).

Study Hypothesis: Adult oncology outpatients are frequently prescribed complex medication regimens upon leaving the hospital. Therefore, this study aims to evaluate whether a comprehensive pharmacist-led outpatient program improves medication adherence and reduces medication errors among this population.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

81

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Dr
      • Cairo, Dr, Egypten, 11829
        • Badr University in Cairo
      • Cairo, Dr, Egypten, 11829
        • National Cancer Institute, Cairo University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • • Adult medical oncology outpatient at NCI, Cairo University with different diagnoses.

    • Receiving ≥5 medication

Exclusion criteria:

  • Cognitive impairment,
  • Palliative care
  • Language barriers

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: PH-LED

Pharmacist led intervention

Medication Reconciliation, Counseling and Follow-Up

Aktiv komparator: ST- CARE

Standard care

Counselling

Andre navne:
  • Standardpleje

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
medication adherence
Tidsramme: at baseline and after ONE MONTH

• To measure medication adherence score in both groups using the Morisky (MMAS-8) scale at baseline and after one month to assess improvement in adherence after the pharmacist-led intervention compared to usual care where 8 = High adherence, 6 to <8 = Medium adherence

,<6 = Low adherence

at baseline and after ONE MONTH

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Detection of medication errors
Tidsramme: Number of medication errors within ONE MONTH from baseline

• To identify and detect the number of medication errors in both groups

Number of medication errors within ONE MONTH from baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

  • References: Alshehri, M., Althumairi, A., Alharbi, K., & Alharbi, F. (2024). The impact of pharmacist-led medication reconciliation on patient safety outcomes: A systematic review. International Journal of Medical Toxicology and Legal Medicine, 27(2), 87-95. Boeni, F., Spinatsch, M., Suter, K., Hersberger, K. E., & Arnet, I. (2022). Effectiveness of pharmacist-led counseling on medication adherence in cancer outpatients: A systematic review and meta-analysis. Journal of Oncology Pharmacy Practice, 28(5), 1123-1134. de Clercq, L., Van Camp, Y., De Winter, S., & Simoens, S. (2021). Pharmacist-led medication review and reconciliation in oncology: A scoping review. International Journal of Clinical Pharmacy, 43(4), 929-940. Gellad, W. F., Zhao, X., Thorpe, C. T., & Donohue, J. M. (2022). Pharmacist interventions to improve medication use and safety in oncology outpatients. BMC Health Services Research, 22(1), 1147. Hasen G, Negeso B. Patients Satisfaction with Pharmaceutical Care and Associated Factors in the Southwestern Ethiopia. Patient Prefer Adherence. 2021 Sep 21;15:2155-2163. doi: 10.2147/PPA.S332489. PMID: 34584408; PMCID: PMC8464365 ISPOR Report. (2023). Pharmacist-led interventions to improve medication adherence in cancer patients: A systematic review. Value in Health, 26(Suppl 1), S123-S131. Joy AM, UP N, Chand S, Shetty JK, George SM, Chacko CS, Joel JJ. Role of clinical pharmacist in the medication adherence behaviour of cancer patients: An interventional study. Le Pharmacien Hospitalier et Clinicien. 2021; 56:291-297. Lindenmeyer, A., Oliveira, T., Santos, R., & Mendes, E. (2022). Medication discrepancies among oncology patients: The importance of pharmacist involvement. Journal of Hospital Pharmacy Services, 9(3), 55-63. Patel, J., Wong, A., & Clark, C. (2021). Medication errors and patient outcomes in ambulatory oncology. American Journal of Health-System Pharmacy, 78(14), 1275-1282. Weingart, S. N., Brown, E., Bach, P. B., Engelhardt, K. E., Johnson, S

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2026

Primær færdiggørelse (Faktiske)

1. august 2026

Studieafslutning (Faktiske)

1. september 2026

Datoer for studieregistrering

Først indsendt

20. april 2026

Først indsendt, der opfyldte QC-kriterier

20. april 2026

Først opslået (Faktiske)

24. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • HOSPITAL2601-511-149-206

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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