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The Effect of Education Brain Tumors (Education&BT)

29 maggio 2026 aggiornato da: Merve Nur Demiryürek, Istanbul University - Cerrahpasa

The Effect of the Education for Brain Tumor Patients and Their Caregivers on the Quality of Life and Care Burden

This study was designed to evaluate the impact of education programs for patients with primary brain tumors and their caregivers on quality of life and the burden of care experienced by caregivers.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Patients with brain tumors often face physical, cognitive, emotional, and behavioral challenges that negatively impact their quality of life (Townsley, 2014). A review of the literature indicates that, unlike patients with other types of cancer, brain tumor patients' greater dependence on others for daily activities causes stress for caregivers, increases the burden of care, and reduces caregivers' quality of life (Özdingiş, 2020; Maşalacı, 2017; Schubart et al., 2007; Olver et al., 2020; Cashman et al., 2019).

Previous studies have noted that nursing interventions for patients with primary brain tumors are limited; however, it has been observed that such interventions improve patients' cognitive and emotional well-being and reduce the care burden on caregivers (Halkett et al. 2018; Langbecker and Janda, 2015; Tokunaga et al., 2024). A review of the national literature on education and counseling provided by nurses to patients revealed a limited number of studies, which emphasized the need to also provide education to family members during the disease adaptation process (Baksi Şimşek, 2013). It is anticipated that the results of this study will contribute to nursing practices and research.

Hypotheses:

H1: The quality of life of patients with primary brain tumors who receive structured education is higher than that of patients who receive routine/standard education.

H2: The severity of symptoms in patients with primary brain tumors who receive structured education is lower than that of patients who receive routine/standard education.

H3: The quality of life of caregivers for patients with primary brain tumors who receive structured education is higher than that of caregivers for patients who receive routine/standard education.

H4: The burden of care for caregivers of patients with primary brain tumors who receive structured education is lower than that of caregivers for patients who receive routine/standard education.

Tipo di studio

Interventistico

Iscrizione (Stimato)

72

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

Backup dei contatti dello studio

Luoghi di studio

  • Turchia (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turchia (Türkiye), 34480
        • Reclutamento
        • Istanbul Basaksehir Cam and Sakura City Hospital
        • Investigatore principale:
          • Merve Nur Demiryürek, MSc Student
        • 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

No

Descrizione

Inclusion Criteria

For Patients

  • Aged >18 years
  • Undergoing primary brain tumor surgery for the first time
  • Glasgow Coma Scale score of 15
  • Able to assess and express symptoms
  • Literate in Turkish
  • No psychiatric history
  • Not using psychiatric medication
  • Willing to participate and provide consent

For Caregivers

  • Aged >18 years
  • Primary caregiver providing care for at least 3 months
  • Open to communication and cooperation
  • No psychiatric history
  • Not using psychiatric medication
  • Willing to participate and provide consent

Exclusion Criteria

  • Not meeting the inclusion criteria
  • Intubated patients
  • Patients with metastatic brain tumors
  • Patients with pituitary tumors

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: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Experimental: Intervention Group
Patients and caregivers in the experimental group will receive preoperative education structured according to the Nursing Life Model, which was developed based on the literature.The Roper-Logan-Tierney Nursing Model of Living is one of the most widely utilized frameworks in nursing practice. The primary aim of the model is to guide nurses in providing care through the assessment of an individual's activities of living.
Altro: structured training based on the Life Model in Nursing
Patients and caregivers in the experimental group will receive preoperative education structured according to the Nursing Life Model, which was developed based on the literature.The Roper-Logan-Tierney Nursing Model of Living is one of the most widely utilized frameworks in nursing practice. The primary aim of the model is to guide nurses in providing care through the assessment of an individual's activities of living.
Nessun intervento: No Intervention: Control Group
Patients and caregivers in this group will not receive any education other than the routine discharge training routinely provided in the clinic.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient's and caregiver quality of life
Lasso di tempo: before surgery, on the day 1 of discharge and 1 month after discharge
Quality of life will be assessed using the validated quality of life scales SF-12 and EQ-5D-5L. Assessments will be conducted preoperatively with SF-12 and EQ-5D-5L; on the day of discharge with EQ-5D-5L; and one month after discharge with SF-12 and EQ-5D-5L.
before surgery, on the day 1 of discharge and 1 month after discharge

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Caregivers caregiver Burden
Lasso di tempo: The patient will be evaluated before surgery, on the day 1 of discharge, and one month after discharge.

To assess changes following the training intervention, the caregiver's burden will be evaluated using the validated Caregiver Burden Scale.The scale, which can be completed either by the caregiver themselves or through an interviewer, consists of 22 items that determine the impact of caregiving on the caregiver's life. It uses a Likert-type response format ranging from 0 to 4, with options including never, rarely, sometimes, often, and nearly always. Studies have reported internal consistency reliability coefficients between 0.87 and 0.94, and test-retest reliability of 0.71. Scores on the scale range from 0 to 88, with higher scores indicating a greater level of burden experienced.

The Turkish validity and reliability study was conducted by Erdem and İnci in 2008, with reliability coefficients between 0.71 and 0.86, demonstrating high reliability.
The patient will be evaluated before surgery, on the day 1 of discharge, and one month after discharge.
Symptom burden
Lasso di tempo: Measurements will be taken before surgery, on the day 1 of discharge, and one month after discharge.
Symptom burden will be assessed using the MD Anderson Symptom Inventory - Brain Tumor Module. This validated tool measures the severity of brain tumor-related symptoms and their interference with daily activities. The inventory was developed by Armstrong et al., and all validity and reliability analyses were completed in 2006, with a total internal consistency reliability coefficient (Cronbach's alpha) of .91. The MDA-BT consists of two sections, seven subscales, and a total of 28 items, each rated individually on a Likert-type scale ranging from 0 to 10. The validity and reliability of the inventory for the Turkish population were established by Baksi and Dicle, yielding a Cronbach's alpha coefficient of .90.
Measurements will be taken before surgery, on the day 1 of discharge, and one month after discharge.

Collaboratori e investigatori

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

Sponsor

Istanbul University - Cerrahpasa

Investigatori

  • Investigatore principale: Merve Nur N Demiryürek, Istanbul University- Cerrahpasa Institute of Graduate Studies

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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 (Effettivo)

25 marzo 2026

Completamento primario (Stimato)

31 gennaio 2027

Completamento dello studio (Stimato)

31 dicembre 2027

Date di iscrizione allo studio

Primo inviato

24 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 maggio 2026

Primo Inserito (Effettivo)

1 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • E-96317027-514.10-286508325 (Altro identificatore: Istanbul University- Cerrahpasa)

Piano per i dati dei singoli partecipanti (IPD)

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

NO

Descrizione del piano IPD

Individual participant data will not be shared due to patient confidentiality and ethical considerations. Data will be used only for the purposes of this thesis study and will not be publicly available.

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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