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The Effect of Education Brain Tumors (Education&BT)

29 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

72

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

    • Istanbul
      • Istanbul, Istanbul, Turkije (Türkiye), 34480
        • Werving
        • Istanbul Basaksehir Cam and Sakura City Hospital
        • Hoofdonderzoeker:
          • Merve Nur Demiryürek, MSc Student
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
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.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient's and caregiver quality of life
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Caregivers caregiver Burden
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

25 maart 2026

Primaire voltooiing (Geschat)

31 januari 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

24 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 mei 2026

Eerst geplaatst (Werkelijk)

1 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

29 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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