Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

The Effect of Education Brain Tumors (Education&BT)

29. mai 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

72

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

    • Istanbul
      • Istanbul, Istanbul, Tyrkia (Türkiye), 34480
        • Rekruttering
        • Istanbul Basaksehir Cam and Sakura City Hospital
        • Hovedetterforsker:
          • Merve Nur Demiryürek, MSc Student
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient's and caregiver quality of life
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Caregivers caregiver Burden
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. mars 2026

Primær fullføring (Antatt)

31. januar 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

24. mai 2026

Først innsendt som oppfylte QC-kriteriene

29. mai 2026

Først lagt ut (Faktiske)

1. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere