- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07617168
The Effect of Education Brain Tumors (Education&BT)
The Effect of the Education for Brain Tumor Patients and Their Caregivers on the Quality of Life and Care Burden
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Merve Nur Demiryürek, MSc Student
- Numer telefonu: +90 534 065 73 48
- E-mail: mervenurdemir16@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Aylin Özakgül, Mrs.
- Numer telefonu: +90 532 065 51 70
- E-mail: aylin.ozakgul@iuc.edu.tr
Lokalizacje studiów
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Istanbul
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Istanbul, Istanbul, Turcja (Türkiye), 34480
- Rekrutacyjny
- Istanbul Basaksehir Cam and Sakura City Hospital
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Główny śledczy:
- Merve Nur Demiryürek, MSc Student
-
Kontakt:
- Merve Nur N Demiryürek, MSc Student
- Numer telefonu: +90 534 065 73 48
- E-mail: mervenurdemir16@gmail.com
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
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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.
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Brak interwencji: 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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Patient's and caregiver quality of life
Ramy czasowe: before surgery, on the day 1 of discharge and 1 month after discharge
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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.
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before surgery, on the day 1 of discharge and 1 month after discharge
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Caregivers caregiver Burden
Ramy czasowe: The patient will be evaluated before surgery, on the day 1 of discharge, and one month after discharge.
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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.
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Symptom burden
Ramy czasowe: Measurements will be taken before surgery, on the day 1 of discharge, and one month after discharge.
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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.
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Measurements will be taken before surgery, on the day 1 of discharge, and one month after discharge.
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Merve Nur N Demiryürek, Istanbul University- Cerrahpasa Institute of Graduate Studies
Publikacje i pomocne linki
Publikacje ogólne
- Baksi Şimşek, A. (2013). An Examination of Adaptive and Maladaptive Behaviours in Patients with Primary Brain Tumours Using the Roy Adaptation Model, and the Effect of Education on Symptoms and Coping, PhD Thesis. Dokuz Eylül University Institute of Health Sciences.
- Tokunaga R, Sakaki M, Kashiwa S, Hayashi N. Rehabilitation nursing for brain tumor patients: a scoping review. BMC Med Educ. 2025 Jun 2;25(1):821. doi: 10.1186/s12909-025-07423-0.
- Langbecker D, Janda M. Systematic review of interventions to improve the provision of information for adults with primary brain tumors and their caregivers. Front Oncol. 2015 Jan 23;5:1. doi: 10.3389/fonc.2015.00001. eCollection 2015.
- Halkett GKB, Lobb EA, Miller L, Shaw T, Moorin R, Long A, King A, Clarke J, Fewster S, Nowak AK. Feasibility Testing and Refinement of a Supportive Educational Intervention for Carers of Patients with High-Grade Glioma - a Pilot Study. J Cancer Educ. 2018 Oct;33(5):967-975. doi: 10.1007/s13187-017-1175-x.
- Philip J, Collins A, Staker J, Murphy M. I-CoPE: A pilot study of structured supportive care delivery to people with newly diagnosed high-grade glioma and their carers. Neurooncol Pract. 2019 Jan;6(1):61-70. doi: 10.1093/nop/npy010. Epub 2018 May 19.
- Olver I, Keefe D, Herrstedt J, Warr D, Roila F, Ripamonti CI. Supportive care in cancer-a MASCC perspective. Support Care Cancer. 2020 Aug;28(8):3467-3475. doi: 10.1007/s00520-020-05447-4. Epub 2020 Apr 27.
- Maşalacı, E (2017). Symptom Assessment in Patients with Primary Brain Tumors, Master's Thesis. Gazi University Institute of Health Sciences, Ankara.
- Özdingiş, Ş.Ö. (2020). An Investigation of Factors Affecting Quality of Life in Patients with Brain Tumors Presenting to a Foundation University Hospital, Master's Thesis. Yeditepe University Institute of Health Sciences, Istanbul.
- Townsley, E. (2014). Evidence-Based Practice in Neurological Nursing. Translated by H. Kaya. Nobel Medical Publishers, Istanbul, 331-332
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- E-96317027-514.10-286508325 (Inny identyfikator: Istanbul University- Cerrahpasa)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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