- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Merve Nur Demiryürek, MSc Student
- 전화번호: +90 534 065 73 48
- 이메일: mervenurdemir16@gmail.com
연구 연락처 백업
- 이름: Aylin Özakgül, Mrs.
- 전화번호: +90 532 065 51 70
- 이메일: aylin.ozakgul@iuc.edu.tr
연구 장소
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Istanbul
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Istanbul, Istanbul, 터키 (Türkiye), 34480
- 모병
- Istanbul Basaksehir Cam and Sakura City Hospital
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수석 연구원:
- Merve Nur Demiryürek, MSc Student
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연락하다:
- Merve Nur N Demiryürek, MSc Student
- 전화번호: +90 534 065 73 48
- 이메일: mervenurdemir16@gmail.com
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient's and caregiver quality of life
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Caregivers caregiver Burden
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Merve Nur N Demiryürek, Istanbul University- Cerrahpasa Institute of Graduate Studies
간행물 및 유용한 링크
일반 간행물
- 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
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- E-96317027-514.10-286508325 (기타 식별자: Istanbul University- Cerrahpasa)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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