The Effect of Education Brain Tumors (Education&BT)

May 29, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34480
        • Recruiting
        • Istanbul Basaksehir Cam and Sakura City Hospital
        • Principal Investigator:
          • Merve Nur Demiryürek, MSc Student
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's and caregiver quality of life
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregivers caregiver Burden
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 24, 2026

First Submitted That Met QC Criteria

May 29, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-96317027-514.10-286508325 (Other Identifier: Istanbul University- Cerrahpasa)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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