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Primary Brain NeoplasmsEducation&BTNCT07617168

The Effect of Education Brain Tumors

A study testing structured training based on the Life Model in Nursing in people with Primary Brain Neoplasms, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Brain Neoplasms
What is being tested?
structured training based on the Life Model in Nursing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Mar 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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

Who cannot join

  • Not meeting the inclusion criteria
  • Intubated patients
  • Patients with metastatic brain tumors
  • Patients with pituitary tumors

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Merve Nur Demiryürek, MSc Student contact

+90 534 065 73 48

mervenurdemir16@gmail.com

Aylin Özakgül, Mrs. contact

+90 532 065 51 70

aylin.ozakgul@iuc.edu.tr

Turkey (Türkiye)1 site, 1 recruiting

  • Istanbul Basaksehir Cam and Sakura City Hospital

    Istanbul, Istanbul, 34480

    Merve Nur N Demiryürek, MSc Student, +90 534 065 73 48, mervenurdemir16@gmail.com

    Merve Nur Demiryürek, MSc Student

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
structured training based on the Life Model in Nursing
Keywords
primary brain tumors, structed education, patients caregiver
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • structured training based on the Life Model in NursingOther

    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.

Study groups in NCT07617168
Study groupRoleWhat they receive
Experimental: Intervention GroupExperimentalPatients 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.
Receives: Other: structured training based on the Life Model in Nursing
No Intervention: Control GroupNo interventionPatients and caregivers in this group will not receive any education other than the routine discharge training routinely provided in the clinic.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient's and caregiver quality of life

    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.

    Measured: before surgery, on the day 1 of discharge and 1 month after discharge

Secondary outcomes (2)

  1. Caregivers caregiver Burden

    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.

    Measured: The patient will be evaluated before surgery, on the day 1 of discharge, and one month after discharge.

  2. Symptom burden

    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.

    Measured: Measurements will be taken before surgery, on the day 1 of discharge, and one month after discharge.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2026
  2. Study start25 Mar 2026
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to either the experimental group or the control group. While patients and caregivers in the experimental group will receive structured training based on the Life Model in Nursing, the control group will receive routine hospital care without any additional educational intervention. The results will be compared between these two parallel groups.
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07617168
Sponsor's protocol ID
E-96317027-514.10-286508325
Other IDs
E-96317027-514.10-286508325
Acronym
Education&BT
Status last verified
May 2026
First submitted
24 May 2026
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 40457375

  • 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.

    PubMed 25667919

  • 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.

    PubMed 28190236

  • 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.

    PubMed 31385998

  • 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.

    PubMed 32342221

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing structured training based on the Life Model in Nursing in people with Primary Brain Neoplasms, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Merve Nur Demiryürek, MSc Student (+90 534 065 73 48, mervenurdemir16@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient's and caregiver quality of life (time frame: before surgery, on the day 1 of discharge and 1 month after discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07617168, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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