NCT07617168

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Mar 2026Dec 2027

Study Start

First participant enrolled

March 25, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

May 24, 2026

Last Update Submit

May 29, 2026

Conditions

Keywords

primary brain tumorsstructed educationpatients caregiver

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

  • Caregivers caregiver Burden

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

  • Symptom burden

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

Study Arms (2)

Experimental: Intervention Group

EXPERIMENTAL

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

No Intervention: Control Group

NO INTERVENTION

Patients and caregivers in this group will not receive any education other than the routine discharge training routinely provided in the clinic.

Interventions

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.

Experimental: Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • Intubated patients
  • Patients with metastatic brain tumors
  • Patients with pituitary tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Basaksehir Cam and Sakura City Hospital

Istanbul, Istanbul, 34480, Turkey (Türkiye)

RECRUITING

Related Publications (9)

  • 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.

    BACKGROUND
  • 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.

    PMID: 40457375BACKGROUND
  • 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.

    PMID: 25667919BACKGROUND
  • 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.

    PMID: 28190236BACKGROUND
  • 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.

    PMID: 31385998BACKGROUND
  • 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.

    PMID: 32342221BACKGROUND
  • Maşalacı, E (2017). Symptom Assessment in Patients with Primary Brain Tumors, Master's Thesis. Gazi University Institute of Health Sciences, Ankara.

    BACKGROUND
  • 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.

    BACKGROUND
  • Townsley, E. (2014). Evidence-Based Practice in Neurological Nursing. Translated by H. Kaya. Nobel Medical Publishers, Istanbul, 331-332

    BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Nursing

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Merve Nur N Demiryürek

    Istanbul University- Cerrahpasa Institute of Graduate Studies

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Merve Nur Demiryürek, MSc Student

CONTACT

Aylin Özakgül, Mrs.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc Student

Study Record Dates

First Submitted

May 24, 2026

First Posted

June 1, 2026

Study Start

March 25, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations