The Effect of Education Brain Tumors
ConditionPrimary Brain Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstanbul University - Cerrahpasa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged >18 years
Undergoing primary brain tumor surgery for the first time
Glasgow Coma Scale score of 15
Able to assess and express symptoms
Disqualifiers
Not meeting the inclusion criteria
Intubated patients
Patients with metastatic brain tumors
Patients with pituitary tumors
Trial design
Design model
Parallel
Treatments tested in this trial
structured training based on the Life Model in Nursing
Other interventionPatients 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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Experimental: Intervention GroupExperimental treatment 1 intervention
Group B: No Intervention: Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
before surgery, on the day 1 of discharge and 1 month after dischargeSecondary outcomes
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.
Time frame
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.
Time frame
Measurements will be taken before surgery, on the day 1 of discharge, and one month after discharge.Sponsors and contacts
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Source ClinicalTrials.gov