Clinical trial NCT05328739: The Effect of Home Care Planned According to Orem in Patients With Primary Brain Tumor and Their Caregivers
Official title: The Effect of Planned Homecare According to Orem on the Self-care Agency and Care Burden in Patients With Primary Brain Tumors and Caregivers: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Brain Tumor
Caregiver Burden
Self Care
Keywords: caregiver burden
primary brain tumor
home care
self care agency
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was conducted to evaluate the effect of home care planned according to Orem on self-care agency and care burden in brain tumor patients and their caregivers. The study was performed with patients who underwent surgery for a brain tumor and their caregivers in the neurosurgery clinic of a tertiary hospital. Ethical committee approval, institutional permission, patients and their caregiver verbal and written consent were obtained. According to Orem's nursing theory, home care practice combining education, counseling and nursing care started with pre-operative education in the hospital for the patients and caregivers in the intervention group and continued at home with 5 home visits in a 6-month period. Self-Care Agency Scale, MD Anderson Symptom Inventory Brain Tumor-Turkish Form and Caregiver Burden Scale were used as measurement tools in the study.The value of p\<0.05 was accepted statistically significant in the data analyses.

Detailed description: In this randomized controlled experimental study, it was aimed to determine the effect of home care planned according to Orem on self-care agency and care burden in brain tumor patients and their caregivers. The study was performed with patients who underwent surgery for a brain tumor and their caregivers in the neurosurgery clinic of a tertiary hospital. Ethical committee approval, institutional permission, patients and their caregiver verbal and written consent were obtained. According to Orem's nursing theory, home care practice combining education, counseling and nursing care started with pre-operative education in the hospital for the patients and caregivers in the intervention group and continued at home with 5 home visits in a 6-month period. Self-Care Agency Scale, MD Anderson Symptom Inventory Brain Tumor-Turkish Form and Caregiver Burden Scale were used as measurement tools in the study. In addition, measurement tools used in patients and caregivers were applied to an average of 6 month: before surgery preoperative assessment at hospital (Time 1), after surgery 1st month at home (Time 2) after surgery 3rd month at home (Time 3) and after surgery 6th month at home (Time 4). Data were analyzed with descriptive statistics, two-way analysis of variance. Bonferroni correction was applied when comparing the main effects and comparisons between categorical variables and groups were evaluated with Fisher's exact test, p\<.05 value was considered statistically significant.

Eligibility criteria: inclusion criteria for patient;

* living within the borders of the region,
* being over 18 years old,
* being at least literate, being able to communicate in Turkish,
* being oriented to person, place and time, not having hearing and speaking problems,
* having primar brain tumor (glial or meningeal) surgery,
* taking part in grade I, II, III
* and having Karnovsky Performance Scale (KPS) score above 50 points.

exclusion criteria for patient;

* being under the age of 18,
* illiterate, unable to communicate in Turkish,
* being diagnosed with a neurological and psychiatric disorder that may affect the cognitive status,
* not being oriented to the person, place and time, having hearing and speaking problems,
* having surgery for a metastatic brain tumor,
* having surgery for a pituitary adenoma, to have undergone emergency surgery, to have a biopsy,
* to be in grade IV,
* to have a KPS score below 50 points.

Criteria for terminating the research process;

* wanting to leave the research process,
* meeting one of the criteria for exclusion from the sample after the surgery,
* spending the home care and follow-up process in another province, and/or not being able to reach the individual.

inclusion criteria for caregiver;

* being over the age of 18,
* being literate, being able to communicate in Turkish, and not having hearing and speaking problems,
* caring for a patient who had primary brain tumor surgery.

exclusion criteria for caregiver ;

* being under the age of 18,
* illiterate, unable to communicate in Turkish,
* being diagnosed with a neurological or psychiatric disorder that may affect the cognitive status,
* and having hearing and speech problems.

Criteria for terminating the research process;

* wanting to leave the research process,
* meeting one of the criteria for exclusion from the sample after the surgery,
* spending the home care and follow-up process in another province, and/or not being able to reach the individual.

Primary outcomes:
measure: Self-Care Agency Scale (SCAS) Mean Score
timeFrame: An average of 6 month: preoperative assessment before surgery at hospital (Time 1), after surgery 1st month at home (Time 2) after surgery 3rd month at home (Time 3) and after surgery 6th month at home (Time 4).
measure: MD Anderson Symptom Inventory Brain Tumor-Turkish Form (MDA-BTSETr ) Mean Score
timeFrame: An average of 6 month: preoperative assessment before surgery at hospital (Time 1), after surgery 1st month at home (Time 2) after surgery 3rd month at home (Time 3) and after surgery 6th month at home (Time 4).
measure: Caregiver Burden Scale (CBS) Mean Score
timeFrame: An average of 6 month: preoperative assessment before surgery at hospital (Time 1), after surgery 1st month at home (Time 2) after surgery 3rd month at home (Time 3) and after surgery 6th month at home (Time 4).
Secondary outcomes:
measure: Karnofsky Performance Scale (KPS) Mean Score
timeFrame: An average of 6 month: preoperative assessment before surgery at hospital (Time 1), after surgery 1st month at home (Time 2) after surgery 3rd month at home (Time 3) and after surgery 6th month at home (Time 4).
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Faculty of Health Science
state: Eyalet/Yerleşke
Study officials:
affiliation: TC Erciyes Universty
name: Derya Dağdelen, PhD
role: PRINCIPAL_INVESTIGATOR
References: