The Effect of Home Care Planned According to Orem in Patients With Primary Brain Tumor and Their Caregivers

NCT05328739 | Completed

• 1 other identifier: 2019/179
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Brain Tumor; Caregiver Burden; Self Care

Keywords

caregiver burden; primary brain tumor; home care; self care agency

Outcome Measures

Primary Outcomes (3)

• Self-Care Agency Scale (SCAS) Mean Score

  SCAS: in order to evaluate the self-care agency of patients and caregiver each measurement was performed before the intervention at the time. The lowest score is 35, the highest score is 140. The highest score shows the greatest degree of self-care agency.Change= 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).

  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).

• MD Anderson Symptom Inventory Brain Tumor-Turkish Form (MDA-BTSETr ) Mean Score

  MDA-BTSETr: in order to evaluate the symptoms and the impact of the symptoms on the lives of patients, each measurement was performed before the intervention at the time. The inventory consists of two parts that evaluate the symptoms and the interference of the individual's life. In the first part of the inventory, individuals are asked to rate the severity of each symptom in the last 24 hours between 0-10 (0: no symptom, 10: the most severe level of the symptom experienced). In the second part, individuals are asked to rate how much their symptoms interfere with their lives, from 0 to 10 (0: not interfered, 10: completely interfered).Change= 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).

  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).

• Caregiver Burden Scale (CBS) Mean Score

  CBS: in order to evaluate the care burden of individuals who care for patients who have undergone primary brain tumor surgery, each measurement was performed before the intervention at the time. The lowest score that can be obtained from the scale is 0, the highest score is 88, and an increasing score indicates an increase in the burden of care.Change= 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).

  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 (1)

• Karnofsky Performance Scale (KPS) Mean Score

  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).

Study Arms (2)

Home care group

EXPERIMENTAL

The home care program included education, counseling and nursing care to determine and meet the self-care/dependant care needs of patients and caregivers at home after brain surgery. At preoperative period (PRP) an average of 90-120 minutes of training was given to both the patient and the caregiver until the patient was discharged. At this stage, the training was carried out in order to prepare the patient and caregiver for the transition to home. At postoperative period (POP) two home visits were made within the first month following the discharge, planned for education, counseling and nursing care. The first home visit was made in the first week after discharge (10-18 days after surgery), and the second home visit was made 30-40 days after surgery. Then, in the home visits made once in the 2nd, 3rd and 4th months.No home visits were made between the 4th-month attempt and the 6th month, but telephone counseling was provided when necessary. Home visits ranged from 60 to 120 minutes.

Other: home care

Control group

NO INTERVENTION

The patient received routine care in the hospital until discharge. Three home visits were made to collect the data of patients and caregivers in the 1st and 3rd and 6th months of POP after discharge, but no intervention was made. The visits took about 30-45 minutes.

Interventions

home care OTHER

home care program

Home care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• spending the home care and follow-up process in another province, and/or not being able to reach the individual.
• 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.
• being under the age of 18,

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Faculty of Health Science

Kayseri, Eyalet/Yerleşke, 38260, Turkey (Türkiye)

Location

Related Publications (1)

• Dagdelen D, Zincir H. Effects of dependent care theory-based post-surgical home care intervention on self-care, symptoms, and caregiver burden in patients with primary brain tumor and their caregivers: a randomized controlled trial. Support Care Cancer. 2024 Apr 18;32(5):296. doi: 10.1007/s00520-024-08488-1.

  PMID: 38635060 DERIVED

MeSH Terms

Conditions

Brain Neoplasms; Caregiver Burden

Interventions

Home Care Services

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Community Health Services; Health Services; Health Care Facilities Workforce and Services; Nursing Services

Study Officials

• Derya Dağdelen, PhD

  TC Erciyes Universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 6, 2021
• First Posted: April 14, 2022
• Study Start: March 6, 2019
• Primary Completion: March 6, 2019
• Study Completion: July 30, 2020
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

TU (1)