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

NCT ID: NCT05328739

Last Updated: 2022-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-06

Study Completion Date

2020-07-30

Brief Summary

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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

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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.

Conditions

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Primary Brain Tumor Caregiver Burden Self Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Home care group

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.

Group Type EXPERIMENTAL

home care

Intervention Type OTHER

home care program

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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home care

home care program

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.


* 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

* 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.


* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Derya Dağdelen

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Derya Dağdelen, PhD

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes Universty

Locations

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Erciyes University Faculty of Health Science

Kayseri, Eyalet/Yerleşke, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 38635060 (View on PubMed)

Other Identifiers

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2019/179

Identifier Type: -

Identifier Source: org_study_id

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