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

Study design

This study was a parallel-group randomized controlled trial (ClinicalTrial.gov; registration number: NCT05328739).

Participants

Criteria for patients inclusion in the study were living within the region’s borders, being aged ≥ 18 years old, being diagnosed with PBT (glial or meningeal and grade I–III), having KPS ≥ 50 points, and being able to read and communicate. Patients’ exclusion criteria were diagnosed as having metastatic brain tumor, a pituitary adenoma, having undergone emergency surgery, having a biopsy, and being in grade IV. Caregiver inclusion criteria were age ≥ 18 years, providing primary care for patients, and being able to read and communicate. Criteria for terminating the research process for participants were 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 being unable to reach the individual.

Sample size

G*Power 3.1.9.2 was used to calculate the sample size for this study. A similar study was used to determine the study’s sample [26]. The power of the study was 0.903 at the α = 0.05 level and 0.816 effect size. The study was conducted with 18 patients and 18 caregivers (Fig. 1).

Fig. 1figure 1

The study flowchart according to CONSORT 2010

Randomization

Block randomization was used to balance the sample size between groups over time. A quadruple block structure consisting of six combinations was created. According to this structure created by an independent person from the research, intervention and control groups were generated by specifying which group the registered participant belonged to the researcher conducting the research process. Blinding was provided because patients and caregivers who met the inclusion criteria and agreed to participate in the study did not know which group they would join [27].

Post-surgical home care intervention program

This program comprised the transition home after discharge and the 6-month post-surgical period for patients who underwent surgery for PBT and their caregivers. The program was constructed based on dependent care theory and had three purposes (Table 1). The first was to regulate, protect, and raise self-care agency; the second was to reduce the severity of symptoms and interference by symptoms; and the third was to reduce caregiver burden. In order to ensure the continuity of post-surgical care at home in 6 months, a supportive-developmental nursing system based on the DCT was used. This system, which includes education, counseling, and nursing care, focuses on goals. The content of the training booklet was created by determining the topics related to the postoperative self-care/dependent care demands and the practices that could meet them. The booklet for patients with PBT and their caregivers was prepared based on the literature on home care [17, 25, 26, 28,29,30,31]. The booklet, submitted for expert opinion, was found suitable by experts in the field (W = 0.267; p = 0.230). Nursing care was given to the patient and caregiver in line with the nursing diagnoses determined according to the self-care/dependent care demands of the patients and caregivers who had undergone craniotomy due to PBT [17, 25, 26, 28,29,30].

Table 1 Dependent care theory based on post-surgical home care program for patients with PBT and their caregiversProcedures

Patients and caregivers were recruited at the same time between March 2019 and January 2020 in a tertiary hospital in Türkiye. After the decision for surgery, the patient and caregiver were interviewed and informed about the study, the Informed Voluntary Consent Form-IVCF was filled out, and initial data were collected (preoperative period-T0). Block randomization assigned patients and caregivers to intervention and control groups. Patients and caregivers in the control group received routine care in the hospital until discharge. Three home visits were made to collect the data of patients and caregivers in the first (postoperative period-T1), third (postoperative period-T2), and sixth (postoperative period-T3) months of surgery after discharge, but no intervention was made.

Patients and caregivers in intervention groups received training and a training booklet until patients were discharged. This total time lasted 90–120 min. In order to prepare the patient and caregiver for the transition home, training was provided on the self-care/dependent care demands that may be encountered in the first week at home and how they can be met, where care can be given and necessary environmental arrangements, what to do in emergencies and drug treatment. Two home visits were made within the first month, planned for education, counseling, and nursing care. The first home visit was made the week after discharge (10–18 days after surgery). At this stage, the patient and caregiver were evaluated in their environment, and nursing care was given for the needs and problems determined for the first visit. At the second home visit (30–40 days after surgery), planned and made at the end of the first month, the patient and caregiver were evaluated in their environment, and nursing care was given for the needs and problems determined for the second visit. Then, in the home visits made once in the second, third, and fourth months, the patient and caregiver were evaluated in their environment similarly, and nursing care was given for the needs and problems determined for that visit. No home visits were made between the fourth and sixth months, but telephone counseling was provided when necessary. The last home visit was made for the sixth-month measurements and goodbye to the patient and caregivers. In this process, nursing care was given to the patient and caregiver per the nursing diagnoses determined according to patients’ and caregivers’ self-care/dependent care demands.

Measurements

Self-care was measured using the Self-Care Agency Scale (SCAS) [32], and the severity of symptoms in patients with PBT and the life-threatening condition of patients were measured using the MD Anderson Symptom Inventory Brain Tumor-Turkish Form (MDA-BTSETr) [33]. Caregiver burden was measured using the Caregiver Burden Scale (CBS) [34]. These measurement tools are valid and reliable tools suitable for Turkish society. Cronbach’s alpha value of the measurement tools in this study was acceptable, at 0.94 in patients and 0.91 in caregivers for SCAS; 0.85 and 0.88 for MDA-BTSETr and CBS, respectively. The Karnofsky Performance Scale (KPS) [35] allows the evaluation of the patients’ individual and medical care needs to obtain information about symptom severity and level of function at work and home.

Statistical analysis

IBM SPSS 26 was used for statistical analyses. Descriptive statistics are given as number of units (n), percentage (%), and mean ± standard deviation. The normal distribution of the data of numerical variables was evaluated with the Shapiro–Wilk test of normality and Q-Q graphs. Homogeneity of variances was evaluated with the Levene test, and two-way analysis of variance was used in repeated measurements from general linear models in comparison of scale scores between T0, T1, T2, and T3 between groups and within groups. Bonferroni correction was applied when comparing the main effects. Comparisons between categorical variables and groups were evaluated with Fisher’s exact test in 2 × 2 and r × c tables [36], p < 0.05 value was considered statistically significant.

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