The Effect of Palliative Care And Training On The Quality of Life of Terminal Stage Cancer Patients And Their Caregivers

Purpose The study aims to determine the effect of palliative care and training provided to caregivers of hospitalized patients with terminal cancer theoretically, practically and visually on their own and patients’ quality of life. Methods This quasi-experimental study was conducted at a palliative care unit in Turkey between January and June 2019. The study included 35 hospitalized patients with cancer and 35 caregivers. Caregivers were provided with palliative care and training three times a week apart. The data were analyzed using descriptive statistics, Kolmogorov-Smirnov test, Friedman test and iterative analysis of variance. Results After the palliative care and training, there was an increase in cancer patients’ emotional function sub-scale and global health and decrease in their fatigue and nausea-vomiting symptoms (p<0.05). The mean scores of caregivers from role diculty, pain, vitality, social function, emotional and mental health sub-scales were high (positively) (p<0.001). Conclusions Palliative care and training have a positive effect on caregiver burden and recovery in some quality of life sub-scales of both patients and caregivers.


Intervention and Data Collection
The women hospitalized in palliative care by diagnosis of cancer and their caregivers were informed about training content prior to the intervention. The study included women with cancer and their primary caregivers who agreed to participate. Three days after the rst meeting with participants the data collection tools were administered and the rst training was provided. The researcher provided the rst training to caregivers theoretically, practically and visually. A week after the rst training, the data collection tools were repeated and the second training was provided. The researcher provided the second training theoretically and practically with caregivers. The data collection tools were repeated one week after the second training. The third training was provided after the data collection tools. This training evaluated knowledge and skills of caregivers. The training manual, prepared at this stage, was given to caregivers. The data collection tools were repeated one week after the third training. In total, the training was provided three times (Fig. 1). Trainings took at least 45 minutes one week apart. Since 39.3% of the cancer patients under palliative care deceased within three weeks, a week after the third training was the most appropriate time for evaluating e ciency of the training [14]. The data were collected using data collection tools and through face-to-face interview with the participants in all stages of intervention. Each data collection took 40 to 45 minutes.

Training Manual
Palliative care protocol forms basis for individualized care and depends on patients [15]. In this sense, educational planning was made for caregivers considering palliative care protocol. The training manual was prepared with reference to World Health Organization (WHO) [16] and The National Institute for Health and Care Excellence (NICE) [17] palliative care guidelines and NANDA International Nursing Diagnosis book [18] regarding the problems identi ed in the care of cancer patients in line with the literature [6,19,20]. The manual consists of 6 headings, which were general body care, nutrition, physical exercise, psychological support, medication and symptom control. Content and textual sharpness of training manual was evaluated by four experts, including an oncologist and three nurses. The A5 format training manual is colored with 42 pages.
It contains pictures to answer the question "how it is made?" for caregivers. Caregivers were allowed to ask questions frequently. Every heading in the manual, starting with evaluation of caregivers' and patients' knowledge and needs, was personalized for both within discussion and training palliative care protocol. Although the manual was standard, the information shared was speci c to patients' and caregivers' needs. The researcher had a master's degree in obstetrics and gynecology with 8 years of experience in palliative care service.

Measures
The data collection tools included ve sections as indicated below according to the goals and dependent variables.

Questionnaire Form
A questionnaire form was used for the patients and a questionnaire form for caregivers [13,21,22]. The questionnaire forms were formed by the researchers with support from the literature. The form included some socio-demographic attributes of patients and caregivers, disease characteristics, and caregivers' duration of care, and 10 questions in total to determine caregivers' burden.

EORTC QLQ-C30
This scale, developed by Aaronson et al., consists of 30 items in total [23]. It incorporates ve functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), and a global health and a QoL scale. The rst 28 items are scaled on four-point Likert scale, while the last two items (29,30) were scored from 1 to 7 points. A higher score from the last two items and functional area showed high QoL, whereas a higher score from symptom control showed low QoL. Turkish validity and reliability study of the scale was conducted by Beser and Öz and Cronbach's alpha value was 0.90 [24]. This value was found 0.89 in the current study.

Short-Form Health Survey (SF-36)
This scale, developed by Ware and Sherbourne consists of 36 items [25]. The scale consists of eight subscales (physical functioning, role physical, energy/fatigue, bodily pain, general health perceptions, social functioning, role emotional and mental health) and two main dimensions (physical and mental). The higher the score obtained from the scale and its subscales is, the higher the quality of life is. Turkish validity and reliability study of the scale was made by Koçyiğit et al. and Cronbach's alpha was 0.73-0.76 for each sub-scale [26]. This value was found to be 0.89 in the present study.

Beck Anxiety Inventory (BAI)
This scale, developed by Beck et al. to measure frequency of anxiety symptoms, consists of 21 items [27].
Each item is scored between 0 and 3. A higher score from the scale shows higher anxiety in individuals. Turkish validity and reliability study of the scale was conducted by Ulusoy et al. and Cronbach's alpha value was 0.93 [28]. This value was found to be 0.88-0.89 in the current study.

Caregiver Burden Inventory (CBI)
This is a 24-item scale developed by Novak and Guest to measure the effect of caregiving on caregivers [29]. The inventory has ve sub-scales (time-addiction burden, developmental burden, physical burden, social burden and emotional burden). The scores from the inventory range from 0 to 100. A higher score from the inventory refers to higher burden and lower score shows less burden on caregivers. Turkish validity and reliability study of the scale was conducted by Küçükgüçlü and Cronbach's alpha value was 0.94 [30]. This value was found to be 0.92 in the current study.

Data Analysis
The study's power was calculated using G-Power 3.0 software. The data were analyzed using IBM SPSS 24 software. Descriptive data were shown as number, percentage, mean and standard deviation. Conformity of scale scores to normal distribution was analyzed using Kolmogorov Smirnov test. Whether the normally distributed data differed by evaluations was analyzed using the repeated analysis of variance, and comparison of the data that did not conform to normal distribution was analyzed using the Friedman test. The mean was given as ± standard deviation for normally distributed quantitative data, and the median (min-max) for non-normally distributed data. Based on the results, the con dence interval was 95% and signi cance level was taken as p<0.05. Table 1 shows some socio-demographic and disease process characteristics of patients and some sociodemographic and care process characteristics of caregivers. Mean age of the cancer patients was 69.6 ± 15, about half of them (48.6%) were married and most were illiterate (57.1%). Most of the patients were diagnosed with cancer at the fourth-stage (68.6%) 7-12 months ago (42.9%) and the cancer type was found to be mostly gastrointestinal system cancer (25.7%)On the other hand, 82.9% of the primary caregivers were female with mean age of 40.06 ± 12.26, 42.9% were high-school graduates and 68.6% were married. Of the caregivers, 57.1% have been providing care for less than 12 months.  Table 2 shows mean score comparison of cancer patients from EORTC QLQ-C30 and BAI pre-and postpalliative care and training. After the palliative care and training, there was an increase in patients' emotional function sub-scale and global health and decrease in their fatigue and nausea-vomiting symptoms (p < 0.005). Whereas patients' anxiety level was mild pre-training (8-15 points), it turned to be minimum post-training (0-7 points) (p < 0.001).

Discussion
The cancer affects negatively the patient's QoL with secondary problems such as pain, nausea-vomiting, fatigue, insomnia and malnourishment [31]. QoL is deemed an important result criterion in cancer research and treatment [32]. With this study, we aimed to determine the effect of palliative care and training provided to caregivers on the cancer patient's QoL. After the palliative care and training provided to caregivers in line with the study results, there was an increase in cancer patients' emotional function sub-scale and global health and decrease in their fatigue and nausea-vomiting symptoms. Kristanti et al. [13] stated that basic skills training provided to caregivers had a positive effect on some sub-scales of cancer patients' QoL (global health, emotional function, social function, fatigue, pain, dyspnea, insomnia, loss of appetite, constipation and nancial di culties). Belgacem et al. [21] reported that the training program (feeding support, nursing care, care support and management of symptom) aiming to decrease caregivers' burden positively affected patients' QoL. This result supported the study by Maltoni et al. [33] who stated that the systematic review of a small number of trials indicated early palliative care interventions to possibly have more bene cial effects on QoL and symptoms intensity among patients with advanced cancer than those provided merely standard cancer care. Also, whereas anxiety of patients was mild prior to palliative care and training in this study, they had minimum anxiety post-training. Hence, recovery in their anxiety levels indicated the e ciency of training. Similarly, Mohabbat-Bahar et al. [34] reported in their experimental study with breast cancer patients that there was a signi cant difference between mean scores of anxiety pre-and post-training. Cancer patients with anxiety have lower QoL [35].
Therefore, palliative care and training provided to caregivers have a positive effect on patients' QoL, so positively affect their anxiety levels. In this regard, all health care professionals should provide the appropriate training and care to patients. Precautions should be improved for better QoL and effective management of symptoms.
Long stay of caregivers at hospital during palliative care causes emotional problems such as role change and di culty adapting to changing roles, anxiety, depression, mourning, distress, burnout, despair, and social isolation and negatively affects their QoL. The studies conducted indicate that general well-being of caregivers deteriorates due to caregiving, caregiving burden is tough and as care burden increases, QoL decreases [5,6,36,37]. Therefore, performing timely interventions is important for caregivers. In this study, our second goal was to determine the effect of palliative care and training provided to caregivers on their QoL. The results showed that there were improvements in the caregivers' role di culty, pain, vitality, social function, emotional and mental health at the end of palliative care and training. Also, caregiving burden of caregivers was high in the rst evaluation and there was a signi cant decrease in the developmental and physical burden sub-scale only post-training. Similarly, Uğur and Fadıloğlu [10] reported that palliative care training provided to caregivers of cancer patients decreased their perceived care burden. Lee et al. [38] indicated that an integrated caregiver support program including coping strategies, support, resources and education (CARE) was reported to decrease caregiver burden and to increase self-e cacy of caregivers within 3 months before the death of patients with advanced cancer.
The results of similar studies on caregivers' QoL and care burden also showed that interventions (psychoeducation, skills training, psychosocial intervention, individualized education, palliative care counseling, etc.) could promote coping behaviors and self-e cacy (i.e., perceived con dence, readiness, and/or skills to provide care) [39][40][41] and increase their stress coping skills [42], decrease care burden [11,21,43] and make improvements in some sub-skills of QoL [21,42,43]. Therefore, the study results show that health care professionals should contribute to increasing QoL of caregivers of cancer patients and decrease their care burden. Nurses should evaluate family members who provide care to terminal stage patients holistically, should support them in the decision-making process, in performing spiritual and cultural practices, in self-care and in adapting to the disease with an empathetic and affectionate approach [44].

Limitations
As the study design used a non-randomized design, the strength of the study is limited. Another limitation is that the study does not include psychiatric morbidity related to caregivers and which is deemed a possible factor affecting proliferation of care burden and QoL of caregivers. Furthermore, palliative care and training were evaluated in the hospital environment only since patients' hospitalization was ongoing.
A strength of the study is, however, there was no similar study mentioning the patients and caregivers' QoL, anxiety and caregiver burden levels of palliative care and training.

Conclusion
The results of our interventions were positive; providing palliative care and training to caregivers of cancer patients decreased their burden; and it positively affected QoL of both caregivers and the patients. Care burden of caregivers was found to be high, but it decreased post-training, though not signi cant.
Thus, it can be promoted through palliative care and training to be provided to caregivers. Palliative care and training should be initiated when the patient is diagnosed, and the effectiveness of the training should be evaluated by making home visits to increase the QoL, reduce the burden of caregivers and increase the care quality given to patients. Figure 1 Time line and intervention details