Clinical trial NCT05840393: The Effect of Discharge Education Based on Roy Adaptation Model on Palliative Care Patients and Caregivers
Official title: The Effect of Roy Adaptation Model-Based Discharge Training on Quality of Life and Adaptation of Palliative Care Patients and Caregivers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nurse's Role
Nutritional Deficiency
Adaptation Reaction
Keywords: Discharge training
Nutrition
Quality of life
Adaptation
Palliative care
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research will be carried out in order to reveal how the discharge education that will be formed in line with the Roy Adaptation Model for oncological palliative care patients and caregivers will affect the nutritional outcomes, quality of life and adaptation difficulties of the patients, coping and adaptation processes of caregivers, their quality of life and their level of knowledge about nutritional care.

Detailed description: Today, with the improvement of living conditions and the development of technology in the field of medicine, life expectancy and the elderly population are increasing every day. This situation leads to an increase in the number of individuals with chronic diseases and increases the need for palliative care services day by day.

In palliative care; meeting the needs of patients, families and caregivers, ensuring an increase in the quality of life by supporting patients physically, psychologically, socially and spiritually in the last period of their lives, and providing care according to the needs of the individual and family / caregivers in the process of death and mourning. Patients in need of palliative care face many problems such as pain, nausea, vomiting, fatigue, depression, dyspnea, dehydration, constipation, weakness, fatigue, delirium, disorientation and malnutrition that develop due to the disease and reduce the quality of life. In the care of palliative patients, caregivers play an important role in symptom control and helping the patient to maintain life activities, especially nutrition.İnforming healthy/patient individuals and their families/caregivers about healthy lifestyle changes is within the scope of the nurse's educational and counseling roles. In the palliative care process, it is stated that the lack of discharge training on nutrition may lead to significant problems.Nurses need to benefit from theories and models while applying qualified nursing care to the individual, family or community, managing the health of the people to whom they apply nursing care, supporting them to adapt to the new process they live in, and explaining the data they obtain in a scientific sense.

In this direction, in this study, the effect of the discharge training to be created in line with the Roy Adaptation Model, one of the nursing models, on oncological palliative care patients with malnutrition and receiving nutritional support and their caregivers will be revealed.

This research will be conducted in a prospective, randomized experimental design with pretest-posttest experimental and control groups. The sample size of the study will consist of oncological palliative care patients and caregivers who meet the inclusion criteria and agree to participate in the study. The patients and caregivers to be included in the sample of the study will be randomly divided into two groups as experimental and control groups.

The sample size of the study was calculated by power analysis. The power of the study was determined as 42 oncological palliative care patients and caregivers (minimum n=21 patients and caregivers for each group) as a result of the analysis performed according to the data of a referenced study (taking the effect size as 0.9, 80% power value and 0.05% margin of error and confidence interval). In order to increase the reliability of the study and to be able to apply parametric tests, the total sample size was determined as n:60, including 30 oncological palliative care patients and caregivers of the experimental group and 30 oncological palliative care patients and caregivers of the control group, taking into account data losses (dropout from the study, death, etc.). Randomization in the study will be provided by using the randomization method in simple random order. Patients were randomly selected to the experimental and control groups. The data will be evaluated with the SPSS (Statistical Package of SocialSciences) 24.0 package program.

Data; Descriptive Information Form Specific to Oncologic Palliative Care Patients, Nutritional Risk Screening Test-2002 (NRS-2002), EORTC QLQ-C30 Quality of Life Scale, Scale for Assessing Difficulties of Adaptation in the Elderly, Nutritional Follow-up Form, Telephone Counseling Follow-up Form, Descriptive Information Form Specific to Caregivers of Oncologic Palliative Care Patients, Coping and Adaptation Process Scale, World Health Organization Quality of Life Scale (WHOQOL-BREF-TR), Information Form Including Opinions on Nutritional Care will be collected.

Eligibility criteria: Inclusion Criteria:

* 65 years of age or older,
* Receiving inpatient treatment in a palliative care clinic for an existing oncological disease,
* To be discharged home after the end of palliative care treatment,
* Continuing home nutritional support (Percutaneous Endoscopic Gastrostomy/PEG) during hospitalization and after discharge,
* NRS-2002 malnutrition risk score of 3 and above during hospitalization (data to be obtained from the patient file),
* To have the ability to understand and speak Turkish,
* To be able to communicate by phone,
* No disability in terms of state of consciousness and sensory organs,
* Volunteering to participate in the research.

Exclusion Criteria:

* Patients who do not meet the inclusion criteria, patients who die or whose condition worsens during the research process, and patients who do not volunteer to participate in the research and their caregivers will be excluded from the study.

Primary outcomes:
measure: Quality of Life Scale
timeFrame: Pre-discharge and 3-month post-discharge follow-up of the patients
measure: Compliance Scale
timeFrame: Pre-discharge and 3-month post-discharge follow-up of the patients
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Aylin ÖZAKGÜL
role: STUDY_DIRECTOR
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