The Effect of Discharge Education Based on Roy Adaptation Model on Palliative Care Patients and Caregivers

NCT ID: NCT05840393

Last Updated: 2023-05-03

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-02-28

Brief Summary

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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

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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.

Conditions

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Nurse's Role Nutritional Deficiency Adaptation Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention Group: Discharge training based on the Roy adaptation model

Oncologic palliative care patients and caregivers in this group will receive discharge training based on the Roy adaptation model.

Group Type EXPERIMENTAL

Discharge training based on Roy adaptation model

Intervention Type OTHER

The Roy Adaptation Model consists of four main areas of adaptation. In this study, the content of the discharge education given within the scope of the adaptation areas of the Roy Adaptation Model will be continued with information such as home nutrition process, pain, anxiety, fear, stress and coping methods, addressing changing roles and responsibilities, communication, problem solving and utilizing social support. A booklet will be prepared to increase the effectiveness of discharge training based on the Roy Adaptation Model and the booklet will be used as a guide in the training program.

Control Group: Standard discharge training

Oncologic palliative care patients and caregivers in this group will not receive any training other than the discharge training routinely applied in the clinic.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Discharge training based on Roy adaptation model

The Roy Adaptation Model consists of four main areas of adaptation. In this study, the content of the discharge education given within the scope of the adaptation areas of the Roy Adaptation Model will be continued with information such as home nutrition process, pain, anxiety, fear, stress and coping methods, addressing changing roles and responsibilities, communication, problem solving and utilizing social support. A booklet will be prepared to increase the effectiveness of discharge training based on the Roy Adaptation Model and the booklet will be used as a guide in the training program.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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ELİF TUĞBA UYGUN

Principal Investigator Phd candidate of nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aylin ÖZAKGÜL

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Central Contacts

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ELİF TUĞBA UYGUN

Role: CONTACT

+90 539 505 26 37

References

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Reference Type BACKGROUND
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Fitch MI, Fliedner MC, O'Connor M. Nursing perspectives on palliative care 2015. Ann Palliat Med. 2015 Jul;4(3):150-5. doi: 10.3978/j.issn.2224-5820.2015.07.04.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Guzelant A, Goksel T, Ozkok S, Tasbakan S, Aysan T, Bottomley A. The European Organization for Research and Treatment of Cancer QLQ-C30: an examination into the cultural validity and reliability of the Turkish version of the EORTC QLQ-C30. Eur J Cancer Care (Engl). 2004 May;13(2):135-44. doi: 10.1111/j.1365-2354.2003.00435.x.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Other Identifiers

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EUYGUN

Identifier Type: -

Identifier Source: org_study_id

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