NCT05840393

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

March 29, 2023

Last Update Submit

April 22, 2023

Conditions

Keywords

Discharge trainingNutritionQuality of lifeAdaptationPalliative care

Outcome Measures

Primary Outcomes (2)

  • Quality of Life Scale

    The quality of life of palliative care patients will be assessed using the EORTC QLQ-C30 Quality of Life Scale (consisting of 30 items, the first 28 of which are four-point Likert-type scales and the items are None: 1, Somewhat: 2, Somewhat: 3 or Very: 4 points. Question 29 asks the patient to rate their health on a scale from 1 to 7 (1: Very poor and 7: Excellent) and question 30 asks the patient to rate their overall quality of life. High scores in this section indicate a high quality of life and low scores indicate a low quality of life.) The World Health Organization Quality of Life Scale (It consists of 26 questions related to physical, mental, environmental, social relations and general health status. Each domain is calculated over 20 points or 100 points. A high score indicates a high quality of life).

    Pre-discharge and 3-month post-discharge follow-up of the patients

  • Compliance Scale

    The adaptation of palliative care patients will be determined using the Difficulty of Adaptation in the Elderly Assessment Scale (a four-point Likert-type scale consisting of 24 items, scored as "not at all, a little, quite, a lot"). As the score obtained from the scale increases, the level of adaptation to old age decreases. The adaptation of caregivers will be determined using the Coping and Adaptation Process Scale. The scale, which is based on the Roy Adaptation Model and the concepts related to the cognitive process it defines and used to determine the coping and adaptation strategies of individuals in critical and difficult situations, is a four-point Likert-type scale consisting of five sub-dimensions and 47 items (each statement is answered "never, rarely, sometimes, always"). As the scores obtained from the scale increase, it is evaluated as the use of effective coping methods and adaptation increases.

    Pre-discharge and 3-month post-discharge follow-up of the patients

Study Arms (2)

Intervention Group: Discharge training based on the Roy adaptation model

EXPERIMENTAL

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

Other: Discharge training based on Roy adaptation model

Control Group: Standard discharge training

NO INTERVENTION

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

Interventions

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 Group: Discharge training based on the Roy adaptation model

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Adelman RD, Tmanova LL, Delgado D, Dion S, Lachs MS. Caregiver burden: a clinical review. JAMA. 2014 Mar 12;311(10):1052-60. doi: 10.1001/jama.2014.304.

    PMID: 24618967BACKGROUND
  • 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.

    PMID: 26231811BACKGROUND
  • Stajduhar KI, Funk L, Cohen SR, Williams A, Bidgood D, Allan D, Norgrove L, Heyland D. Bereaved family members' assessments of the quality of end-of-life care: what is important? J Palliat Care. 2011 Winter;27(4):261-9.

    PMID: 22372280BACKGROUND
  • Starke J, Schneider H, Alteheld B, Stehle P, Meier R. Short-term individual nutritional care as part of routine clinical setting improves outcome and quality of life in malnourished medical patients. Clin Nutr. 2011 Apr;30(2):194-201. doi: 10.1016/j.clnu.2010.07.021.

    PMID: 20937544BACKGROUND
  • Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

    PMID: 8433390BACKGROUND
  • Barker LA, Gout BS, Crowe TC. Hospital malnutrition: prevalence, identification and impact on patients and the healthcare system. Int J Environ Res Public Health. 2011 Feb;8(2):514-27. doi: 10.3390/ijerph8020514. Epub 2011 Feb 16.

    PMID: 21556200BACKGROUND
  • Burgos R, Sarto B, Elio I, Planas M, Forga M, Canton A, Trallero R, Munoz MJ, Perez D, Bonada A, Salo E, Lecha M, Enrich G, Salas-Salvado J; Group for the Study of Malnutrition in Hospitals in Catalonia. Prevalence of malnutrition and its etiological factors in hospitals. Nutr Hosp. 2012 Mar-Apr;27(2):469-76. doi: 10.1590/S0212-16112012000200018.

    PMID: 22732970BACKGROUND
  • Elia M. Defining, Recognizing, and Reporting Malnutrition. Int J Low Extrem Wounds. 2017 Dec;16(4):230-237. doi: 10.1177/1534734617733902. Epub 2017 Nov 16.

    PMID: 29145755BACKGROUND
  • Yoder LH. Using the Roy adaptation model: a program of research in a Military Nursing Research Service. Nurs Sci Q. 2005 Oct;18(4):321-3; discussion 320. doi: 10.1177/0894318405280382. No abstract available.

    PMID: 16294464BACKGROUND
  • 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.

    PMID: 15115469BACKGROUND
  • Kaya A, Boz I. The development of the Professional Values Model in Nursing. Nurs Ethics. 2019 May;26(3):914-923. doi: 10.1177/0969733017730685. Epub 2017 Sep 20.

    PMID: 28929939BACKGROUND
  • Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.

    PMID: 12765673BACKGROUND
  • Lopez-Contreras MJ, Torralba C, Zamora S, Perez-Llamas F. Nutrition and prevalence of undernutrition assessed by different diagnostic criteria in nursing homes for elderly people. J Hum Nutr Diet. 2012 Jun;25(3):239-46. doi: 10.1111/j.1365-277X.2012.01237.x. Epub 2012 Feb 23.

    PMID: 22360373BACKGROUND

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Aylin ÖZAKGÜL

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Central Study Contacts

ELİF TUĞBA UYGUN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Phd candidate of nursing

Study Record Dates

First Submitted

March 29, 2023

First Posted

May 3, 2023

Study Start

June 1, 2023

Primary Completion

December 31, 2023

Study Completion

February 28, 2024

Last Updated

May 3, 2023

Record last verified: 2023-04