Effect of Individualized Nursing Care for Parents of Pediatric Oncology Patients

NCT05191641 | Unknown

• 1 other identifier: AkdnzUnvrsty
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

Objective: This study was planned to evaluate the effectiveness of individualized nursing care based on the Professional Values Model for parents of pediatric oncology patients. Method: Simple randomization will be used to evaluate the intervention and control groups. The sample of the study will be the parents of children aged 1-18 years (Intervention group: 35 parents, Control group: 35 parents) diagnosed with cancer in the Akdeniz University Hospital Pediatrics, Hematology and Oncology clinic and hospitalized. Portrait Values Questionnaire and PedsQL Health Care Satisfaction Hematology/Oncology Module Parent Form will be used to collect data. A 12-week individualized nursing care based on the Professional Values Model will be applied to 35 parents in the intervention group. The effectiveness of the program will be evaluated after all post-test applications are completed.

Conditions

Parents; Oncology

Keywords

child; parent; oncology; nurse; education; model

Outcome Measures

Primary Outcomes (2)

• Individual values awareness level

  An increase in parents' awareness of their individual values is a measure of outcome. This increase will be measured by the "Portrait Values Questionnaire". The higher the average score, the higher the awareness of individual values. Statistical significance will be set at p \< 0.05. One week after the "pre-test" for the intervention group, an "intermediate evaluation" will be made with the same measurement tool. In the interim evaluation, it will be evaluated whether there is an increase according to the pre-test score. 12 weeks after the "Portrait Values Questionnaire" and the "pretest", the same group will be given a "posttest" with the same measurement tool. In the post-test, it will be evaluated whether there is an increase in the mid-test and pre-test scores. If there is an increase in both "interim evaluation" and "post-test" scores compared to the "pretest" scores, it can be stated that the training program is effective on individual values.

  Individual values awareness level of parent will be evaluated 3 times: pre-test, 1 week after the pre-test, and 12 weeks after the pre-test. The increase in both the mid-term and post-test scores in the 12-week period is the outcome measure.

• Parent satisfaction level

  The increase in the level of awareness of the satisfaction level of the parents is a measure of outcome. This increase will be measured by the "Pediatric Quality of Life Inventory Health Care Satisfaction Hematology/Oncology Module Parents Form". The higher the average score, the higher the parent satisfaction. Statistical significance will be set at p \< 0.05. One week after the "pre-test" for the intervention group, an "intermediate evaluation" will be made with the same measurement tool. In the interim evaluation, it will be evaluated whether there is an increase according to the pre-test score. 12 weeks after the "pretest", the same group will be given a "posttest". In the post-test, it will be evaluated whether there is an increase in the mid-test and pre-test scores. If there is an increase in both "interim evaluation" and "post-test" scores compared to the "pretest" scores, it can be stated that the training program is effective on parent satisfaction.

  Parent satisfaction level will be evaluated 3 times: pre-test, 1 week after the pre-test, and 12 weeks after the pre-test. The increase in both the mid-term and post-test scores in the 12-week period is the outcome measure.

Study Arms (2)

İntervention group

EXPERIMENTAL

PVQ and PedsQL will be used to collect research data. The same measurement tools will be used in the collection of pre-test, mid-term and post-test data. After obtaining the necessary written and verbal permissions from the parents in the intervention group included in the research, 12-week individualized nursing care will be applied. It is planned to make three measurements, namely pre-test, interim evaluation and post-test, from the parents in the intervention groups. 12 Weeks of Individualized Nursing Care * 5 individual interviews * A interview after 2 weeks * Telephone consultation

Other: Individualized nursing care

Control group

NO INTERVENTION

Pre-test (PVQ and PedsQL) will be applied after obtaining informed consent from the parents included in the control group after randomization. In the pre-test application, an interim evaluation (PVQ and PedsQL) will be applied to the control group 1 week after and the post-test (PVQ and PedsQL) will be applied 4 weeks later. After the post-test application is completed, a five-day individual interview will be applied to the parents included in the control group.

Interventions

Individualized nursing care OTHER

Individualized nursing care based on the Professional Values Model for parents of pediatric oncology patients

İntervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being the parent of a pediatric oncology patient
• Speak and understand Turkish

You may not qualify if:

• None

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (2)

Akdeniz University

Antalya, 07058, Turkey (Türkiye)

RECRUITING

Akdeniz University

Antalya, 07058, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• 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: 28929939 BACKGROUND

• • Demirutku, K. Sümer, N. Temel değerlerin ölçümü: portre değerler anketinin türkçe uyarlaması. Türk Psikoloji Yazıları, 2010; 13(25), 17-25

  BACKGROUND

• • Kürtüncü Tanır M, Kuğuoğlu S. Pediatrik Yaşam Kalitesi Envanteri (PedsQL) Sağlık Bakım Memnuniyeti Hematoloji/Onkoloji Modülü Ebeveyn Formu Geçerlik-Güvenirliliği. Ankara Sağlık Hizmetleri Dergisi, 2012; 11(2).

  BACKGROUND

• Pai AL, Greenley RN, Lewandowski A, Drotar D, Youngstrom E, Peterson CC. A meta-analytic review of the influence of pediatric cancer on parent and family functioning. J Fam Psychol. 2007 Sep;21(3):407-15. doi: 10.1037/0893-3200.21.3.407.

  PMID: 17874926 BACKGROUND

• • Schwartz, S. H., Melech, G., Lehmann, A., Burgess, S., Harris, M. ve Owens, V. (2001). Extending the cross-cultural validity of the theory of basic human values with a different method of measurement. Journal of Cross- Cultural Psychology, 32, 519-542.

  BACKGROUND

• Harper FW, Peterson AM, Albrecht TL, Taub JW, Phipps S, Penner LA. Satisfaction with support versus size of network: differential effects of social support on psychological distress in parents of pediatric cancer patients. Psychooncology. 2016 May;25(5):551-8. doi: 10.1002/pon.3863. Epub 2015 Jun 17.

  PMID: 27092714 BACKGROUND

• Çiftcioğlu, Ş., & Efe, E. (2017). Validity and Reliability of the Oral Assessment Guide for Children and Young People Receiving Chemotherapy. Turkish Journal of Oncology/Türk Onkoloji Dergisi, 32(4).

  BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Ayla Kaya, PhD

  Akdeniz University Faculty of Nursing

  STUDY DIRECTOR

Central Study Contacts

Ayla Kaya, PhD

CONTACT

+905363210029; aylakaya@akdeniz.edu.tr

Emine Efe, Professor

CONTACT

eefe@akdeniz.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will be blind in evaluating the results. The intervention and control group will be defined as group 1 and group 2 for statistical analysis. Scales will be evaluated by the researcher who cannot be blinded due to the nature of the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Dr.

Model Details: Single-blind randomized controlled study

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: January 13, 2022
• Study Start: July 20, 2023
• Primary Completion: September 14, 2024
• Study Completion: January 15, 2025
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)