Clinical trial NCT05652764: Orem's Self-Care Deficit Theory Based Nursing Interventions for Immunotherapy Treated Cancer Patients
Official title: The Effect of Orem's Self-Care Deficit Theory Based Nursing Interventions on Symptom Management, Care Needs and The Quality of Life of Immunotherapy Treated Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Nurse's Role
Treatment Side Effects
Quality of Life
Keywords: Cancer Immunotherapy
Treatment Side Effects
Symptom Management
Self-Care Deficiency
Care Needs
Oncology Nursing
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial consisting of two groups: experimental and control.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective: The aim of this study was to determine the effects of nursing interventions based on Orem Self-Care Deficiency Theory on symptom management, care needs and quality of life in cancer patients who underwent immunotherapy.

Method: The research was planned as a randomized controlled trial. The research is planned to be carried out in the Medical Oncology unit of the Health Sciences University Antalya Training and Research Hospital. It is planned to be done with 58 patients, 29 experimental and 29 control groups. Based on Orem Self-Care Deficit Theory; face-to-face patient education, giving patient education booklet, preparation of symptom management card, face-to-face and telephone counseling initiatives were planned. Patient Description Form, Supportive Care Needs Scale-Short Form, Memorial Symptom Assessment Scale, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scale and Self-Care Strength Scale will be used to collect data.


Eligibility criteria: Inclusion Criteria:

* Coming to Antalya Training and Research Hospital Medical Oncology unit for treatment,
* First time taking one of the immune checkpoint inhibitors (Ipilimumab CTLA-4, Pembrolizumab PD-1, Nivolumab PD-1, Atezolizumab PDL-1),
* Speaking and understanding Turkish,
* Being literate,
* 18 Years and older
* With solid tumor,
* No communication barrier
* Being able to communicate by phone
* Individuals who agree to participate in the research.

Exclusion Criteria:

* Patients receiving other cancer treatments in combination with immunotherapy,
* Patients with Eastern Cooperative Oncology Group Performance Scale 4.

Primary outcomes:
measure: Change from Baseline in Symptom on the Memorial Symptom Assessment Scale at week 12
timeFrame: Baseline and 12th week
measure: Change from Baseline in Supportive Care Needs on the Supportive Care Needs Scale-Short Form at week 12
timeFrame: Baseline and 12th week
measure: Change from Baseline in Self-Care Strength on the Self-Care Strength Scale at week 12
timeFrame: Baseline and 12th week
measure: Change from Baseline in Quality of Life Level on the EORTC QLQ-C30 Quality of Life Scale(European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) at week 12
timeFrame: Baseline and 12th week
measure: Change from Baseline in Adverse Events on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for 12 weeks
timeFrame: Baseline,for 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
affiliation: Akdeniz University
name: Fatma Arikan
role: STUDY_DIRECTOR
References: