Orem's Self-Care Deficit Theory Based Nursing Interventions for Immunotherapy Treated Cancer Patients

NCT ID: NCT05652764

Last Updated: 2024-06-10

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

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Nurse's Role Treatment Side Effects Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized controlled trial consisting of two groups: experimental and control.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Immuno-SelfCare

Group Type EXPERIMENTAL

Orem's Self-Care Deficit Theory Based Nursing Interventions for Immunotherapy Treated Cancer Patients

Intervention Type OTHER

In this study, face-to-face patient education, giving patient education booklet, preparation of symptom management card, face-to-face and telephone counseling initiatives were planned to the experimental group.

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Orem's Self-Care Deficit Theory Based Nursing Interventions for Immunotherapy Treated Cancer Patients

In this study, face-to-face patient education, giving patient education booklet, preparation of symptom management card, face-to-face and telephone counseling initiatives were planned to the experimental group.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Mevlüde Ergen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatma Arikan

Role: STUDY_DIRECTOR

Akdeniz University

Locations

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Akdeniz University

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KAEK- 685

Identifier Type: -

Identifier Source: org_study_id

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