The Effect of Mobile-Based Education Given to Patients Undergoing Gynecological Oncology Surgery on Quality of Life

NCT ID: NCT05694208

Last Updated: 2024-11-15

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

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-01-01

Brief Summary

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This study was planned in a randomized controlled prospective experimental design in order to determine the effect of mobile-based education given to patients undergoing gynecological oncology surgery on quality of life.

Research Hypotheses:

H1. Education given with mobile application in gynecological oncology patients positively affects symptom control of patients.

H2. The education given with the mobile application in gynecological oncology patients positively affects the quality of life of the patients.

Detailed Description

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Power analysis was conducted to determine the number of people to be included in the study. The power of the test was calculated with the G\*Power 3.1 program. As a result of the power analysis, the sample size should be 50, 25 experimental and 25 control groups, at 95% power, 5% significance level, and 0.690 effect size (df=24; t=1,710). In the research, it was aimed to reach a total of 70 women, 35 people in each group, considering the high power of the test and the losses.

Introductory Information Form, Symptom Evaluation Form, Functional Assessment of Cancer Therapy-General (FACT-G) and Turkish-Computer System Usability Questionnaire (T-CSUQ- SV) planned to be used as data collection tools in the study.

The women included in the study sample will be divided into two groups as experimental and control groups according to randomization. Experimental group; the group to be trained. control group; This is the group in which no attempt will be made other than data collection.

Statistical Analysis of Data: The data obtained in the research will be analyzed using SPSS (Statistical Package for Social Sciences) for Windows 25.0 program. Homogeneity of descriptive features between groups will be tested by chi-square analysis and independent group t-test. The differentiation status of the scales between the groups will be analyzed with the independent group t-test and the changes within the group will be analyzed with the repeated measures ANOVA test.

Conditions

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Gynecologic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The women included in the study sample will be divided into two groups as experimental and control groups according to randomization. Experimental group; the group to be trained. control group; This is the group in which no attempt will be made other than data collection.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental group

The patients in the experimental group will use the mobile-based care support application developed within the scope of the research.

Group Type EXPERIMENTAL

Education Group

Intervention Type BEHAVIORAL

In the first pre-operative interview at the gynecological oncology outpatient clinic of the relevant hospital, the purpose of the research will be explained to the patients and an informed consent form will be filled. The patients in the experimental group will use the mobile-based care support application developed within the scope of the research.

Control Group

It is the group in which no intervention will be made other than data collection.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Education Group

In the first pre-operative interview at the gynecological oncology outpatient clinic of the relevant hospital, the purpose of the research will be explained to the patients and an informed consent form will be filled. The patients in the experimental group will use the mobile-based care support application developed within the scope of the research.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Be over 18 years old
* Able to speak, read and understand Turkish
* Being scheduled for surgery due to a diagnosis of gynecological cancer
* Having internet access
* Using a smartphone

Exclusion Criteria

\- Having a diagnosis of active psychiatric illness
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Çisem Baştarcan

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Çisem Baştarcan

Role: PRINCIPAL_INVESTIGATOR

PhD student

Locations

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Istanbul University-Cerrahpasa

Avcılar, Istanbul, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Çisem Baştarcan

Role: CONTACT

+90 (539) 399 4032

Cisem Bastarcan

Role: CONTACT

+90 (539) 399 4032

Facility Contacts

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Çisem Baştarcan

Role: primary

Other Identifiers

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CBastarcan

Identifier Type: -

Identifier Source: org_study_id

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