Clinical trial NCT05694208: The Effect of Mobile-Based Education Given to Patients Undergoing Gynecological Oncology Surgery on Quality of Life
Official title: The Effect of Mobile-Based Education Given to Patients Undergoing Gynecological Oncology Surgery on Quality of Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Keywords: Gynecological oncology
Mobile application
Nursing care
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The education given with the mobile application in gynecological oncology patients positively affects the quality of life of the patients.
timeFrame: Women will be evaluated two weeks after surgery.
Secondary outcomes:
measure: Education given with mobile application in gynecological oncology patients positively affects symptom control of patients.
timeFrame: Women will be evaluated two weeks after surgery.
Other outcomes:
Locations:
city: Avcılar
country: Turkey
facility: Istanbul University-Cerrahpasa
state: İstanbul
Study officials:
affiliation: PhD student
name: Çisem Baştarcan
role: PRINCIPAL_INVESTIGATOR
References: