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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05694208
Other study ID # CBastarcan
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date June 30, 2024

Study information

Verified date January 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact Çisem Bastarcan
Phone +90 (539) 399 4032
Email cisembastarcan@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date June 30, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Avcilar Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The education given with the mobile application in gynecological oncology patients positively affects the quality of life of the patients. The patients' quality of life will be measured with Functional Assessment of Cancer Therapy-General (FACT-G). All questions are aimed at assessing the patients' quality of life in the last 7 days. A higher score from the scale indicates a better quality of life. Women will be evaluated two weeks after surgery.
Secondary Education given with mobile application in gynecological oncology patients positively affects symptom control of patients. The patients' symptom will be measured with Symptom Evaluation Form. The symptom evaluation form was created by the researchers by scanning the relevant literature and determining the most common postoperative symptoms of patients who underwent gynecological oncology surgery. Women will be evaluated two weeks after surgery.
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