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NCT Number: NCT05694208

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa

Avcılar, Istanbul, 34320, Turkey (Türkiye)

Location status: Recruiting

Location contact

Çisem Baştarcan

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education group

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.

Primary outcomes

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

    Time frame: Women will be evaluated two weeks after surgery.

    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.

Secondary outcomes

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

    Time frame: Women will be evaluated two weeks after surgery.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cisem Bastarcan

CONTACT

[email protected]

+90 (539) 399 4032

Çisem Baştarcan

CONTACT

[email protected]

+90 (539) 399 4032

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 23, 2023
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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