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

Sponsor
Istanbul University - Cerrahpasa (IUC) (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05694208
Collaborator
(none)
70
1
2
16.9
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Education Group
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Mobile-Based Education Given to Patients Undergoing Gynecological Oncology Surgery on Quality of Life
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group

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

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.

No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University-Cerrahpasa Avcılar İstanbul Turkey 34320

Sponsors and Collaborators

  • Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Çisem Baştarcan, PhD student

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Çisem Baştarcan, PhD student, Istanbul University - Cerrahpasa (IUC)
ClinicalTrials.gov Identifier:
NCT05694208
Other Study ID Numbers:
  • CBastarcan
First Posted:
Jan 23, 2023
Last Update Posted:
Jan 23, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Çisem Baştarcan, PhD student, Istanbul University - Cerrahpasa (IUC)

Study Results

No Results Posted as of Jan 23, 2023