NCT05694208

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

1.9 years

First QC Date

January 12, 2023

Last Update Submit

November 13, 2024

Conditions

Keywords

Gynecological oncologyMobile applicationNursing care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Women will be evaluated two weeks after surgery.

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Behavioral: Education Group

Control Group

NO INTERVENTION

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

Interventions

Education GroupBEHAVIORAL

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.

Experimental group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Having a diagnosis of active psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Avcılar, Istanbul, 34320, Turkey (Türkiye)

RECRUITING

Study Officials

  • Çisem Baştarcan

    PhD student

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 23, 2023

Study Start

February 1, 2023

Primary Completion

December 30, 2024

Study Completion

January 1, 2025

Last Updated

November 15, 2024

Record last verified: 2024-11

Locations