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Mobile Health Application Developed for Cervical Cancer

Primary Purpose

Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mobile application usage
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring MOBİLE HEALTH, CERVİCAL CANCER, AWARENESS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Being 18 and over
  • Able to understand and speak Turkish
  • ability to read and write
  • Owning a smartphone

Exclusion Criteria:

  • Having a communication barrier (seeing, understanding...)
  • Having been diagnosed with cervical cancer in himself or his first degree relatives
  • Not wanting to leave work
  • the lost of life,
  • Not participating in the final tests,
  • Failure to complete parts of the mobile application within the specified time,

Sites / Locations

  • Gazi UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1. group

2. group

Arm Description

participants will receive information about cervical cancer with the developed mobile application.

No Intervention: control group (non-education) Routıne care

Outcomes

Primary Outcome Measures

Mobile Health Application questionnaire: "There is "NO" difference in the mean scores of Cervical Cancer and Pap Smear Test Health Belief Model Scale between women who received
In the nursing care given with the mobile health application for cervical cancer, in the experimental and control groups
Mobile Health Application questionnaire: "There is "YES' difference in the mean scores of Cervical Cancer and Pap Smear Test Health Belief Model Scale between women who received
the nursing care given with the mobile health application for cervical cancer, in the experimental and control groups

Secondary Outcome Measures

Full Information

First Posted
April 21, 2022
Last Updated
May 17, 2022
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05378542
Brief Title
Mobile Health Application Developed for Cervical Cancer
Official Title
Evaluation of the Efficiency of Nursing Care Given Through the Mobil Health Application Developed for Cervical Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of this research is to evaluate the effect of the nursing care that participants receive with the mobile health application for cervical cancer on raising awareness about cervical cancer. The study conducted through the mobile health application developed to raise awareness about cervical cancer; It is thought that it is important in terms of raising awareness of participants, easing the work-time burden of health personnel in this period, and reducing the cost of health care through early diagnosis and treatment, and will set an example for future studies. Positive outputs from the mobile application will allow the application to be used on national and international platforms.
Detailed Description
In the face-to-face health care system, especially due to the pandemic period, the problem of personnel need to provide health care can be solved with mobile health applications; thus, mobile health applications can indirectly help workforce problems. Mobile applications allow the provision of high quality, useful services with less energy and cost to large audiences. In addition, mobile health applications allow patients to be followed remotely, allowing patients to access health services wherever, whenever and as often as they want. It is stated that well-structured mobile applications have a positive impact on the health sector. In this context, it is seen that the use of mobile applications in primary, secondary and tertiary healthcare services is becoming increasingly common all over the world. In researches planned study, it is aimed to develop a mobile application in Turkish in order to raise awareness about cervical cancer and to evaluate its effectiveness. In the content of the mobile application to be developed, information about cervical cancer such as information about cervical cancer, symptoms, findings, diagnosis, screening, treatment, practical explanations with video, frequently asked questions about the subject; It is planned to have interim notifications, reminders, pay attention warning messages. There are a limited number of practices related to cervical cancer awareness in the world. In Turkey, there is no e-health mobile application for cervical cancer awareness. Unlike the applications in the world; In the application, which is aimed to be developed in this study, there is an area where the participants can ask questions to the researcher from the "Request Support" section and there is a field. The information provided by mobile health applications was found to be educational, appropriate, original and on-site, and it was found useful to be reliable. Studies have shown that mobile health applications contribute to positive health outcomes. The study conducted through the mobile health application developed to raise awareness about cervical cancer; It is thought that it is important in terms of raising the awareness of participants, easing the work-time burden of health personnel in this period, and reducing the cost of health care through early diagnosis and treatment, and will set an example for future studies. Positive outputs from the mobile application will allow the application to be used on national and international platforms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
MOBİLE HEALTH, CERVİCAL CANCER, AWARENESS

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The research is a single center, parallel group, stratified block randomized controlled experimental study.
Masking
ParticipantOutcomes Assessor
Masking Description
Stratified block randomization will be used to avoid selection bias. In this study on application bias, researcher and participant blinding will not be done. Because the researcher will make the application himself and placebo cannot be used in the intervention. Data collection forms to prevent detection bias will be applied online through Google Forms® independently of the researcher. The data obtained from the research aimed at preventing reporting bias will be coded as A and B by an independent researcher and transferred to the SPSS program. Analysis of the data will also be done by an independent statistician. In order to prevent attrition bias, Intention to Treat Test will be used in the sample group in case of missing/subtracting or not completing the post-tests.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1. group
Arm Type
Active Comparator
Arm Description
participants will receive information about cervical cancer with the developed mobile application.
Arm Title
2. group
Arm Type
No Intervention
Arm Description
No Intervention: control group (non-education) Routıne care
Intervention Type
Behavioral
Intervention Name(s)
Mobile application usage
Intervention Description
The implementation of the research was carried out in two stages. In the first stage, a mobile application was created, in the second stage, training and counseling was given to the experimental group with the mobile application, and no attempt was made to the control group.
Primary Outcome Measure Information:
Title
Mobile Health Application questionnaire: "There is "NO" difference in the mean scores of Cervical Cancer and Pap Smear Test Health Belief Model Scale between women who received
Description
In the nursing care given with the mobile health application for cervical cancer, in the experimental and control groups
Time Frame
2 months
Title
Mobile Health Application questionnaire: "There is "YES' difference in the mean scores of Cervical Cancer and Pap Smear Test Health Belief Model Scale between women who received
Description
the nursing care given with the mobile health application for cervical cancer, in the experimental and control groups
Time Frame
2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being 18 and over Able to understand and speak Turkish ability to read and write Owning a smartphone Exclusion Criteria: Having a communication barrier (seeing, understanding...) Having been diagnosed with cervical cancer in himself or his first degree relatives Not wanting to leave work the lost of life, Not participating in the final tests, Failure to complete parts of the mobile application within the specified time,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SEÇİL GÜNEYSU TUNAMAN
Phone
05539751733
Email
guneysu06@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
seçil güneysu tunaman
Organizational Affiliation
bursa provincial health directorate
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gazi University
City
Ankara
ZIP/Postal Code
6450
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Şengül Y Sözbir
Phone
03122162609

12. IPD Sharing Statement

Plan to Share IPD
No

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Mobile Health Application Developed for Cervical Cancer

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