NCT05378542

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

April 21, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

April 22, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

April 21, 2022

Last Update Submit

May 17, 2022

Conditions

Keywords

MOBİLE HEALTH, CERVİCAL CANCER, AWARENESS

Outcome Measures

Primary Outcomes (2)

  • 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

    2 months

  • 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

    2 months

Study Arms (2)

1. group

ACTIVE COMPARATOR

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

Behavioral: Mobile application usage

2. group

NO INTERVENTION

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

Interventions

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.

1. group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, 6450, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

NeoplasmsUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • seçil güneysu tunaman

    bursa provincial health directorate

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SEÇİL GÜNEYSU TUNAMAN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research is a single center, parallel group, stratified block randomized controlled experimental study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 21, 2022

First Posted

May 18, 2022

Study Start

April 22, 2022

Primary Completion

July 1, 2022

Study Completion

August 1, 2022

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations