CancerNCT05378542
Mobile Health Application Developed for Cervical Cancer
A study testing Mobile application usage in people with Cancer, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Mobile application usage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Apr 2022to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 and over
- Able to understand and speak Turkish
- ability to read and write
- Owning a smartphone
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University
Ankara, 6450
Şengül Y Sözbir, 03122162609
About this study
Official title: Evaluation of the Efficiency of Nursing Care Given Through the Mobil Health Application Developed for Cervical Cancer.
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Mobile application usage
- Keywords
- MOBİLE HEALTH, CERVİCAL CANCER, AWARENESS
- Medical subject headings
- Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile application usageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1. group | Active comparator | participants will receive information about cervical cancer with the developed mobile application. Receives: Behavioral: Mobile application usage |
| 2. group | No intervention | No Intervention: control group (non-education) Routıne care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start22 Apr 2022
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research is a single center, parallel group, stratified block randomized controlled experimental study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şengül Yaman Sözbir, Gazi University
- Investigators
- seçil güneysu tunaman, Principal investigator, bursa provincial health directorate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378542
- Sponsor's protocol ID
- 006scltnmn
- Status last verified
- May 2022
- First submitted
- 21 Apr 2022
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Nursing Care Given Through the Mobil Health Application Developed for Cervical Cancer.
- ClinicalTrials.gov ID
- NCT05378542
- Acronym / sponsor ID
- 006scltnmn
- Conditions
- Cancer
- Keywords
- MOBİLE HEALTH, CERVİCAL CANCER, AWARENESS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The research is a single center, parallel group, stratified block randomized controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| 1. group | Active comparator | Behavioral: Mobile application usageparticipants will receive information about cervical cancer with the developed mobile application. |
| 2. group | No intervention | –No Intervention: control group (non-education) Routıne care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being 18 and over
- Able to understand and speak Turkish
- ability to read and write
- Owning a smartphone
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile application usageThe 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. | Behavioural | 1. group |
Primary outcome
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
Time frame: 2 months
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
Time frame: 2 months
the nursing care given with the mobile health application for cervical cancer, in the experimental and control groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
seçil güneysu tunaman principal investigator
bursa provincial health directorate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application usage in people with Cancer, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SEÇİL GÜNEYSU TUNAMAN (05539751733, guneysu06@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.