Early Detection of CancerNCT06021496
The Effect of Face-to-face and Online Health Education on Women's Cervical Cancer Knowledge, Health Beliefs and Screening
A study testing face to face health education and online health education in people with Early Detection of Cancer, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this study is to determine the effect of health education given by two different methods on women's knowledge about HPV, cervical cancer health belief and screening test. Materials and Methods: The study was conducted in a parallel groups design as a single-blind randomized controlled trial. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Early Detection of Cancer
- What is being tested?
- face to face health education and online health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2023to 15 May 2023
- 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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- The criteria for not being included in this study are;
- Being pregnant or in the postpartum trimester,
- Having a family history of cervical cancer,
- Having had a hysterectomy operation,
- To have received any previous training on cervical cancer,
- Having a vaginal infection,
- To be vaccinated against HPV (3 doses). -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Two Different Methods of Health Education on Women's HPV Knowledge, Cervical Cancer Health Belief and Screening
Aim: The aim of this study is to determine the effect of health education given by two different methods on women's knowledge about HPV, cervical cancer health belief and screening test.
Materials and Methods: The study was conducted in a parallel groups design as a single-blind randomized controlled trial. The sample consisted of 126 healthy participants, 42 in each volunteer group, who were registered at the Martyr Zafer Çalışkan Family Health Center in Ankara between January and July 2023, and met the inclusion criteria. HPV Knowledge scale, Cervical Cancer and pap Smear Test Health Belief Model Scale and VAS for self-assessment were used in the study. In the study, while the control group received standard care, the face-to-face education group was given health education and brochures through home visits and a reminder interview over the phone; On the other hand, the online training group was given health education and a digital brochure via video call and a reminder meeting was held once. One-way analysis of variance and Kruskal Wallis test were used to compare the data of the three groups after a two-month follow-up, Tukey and Dunn test for multiple comparisons, and Wilcoxon test for in-group comparisons before and after. In addition, two-way analysis of variance and Robust ANOVA were used in group and time comparisons.
Read the detailed description
In this randomized controlled trial, participants were assigned to three groups by the block randomization method and the study was conducted in a single-blind parallel groups design. It was carried out at Martyr Zafer Çalışkan Family Health Center between January 2023 and July 2023. The eligibility of female participants between the ages of 30-65 to participate in the study was evaluated by the researcher. The sample size was calculated based on the rate of cervical cancer screening test in Kurt and Akyüz's study. G Power 3.1.9.2 package program was used in the calculation. Taking into account possible data loss, it was decided to add 30% backup participants. In this context, the sample of the study was calculated as 126 participants, 42 in each group. The patients who volunteered to participate in the study were examined whether they met the inclusion criteria other than the level of drug compliance. Written informed consent was obtained from the participants who met the inclusion criteria and a questionnaire form was applied. Participants were assigned to groups using the block randomization method. No intervention was made in the control group. At the end of the following first week, face-to-face and online training was provided with the participants in the online training group, one-to-one home visits, face-to-face training and video calls. Four weeks later, a brief reminder was made by phone call. At the end of eight weeks, a second questionnaire was applied to all groups.
- Conditions
- Early Detection of Cancer
- Being tested
- face to face health education, online health education
- Keywords
- Cervical Cancer, Cervical Cancer Screening, Health Education, Online Education, Home Visit
- Medical subject headings
- Uterine Cervical Neoplasms, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
face to face health educationBehavioural
Face-to-face health education with home visit
online health educationBehavioural
online health education with video call
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Participants in the control group continued to receive standard cervical cancer screening service of the Ministry of Health. No further intervention was made. |
| Face-to-face training group | Experimental | In addition to the standard cervical screening service of the Ministry of Health, face-to-face health education through home visits and a reminder by phone call were made once.
brochure given Receives: Behavioral: face to face health education |
| Online training group | Experimental | In addition to the standard cervical screening service of the Ministry of Health, online health education via video call and a reminder with a phone call once. A digital brochure was given. Receives: Behavioral: online health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV Knowledge Scale
HPV Knowledge Scale consists of 4 sub-dimensions and 33 items. Participants score between 0-33.
Measured: 60 days
Secondary outcomes (1)
Cervical Cancer and Pap Smear Test Health Belief Model Scale
Although the scale is graded in a 5-point Likert type, it consists of a total of 35 items. The higher the scores obtained from the scale, the higher the sensitivity, caring and motivation; It means that benefits are perceived high for the perception of benefit, and obstacles are perceived high for the perception of obstacles.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start14 Feb 2023
- Primary completion5 Mar 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Detection of CancerStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised control trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil Özdemir, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- merve gökmen, Principal investigator, Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021496
- Sponsor's protocol ID
- CERVİCAL CANCER
- Status last verified
- Aug 2023
- First submitted
- 18 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Methods of Health Education on Women's HPV Knowledge, Cervical Cancer Health Belief and Screening
- ClinicalTrials.gov ID
- NCT06021496
- Acronym / sponsor ID
- CERVİCAL CANCER
- Conditions
- Early Detection of Cancer
- Keywords
- Cervical Cancer, Cervical Cancer Screening, Health Education, Online Education, Home Visit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 5 Mar 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 1 Sep 2023 (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.
Aim: The aim of this study is to determine the effect of health education given by two different methods on women's knowledge about HPV, cervical cancer health belief and screening test.
Materials and Methods: The study was conducted in a parallel groups design as a single-blind randomized controlled trial. The sample consisted of 126 healthy participants, 42 in each volunteer group, who were registered at the Martyr Zafer Çalışkan Family Health Center in Ankara between January and July 2023, and met the inclusion criteria. HPV Knowledge scale, Cervical Cancer and pap Smear Test Health Belief Model Scale and VAS for self-assessment were used in the study. In the study, while the control group received standard care, the face-to-face education group was given health education and brochures through home visits and a reminder interview over the phone; On the other hand, the online training group was given health education and a digital brochure via video call and a reminder meeting was held once. One-way analysis of variance and Kruskal Wallis test were used to compare the data of the three groups after a two-month follow-up, Tukey and Dunn test for multiple comparisons, and Wilcoxon test for in-group comparisons before and after. In addition, two-way analysis of variance and Robust ANOVA were used in group and time comparisons.
Detailed description
In this randomized controlled trial, participants were assigned to three groups by the block randomization method and the study was conducted in a single-blind parallel groups design. It was carried out at Martyr Zafer Çalışkan Family Health Center between January 2023 and July 2023. The eligibility of female participants between the ages of 30-65 to participate in the study was evaluated by the researcher. The sample size was calculated based on the rate of cervical cancer screening test in Kurt and Akyüz's study. G Power 3.1.9.2 package program was used in the calculation. Taking into account possible data loss, it was decided to add 30% backup participants. In this context, the sample of the study was calculated as 126 participants, 42 in each group. The patients who volunteered to participate in the study were examined whether they met the inclusion criteria other than the level of drug compliance. Written informed consent was obtained from the participants who met the inclusion criteria and a questionnaire form was applied. Participants were assigned to groups using the block randomization method. No intervention was made in the control group. At the end of the following first week, face-to-face and online training was provided with the participants in the online training group, one-to-one home visits, face-to-face training and video calls. Four weeks later, a brief reminder was made by phone call. At the end of eight weeks, a second questionnaire was applied to all groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomised control trial
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Participants in the control group continued to receive standard cervical cancer screening service of the Ministry of Health. No further intervention was made. |
| Face-to-face training group | Experimental | Behavioral: face to face health educationIn addition to the standard cervical screening service of the Ministry of Health, face-to-face health education through home visits and a reminder by phone call were made once. brochure given |
| Online training group | Experimental | Behavioral: online health educationIn addition to the standard cervical screening service of the Ministry of Health, online health education via video call and a reminder with a phone call once. A digital brochure was given. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- The criteria for not being included in this study are;
- Being pregnant or in the postpartum trimester,
- Having a family history of cervical cancer,
- Having had a hysterectomy operation,
- To have received any previous training on cervical cancer,
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 |
|---|---|---|
| face to face health educationFace-to-face health education with home visit | Behavioural | Face-to-face training group |
| online health educationonline health education with video call | Behavioural | Online training group |
Primary outcome
HPV Knowledge Scale
Time frame: 60 days
HPV Knowledge Scale consists of 4 sub-dimensions and 33 items. Participants score between 0-33.
1 secondary outcome
Cervical Cancer and Pap Smear Test Health Belief Model Scale
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- 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.
merve gökmen principal investigator
Ministry of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing face to face health education and online health education in people with Early Detection of Cancer, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi 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 0 inclusion and 7 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: finished, as of the sponsor's last update on 1 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV Knowledge Scale (time frame: 60 days). 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 1 Sep 2023.