Cervical CancerNCT06509529
The Effect of Motivational Interviewing Based on the COM-B Model
A study testing Motivational Interviewing Based on the COM-B Model in people with Cervical Cancer, run by Ordu University.
Trial summary
This research will be conducted to determine the effect of motivational interviewing based on the COM-B model on women's cervical cancer health beliefs and participation in screening. 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
- Cervical Cancer
- What is being tested?
- Motivational Interviewing Based on the COM-B Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2024to 30 Jan 2025
- 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
- Registered at Altınordu Central Family Health Center,
- A woman,
- Between 30-65 years of age,
- The one who is married,
- Have not had a Pap Smear test in the last 5 years,
- Has a smart phone
Show all 9Show fewer
- Has an internet connection,
- Open to communication and collaboration,
- Women who volunteer to participate in the study will be included in the study.
Who cannot join
- Who had total hysterectomy surgery,
- The pregnant one,
- Those diagnosed with cervical cancer and
- Women with a psychiatric diagnosis will be excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Motivational Interviewing Based on the COM-B Model on Women's Cervical Cancer Health Beliefs and Participation in Screening: A Single-Blind Randomized Controlled Study
This research will be conducted to determine the effect of motivational interviewing based on the COM-B model on women's cervical cancer health beliefs and participation in screening.
Read the detailed description
Cancer is an important public health problem in terms of mortality and morbidity in the world and in our country, and ranks second among the causes of death. It can reduce the mortality and morbidity rate in cancer with early diagnosis and screening studies. One of the cancers for which early diagnosis and screening studies are carried out in women is cervical cancer, and it is the 4th most frequently diagnosed cancer type that causes death in women. Although early diagnosis and screening studies are carried out, women do not participate in enough cervical cancer screenings for different reasons. Interventions are needed to increase women's motivation to participate in screening. This research will be conducted to determine the effect of motivational interviewing based on the COM-B model on women's cervical cancer health beliefs and participation in screening. The research is planned as a parallel group single-blind randomized controlled experimental study and will be conducted on women between the ages of 30-65 who are registered at Altınordu Central Family Health Center in Ordu Province. The population of the research will be women between the ages of 30-65 who are registered at Altınordu Central Family Health Center, and the sample will be 74 women who meet the research criteria and agree to participate in the research. The data of the research will be collected with the "Information Form", "Cervical Cancer and Pap Smear Test Health Belief Model Scale", "Cervical Cancer Screening Status Evaluation Form" and "Satisfaction Evaluation Form". A motivational interview program based on the COM-B Model will be applied to the women in the experimental group for 1 month (1st week face-to-face, 2nd, 3rd and 4th weeks online). No intervention will be applied to the control group during the research process. The analysis of the data will be done in a computer environment by an expert statistician. Necessary institutional permissions and ethics committee approval will be obtained for the research.
- Conditions
- Cervical Cancer
- Being tested
- Motivational Interviewing Based on the COM-B Model
- Keywords
- Cervical Cancer, Motivational Interviewing, Early Diagnosis and Screening, Health Beliefs, Nursing, COM-B Model
- Medical subject headings
- Uterine Cervical Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing Based on the COM-B ModelOther
Motivational Interviewing Based on the COM-B Model will be applied to the women in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Motivational interviews based on the COM-B Model will be given to the women in the experimental group. Receives: Other: Motivational Interviewing Based on the COM-B Model |
| control group | No intervention | They will receive routine cancer screening information provided by the institution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Cervical Cancer and Pap Smear Test Health Belief Model Scale"
The scale was developed by Güvenç et al. (2011). Higher scores from the scale indicate increased sensitivity, caring and motivation; It indicates that benefits are perceived as high for benefit perception and obstacles are perceived as high for obstacle perception.
Measured: 0th month and 1st month.
Status of Cervical Cancer Screening
This form was prepared by the researcher and will evaluate women's status of being screened for cervical cancer.
Measured: 0th month and 1st month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start15 Aug 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacer Gok Ugur, Ordu University
- Investigators
- Hacer GÖK UĞUR, Assoc.Prof., Study director, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509529
- Sponsor's protocol ID
- Ordu1
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 19 Jul 2024
- 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 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviewing Based on the COM-B Model on Women's Cervical Cancer Health Beliefs and Participation in Screening: A Single-Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06509529
- Acronym / sponsor ID
- Ordu1
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, Motivational Interviewing, Early Diagnosis and Screening, Health Beliefs, Nursing, COM-B Model
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 19 Jul 2024 (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.
This research will be conducted to determine the effect of motivational interviewing based on the COM-B model on women's cervical cancer health beliefs and participation in screening.
Detailed description
Cancer is an important public health problem in terms of mortality and morbidity in the world and in our country, and ranks second among the causes of death. It can reduce the mortality and morbidity rate in cancer with early diagnosis and screening studies. One of the cancers for which early diagnosis and screening studies are carried out in women is cervical cancer, and it is the 4th most frequently diagnosed cancer type that causes death in women. Although early diagnosis and screening studies are carried out, women do not participate in enough cervical cancer screenings for different reasons. Interventions are needed to increase women's motivation to participate in screening. This research will be conducted to determine the effect of motivational interviewing based on the COM-B model on women's cervical cancer health beliefs and participation in screening. The research is planned as a parallel group single-blind randomized controlled experimental study and will be conducted on women between the ages of 30-65 who are registered at Altınordu Central Family Health Center in Ordu Province. The population of the research will be women between the ages of 30-65 who are registered at Altınordu Central Family Health Center, and the sample will be 74 women who meet the research criteria and agree to participate in the research. The data of the research will be collected with the "Information Form", "Cervical Cancer and Pap Smear Test Health Belief Model Scale", "Cervical Cancer Screening Status Evaluation Form" and "Satisfaction Evaluation Form". A motivational interview program based on the COM-B Model will be applied to the women in the experimental group for 1 month (1st week face-to-face, 2nd, 3rd and 4th weeks online). No intervention will be applied to the control group during the research process. The analysis of the data will be done in a computer environment by an expert statistician. Necessary institutional permissions and ethics committee approval will be obtained for the research.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Motivational Interviewing Based on the COM-B ModelMotivational interviews based on the COM-B Model will be given to the women in the experimental group. |
| control group | No intervention | –They will receive routine cancer screening information provided by the institution. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Registered at Altınordu Central Family Health Center,
- A woman,
- Between 30-65 years of age,
- The one who is married,
- Have not had a Pap Smear test in the last 5 years,
Key exclusion criteria (4 listed)
- Who had total hysterectomy surgery,
- The pregnant one,
- Those diagnosed with cervical cancer and
- Women with a psychiatric diagnosis will be excluded from the study.
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 |
|---|---|---|
| Motivational Interviewing Based on the COM-B ModelMotivational Interviewing Based on the COM-B Model will be applied to the women in the experimental group. | Other | Experimental group |
Primary outcome
"Cervical Cancer and Pap Smear Test Health Belief Model Scale"
Time frame: 0th month and 1st month.
The scale was developed by Güvenç et al. (2011). Higher scores from the scale indicate increased sensitivity, caring and motivation; It indicates that benefits are perceived as high for benefit perception and obstacles are perceived as high for obstacle perception.
Status of Cervical Cancer Screening
Time frame: 0th month and 1st month.
This form was prepared by the researcher and will evaluate women's status of being screened for cervical cancer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- 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.
Hacer GÖK UĞUR, Assoc.Prof. study director
Ordu University
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing Based on the COM-B Model in people with Cervical Cancer, run by Ordu University.
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 9 inclusion and 4 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 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Hacer GÖK UĞUR, Assoc.Prof. (04522265200, hacer32@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Cervical Cancer and Pap Smear Test Health Belief Model Scale" (time frame: 0th month and 1st month.). 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 19 Jul 2024.