- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06509529
The Effect of Motivational Interviewing Based on the COM-B Model
July 14, 2024 updated by: Hacer Gok Ugur, T.C. ORDU ÜNİVERSİTESİ
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hacer GÖK UĞUR, Assoc.Prof.
- Phone Number: 04522265200
- Email: hacer32@gmail.com
Study Contact Backup
- Name: Züleyha Çakır, Nurse
- Phone Number: 04522265200
- Email: cakirzuleyha.379@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
- Has an internet connection,
- Open to communication and collaboration,
- Women who volunteer to participate in the study will be included in the study.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
Motivational interviews based on the COM-B Model will be given to the women in the experimental group.
|
Motivational Interviewing Based on the COM-B Model will be applied to the women in the experimental group.
|
|
No Intervention: control group
They will receive routine cancer screening information provided by the institution.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
"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.
|
0th month and 1st month.
|
|
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.
|
0th month and 1st month.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hacer GÖK UĞUR, Assoc.Prof., T.C. ORDU ÜNİVERSİTESİ
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 15, 2024
Primary Completion (Estimated)
December 30, 2024
Study Completion (Estimated)
January 30, 2025
Study Registration Dates
First Submitted
July 14, 2024
First Submitted That Met QC Criteria
July 14, 2024
First Posted (Actual)
July 19, 2024
Study Record Updates
Last Update Posted (Actual)
July 19, 2024
Last Update Submitted That Met QC Criteria
July 14, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
Other Study ID Numbers
- Ordu1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
-
University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
-
M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
-
Tata Memorial HospitalMahidol University; Juntendo University; Gunma University; Chiang Mai University...RecruitingStage IIA Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO 2018 | Stage IIIB Cervical Cancer FIGO 2018 | Stage IVA Cervical Cancer FIGO 2018 | Stage IB Cervical Cancer FIGO 2018India, Japan, Thailand
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
-
Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
-
Qi ZhouNot yet recruitingCervical Cancer Recurrent | Cervical Cancer Metastatic
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNot yet recruitingCervical Cancer Recurrent | Cervical Cancer Metastatic
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
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M.D. Anderson Cancer CenterRecruitingCervical Large Cell Neuroendocrine Carcinoma | Cervical Neuroendocrine Carcinoma | Cervical Small Cell Carcinoma | Cervical Undifferentiated Carcinoma | Stage I Cervical Cancer AJCC v8 | Stage IA Cervical Cancer AJCC v8 | Stage IA1 Cervical Cancer AJCC v8 | Stage IA2 Cervical Cancer AJCC v8 | Stage... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
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