- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05353387
The Effect of the Motivational Interviewing Technique on Breast and Cervical Cancer Screenings
The Effect of the Motivational Interviewing Technique Applied to Women in the Menopause Period on Their Participation in Breast and Cervical Cancer Screenings
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will be conducted to evaluate the effect of the motivational interviewing technique applied to menopausal women on their participation in breast and cervical cancer screenings. This is a randomized controlled intervention study in which the study sample will consist of 120 menopausal women, who visit the health care centers in the city of Kutahya. There will be one intervention group with a total of 60 participants and a control group with the same number of participants. The intervention group will have motivational interviews whereas the control group participants will follow the normal protocols.
The Turkish version of Champion's Health Belief Model Scale and The Health Belief Model Scale for Cervical Cancer and the Pap Smear Test will be applied to all the participants in both groups.
Then for the intervention group, the motivational interviewing will be carried out in 3 different sessions, each to be conducted one week apart. 6 weeks after the last interview, first follow up would be conducted through phone communication and 6 weeks after the first follow up, a face-to-face interview would be conducted for the scales to be applied to the participants again. For the control group, the scales will be applied for the second time at the same time as the intervention group and they will be given a training manual and their questions will be answered by the researchers.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tuğba ÖZTÜRK, PhD
- Phone Number: +905305279492
- Email: tugba.ozturk@ksbu.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Visiting any family health centers in the city of Kütahya,
- Without any cancer diagnosis and treatment,
- Not having had a clinical breast examination in the last 1 year, with no natural menstrual period in the last 1 year, have entered menopause and are 69 years old (included) maximum,
- Without a mammogram in the last 2 years in women who have gone through menopause and are 69 years old (included).
- Without an HPV or Pap smear test in the last 5 years in women who have entered menopause and are in the age range of 65 (including),
- Being literate,
- Able to communicate.
Exclusion Criteria:
- Having been diagnosed with any cancer,
- Inability to communicate,
- Failure to continue the phases of the study for any reason.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group- Motivational Interviewing
Standard protocols and participation in Motivational Interviews
|
Motivational Interviewing will be carried out in 3 different sessions, each to be conducted one week apart.
6 weeks after the last interview, first follow up would be conducted through phone communication and 6 weeks after the first follow up, a face-to-face interview would be conducted for the scales to be applied to the participants again.
|
No Intervention: Control Group
Standard protocols
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Turkish Version of Champion's Health Belief Model Scale (CHBMS-T)
Time Frame: 4 Months Questions were answered on a 5-point Likert-type response scale ranging from 1 (strongly disagree) to 5 (strongly agree), and mean scores were computed for each subscale.
|
Champion's Health Belief Model Scale (CHBMS), developed by Champion in 1984 and revised in 1993, is used to measure women's beliefs about breast cancer and breast self-examination (BSE).
The Turkish Version of the Champion's Health Belief Model Scale was validated by Gözüm and Aydın in 2004 with 8 sub-dimensions and 58 items.
Questions were answered on a 5-point Likert-type response scale ranging from 1 (strongly disagree) to 5 (strongly agree), and mean scores were computed for each subscale.
The total score that can be obtained from the scale is 58 minimum and 290 maximum.
Thus, higher scores represent perceptions of greater susceptibility to breast cancer, greater benefits from screening, and higher barriers to screening.
The opposite was expected for higher perceived barriers.
A total scale score was also derived by computing the mean of the mean subscale scores, with barriers reverse coded.
|
4 Months Questions were answered on a 5-point Likert-type response scale ranging from 1 (strongly disagree) to 5 (strongly agree), and mean scores were computed for each subscale.
|
The Health Belief Model Scale for Cervical Cancer and the Pap Smear Test(HBMSCCPS)
Time Frame: 4 Months
|
Developed by Champion for breast cancer and mammography, this scale, which was adapted to cervical cancer and pap smear test by Güvenç, Akyüz, and Açıkel in 2011, is used to investigate the beliefs of women in respect of cervical cancer and the Pap Smear Test to assist healthcare professionals to develop more effective cervical cancer screening programmes.
The scale consists of 35 items and five main dimensions.
Questions were answered on a 5-point Likert-type response scale ranging from 1 (strongly disagree) to 5 (strongly agree).
The total score that can be obtained from the scale is 35 minimum and 175 maximum.
The higher scores indicate agreement with the beliefs of health assessment.
|
4 Months
|
Collaborators and Investigators
Investigators
- Study Director: Gülşah KÖK, Asst. Prof., Department of Obstetrics and Gynecology Nursing, Gulhane Nursing Faculty, Health Sciences University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/73
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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