MenopauseNCT05353387
The Effect of the Motivational Interviewing Technique on Breast and Cervical Cancer Screenings
A study testing Motivational Interviewing in people with Menopause and Cervix Cancer, run by Istanbul Saglik Bilimleri University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Cervix Cancer, Breast Cancer
- What is being tested?
- Motivational Interviewing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2022to 30 Oct 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 Up to 69 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Having been diagnosed with any cancer,
- Inability to communicate,
- Failure to continue the phases of the study for any reason.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of the Motivational Interviewing Technique Applied to Women in the Menopause Period on Their Participation in Breast and Cervical Cancer Screenings
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.
Read the 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.
- Conditions
- Menopause, Cervix Cancer, Breast Cancer
- Being tested
- Motivational Interviewing
- Medical subject headings
- Uterine Cervical Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group- Motivational Interviewing | Experimental | Standard protocols and participation in Motivational Interviews Receives: Other: Motivational Interviewing |
| Control Group | No intervention | Standard protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turkish Version of Champion's Health Belief Model Scale (CHBMS-T)
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.
Measured: 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)
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.
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start30 Apr 2022 (estimated)
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba OZTURK, Istanbul Saglik Bilimleri University
- Investigators
- Gülşah KÖK, Asst. Prof., Study director, Department of Obstetrics and Gynecology Nursing, Gulhane Nursing Faculty, Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353387
- Sponsor's protocol ID
- 2022/73
- Status last verified
- Apr 2022
- First submitted
- 23 Apr 2022
- Last updated
- 5 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 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Motivational Interviewing Technique Applied to Women in the Menopause Period on Their Participation in Breast and Cervical Cancer Screenings
- ClinicalTrials.gov ID
- NCT05353387
- Acronym / sponsor ID
- 2022/73
- Conditions
- Menopause, Cervix Cancer, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 30 Apr 2022 (estimated)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 29 Apr 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group- Motivational Interviewing | Experimental | Other: Motivational InterviewingStandard protocols and participation in Motivational Interviews |
| Control Group | No intervention | –Standard protocols |
Who may qualify
- Ages
- Up to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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),
Key exclusion criteria (3 listed)
- Having been diagnosed with any cancer,
- Inability to communicate,
- Failure to continue the phases of the study for any reason.
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 InterviewingMotivational 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. | Other | Intervention Group- Motivational Interviewing |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 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.
Gülşah KÖK, Asst. Prof. study director
Department of Obstetrics and Gynecology Nursing, Gulhane Nursing Faculty, Health Sciences University
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing in people with Menopause and Cervix Cancer, run by Istanbul Saglik Bilimleri 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 7 inclusion and 3 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 5 May 2022. 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 Tuğba ÖZTÜRK, PhD (+905305279492, tugba.ozturk@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 5 May 2022.