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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05353387
Other study ID # 2022/73
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 30, 2022
Est. completion date October 30, 2022

Study information

Verified date April 2022
Source Istanbul Saglik Bilimleri University
Contact Tugba ÖZTÜRK, PhD
Phone +905305279492
Email tugba.ozturk@ksbu.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date October 30, 2022
Est. primary completion date October 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A to 69 Years
Eligibility 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 Design


Intervention

Other:
Motivational Interviewing
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Saglik Bilimleri University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Aydin 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.
Primary 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 Açikel 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
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