The Effect of the Motivational Interviewing Technique on Breast and Cervical Cancer Screenings
Primary Purpose
Menopause, Cervix Cancer, Breast Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motivational Interviewing
Sponsored by
About this trial
This is an interventional supportive care trial for Menopause
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group- Motivational Interviewing
Control Group
Arm Description
Standard protocols and participation in Motivational Interviews
Standard protocols
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05353387
First Posted
April 23, 2022
Last Updated
April 29, 2022
Sponsor
Istanbul Saglik Bilimleri University
1. Study Identification
Unique Protocol Identification Number
NCT05353387
Brief Title
The Effect of the Motivational Interviewing Technique on Breast and Cervical Cancer Screenings
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 30, 2022 (Anticipated)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Saglik Bilimleri University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Cervix Cancer, Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group- Motivational Interviewing
Arm Type
Experimental
Arm Description
Standard protocols and participation in Motivational Interviews
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Standard protocols
Intervention Type
Other
Intervention Name(s)
Motivational Interviewing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Turkish Version of Champion's Health Belief Model Scale (CHBMS-T)
Description
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.
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.
Title
The Health Belief Model Scale for Cervical Cancer and the Pap Smear Test(HBMSCCPS)
Description
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.
Time Frame
4 Months
10. Eligibility
Sex
Female
Gender Based
Yes
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tuğba ÖZTÜRK, PhD
Phone
+905305279492
Email
tugba.ozturk@ksbu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülşah KÖK, Asst. Prof.
Organizational Affiliation
Department of Obstetrics and Gynecology Nursing, Gulhane Nursing Faculty, Health Sciences University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of the Motivational Interviewing Technique on Breast and Cervical Cancer Screenings
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