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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
Istanbul Saglik Bilimleri University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Menopause

Eligibility Criteria

undefined - 69 Years (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    April 23, 2022
    Last Updated
    April 29, 2022
    Sponsor
    Istanbul Saglik Bilimleri University
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    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

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    The Effect of the Motivational Interviewing Technique on Breast and Cervical Cancer Screenings

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