NCT05353387

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

April 30, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

May 5, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

April 23, 2022

Last Update Submit

April 29, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    4 Months

Study Arms (2)

Intervention Group- Motivational Interviewing

EXPERIMENTAL

Standard protocols and participation in Motivational Interviews

Other: Motivational Interviewing

Control Group

NO INTERVENTION

Standard protocols

Interventions

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.

Intervention Group- Motivational Interviewing

Eligibility Criteria

AgeUp to 69 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Having been diagnosed with any cancer,
  • Inability to communicate,
  • Failure to continue the phases of the study for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical NeoplasmsBreast Neoplasms

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Gülşah KÖK, Asst. Prof.

    Department of Obstetrics and Gynecology Nursing, Gulhane Nursing Faculty, Health Sciences University

    STUDY DIRECTOR

Central Study Contacts

Tuğba ÖZTÜRK, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2022

First Posted

April 29, 2022

Study Start

April 30, 2022

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

May 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share