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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06395896
Other study ID # LokmanHekimU-Hem-NO-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 20, 2024
Est. completion date June 4, 2024

Study information

Verified date May 2024
Source Lokman Hekim Üniversitesi
Contact Nurbanu Odaci, Master
Phone +905444083222
Email nur_banu_odaci@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this quasi-experimental study is to determine the effect of the "Breast Cancer Prevention Journey Program" on health beliefs about breast cancer in women over 40 years of age who have never had a mammogram before. The research aims to answer the following basic questions: -Do women who participated in the "Breast Cancer Prevention Journey Program" have different health beliefs about breast cancer than women who did not participate in the program? The researchers will compare the program with routine care to see if the "Breast Cancer Prevention Journey Program" works. The study will be conducted in a quasi-experimental design with a pre-test post-test control group. Participants in the experimental group will first participate in the "The fight against breast cancer" training structured according to the Health Belief Model. One week after the training, the participants in the experimental group will be taken to mammography screening with free shuttles. Participants in the control group will not receive any additional intervention. This group will only receive routine intervention within the scope of the breast cancer screening program conducted by the Ministry of Health.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date June 4, 2024
Est. primary completion date June 4, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 69 Years
Eligibility Inclusion Criteria: - Being a woman between the ages of 40-69 - Having never had a mammogram before Exclusion Criteria: - Being diagnosed with breast cancer - Having had a breast operation

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Breast Cancer Prevention Journey Program Group
The researcher will invite individuals to the study at Necip Fazil Family Center and conduct a pre-test application. The day and time for the "Fight Against Breast Cancer" training, which is structured based on the Health Belief Model prepared by the researchers, will be determined and announced to the participants. The training will be held in a single session of 45-60 minutes. Slide presentation and a breast model showing the symptoms of breast cancer will be used as training materials. At the end of the training, it will be announced that free shuttle service will be provided for mammography screening and individuals will be invited to screening. On the specified day and time, participants will be taken to the "Cancer Early Diagnosis, Screening and Education Center (KETEM)" in Mamak and mammography screening will be performed. After the screening, a post-test will be performed.
Routine Cancer Screening Program Group
Participants in the control group will not receive any additional intervention. This group will only receive routine intervention within the scope of the breast cancer screening program conducted by the Ministry of Health. Health Ministry of Türkiye offers free mammography screening for breast cancer to women over the age of 40. In this context, women are called to the centers by phone and mammography screening is performed free of charge.

Locations

Country Name City State
Turkey Lokman Hekim Üniversitesi Ankara Çankaya

Sponsors (2)

Lead Sponsor Collaborator
Nurbanu Odaci The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Champion's Health Belief Model Scale in Breast Cancer Screening This scale was developed to assess women's breast cancer beliefs (1984) and adapted into Turkish in 2004 (2004). It has a total of 52 items. It is a 5-point Likert-type scale. No single total score is obtained from the scale. The 8 sub-dimensions of the scale and the minimum and maximum scores that can be obtained are as follows; "Perception of sensitivity (min:3; max:15)", "Perception of severity (min:6; max:30)", "Perception of health motivation (min:5; max:25)", "Perception of benefit of breast self-examination (BSE) (min: 4; max:20)", 'Perception of benefit of breast self-examination (CBM) (min:10; max:50)', 'Barriers to CBM (min:8; max:40)', 'Perception of benefit of mammography (min:5; max:25)' and 'Barriers to mammography (min:11; max:55)'. Scale subscale scores are calculated by summing the scores. An increase in score is associated with a positive attitude in all sub-dimensions except the barrier sub-dimension. The Cronbach's Alpha value of the scale is between 0.69 and 0.83. two week
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