NCT06395896

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 28, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

May 13, 2024

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2024

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

18 days

First QC Date

April 28, 2024

Last Update Submit

July 9, 2024

Conditions

Keywords

Breast NeoplasmsHealth Belief ModelMammography

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Breast Cancer Prevention Journey Program Group

EXPERIMENTAL

Participants will first receive structured "The Fighting Breast Cancer" training based on the Health Belief Model. Then they will be taken to mammography screening with a free transportation service and will be screened for cancer.

Other: Breast Cancer Prevention Journey Program Group

Routine Cancer Screening Program Group

OTHER

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.

Other: Routine Cancer Screening Program Group

Interventions

The researcher will invite individuals to the study at Necip Fazıl 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.

Breast Cancer Prevention Journey 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.

Routine Cancer Screening Program Group

Eligibility Criteria

Age40 Years - 69 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being a woman between the ages of 40-69
  • Having never had a mammogram before

You may not qualify if:

  • Being diagnosed with breast cancer
  • Having had a breast operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lokman Hekim Üniversitesi

Ankara, Çankaya, 06510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nurbanu Odacı, Master

    Lokman Hekim Universty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The statistical evaluation will be performed by a person other than the researchers and the experimental and control groups will be anonymized.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: There are two groups: experimental group and control group.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 28, 2024

First Posted

May 2, 2024

Study Start

May 13, 2024

Primary Completion

May 31, 2024

Study Completion

June 28, 2024

Last Updated

July 10, 2024

Record last verified: 2024-07

Locations