Breast Cancer FemaleNCT06395896
The Effect of Breast Cancer Prevention Journey Program
A study testing Breast Cancer Prevention Journey Program Group and Routine Cancer Screening Program Group in people with Breast Cancer Female, run by Nurbanu Odacı at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Breast Cancer Prevention Journey Program Group and Routine Cancer Screening Program Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 May 2024to 28 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a woman between the ages of 40-69
- Having never had a mammogram before
Who cannot join
- Being diagnosed with breast cancer
- Having had a breast operation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Lokman Hekim Üniversitesi
Ankara, Çankaya, 06510
About this study
Official title: The Effect of Breast Cancer Prevention Journey Program on Women's Health Beliefs Towards Breast Cancer: Quasi Experimental Study
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.
Read more
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.
- Conditions
- Breast Cancer Female
- Being tested
- Breast Cancer Prevention Journey Program Group, Routine Cancer Screening Program Group
- Keywords
- Breast Neoplasms, Health Belief Model, Mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Cancer Prevention Journey Program GroupOther
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.
Routine Cancer Screening Program GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine Cancer Screening Program Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start13 May 2024
- Primary completion31 May 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups: experimental group and control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nurbanu Odacı
- Sponsor type
- Other government
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, Nurbanu Odacı, Lokman Hekim University
- Investigators
- Nurbanu Odacı, Master, Principal investigator, Lokman Hekim Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395896
- Sponsor's protocol ID
- LokmanHekimU-Hem-NO-01
- Status last verified
- Jul 2024
- First submitted
- 28 Apr 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breast Cancer Prevention Journey Program on Women's Health Beliefs Towards Breast Cancer: Quasi Experimental Study
- ClinicalTrials.gov ID
- NCT06395896
- Acronym / sponsor ID
- LokmanHekimU-Hem-NO-01
- Conditions
- Breast Cancer Female
- Keywords
- Breast Neoplasms, Health Belief Model, Mammography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Nurbanu OdacıOther government
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 13 May 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There are two groups: experimental group and control group.
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Prevention Journey Program Group | Experimental | Other: Breast Cancer Prevention Journey Program GroupParticipants 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. |
| Routine Cancer Screening Program Group | Other | Other: Routine Cancer Screening Program GroupParticipants 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. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being a woman between the ages of 40-69
- Having never had a mammogram before
Key exclusion criteria (2 listed)
- Being diagnosed with breast cancer
- Having had a breast operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast Cancer Prevention Journey Program GroupThe 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. | Other | Breast Cancer Prevention Journey Program Group |
| Routine Cancer Screening Program GroupParticipants 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. | Other | Routine Cancer Screening Program Group |
Primary outcome
Champion's Health Belief Model Scale in Breast Cancer Screening
Time frame: two week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurbanu Odacı, Master principal investigator
Lokman Hekim Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Cancer Prevention Journey Program Group and Routine Cancer Screening Program Group in people with Breast Cancer Female, run by Nurbanu Odacı at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Champion's Health Belief Model Scale in Breast Cancer Screening (time frame: two week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.