Women's Breast Self Examination BeliefsNCT05418985
The Effect of Monthly Text Message Reminder After Training on Beliefs and Practice Behaviors Regarding Women's Breast Self Examination: Randomized Controlled Study
A study testing Monthly reminder message about breast self-exam. in people with Women's Breast Self Examination Beliefs and Women's Breast Self Examination Practice, run by Deniz Akyıldız at 1 site in Turkey (Türkiye).
Trial summary
A randomized control trial was made to examine the effects of of monthly text message reminder after training on beliefs and practice behaviors regarding women's breast self examination. Read more about this study
- Who is it for?
- Ages 20 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women's Breast Self Examination Beliefs, Women's Breast Self Examination Practice
- What is being tested?
- Monthly reminder message about breast self-exam.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 30 Jul 2022
- 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 20 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 20-69,
- Able to speak and understand Turkish,
- At least primary school graduate,
- Not in pregnancy or postpartum period,
- Not in the breastfeeding process,
- Menarche,
- No current diagnosis of breast cancer,
- No breast disease that may affect the examination finding.
Who cannot join
- Those who did not complete the training on BSE,
- Those who want to leave the research,
- Those who had pregnancy during the research and
- Those who do not fill in the data forms sent to their e-mail addresses despite being reminded by message three times.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University
Kahramanmaraş, Turkey, 4600
About this study
A randomized control trial was made to examine the effects of of monthly text message reminder after training on beliefs and practice behaviors regarding women's breast self examination.
- Being tested
- Monthly reminder message about breast self-exam.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monthly reminder message about breast self-exam.Behavioural
Monthly reminder message about breast self-exam.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Women in this group were given training on breast self-examination (BSE). In the three-month period following the training, a reminder text message was sent to mobile phones by the researcher to perform BSE. The text message was sent to women with regular and regular menstrual cycles on the seventh day after the bleeding ceased, and on the first day of the month to menopausal women with irregular menstrual cycles. Receives: Behavioral: Monthly reminder message about breast self-exam. |
| Control droup | No intervention | Women in this group were given training on breast self-examination (BSE). No intervention was made afterwards. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Women's beliefs about breast self-exam levet (mean ± SD)
The primary outcome of this study was the mean beliefs about breast self-exam levet (mean ± SD) of the womens at 3 months after BSE education. Women beliefs about breast self-exam level was assessed using Champion's Health Belief Model Scale.
Measured: 3 months after BSE education
Secondary outcomes (1)
Behaviors of women performing breast self-examination
The other main outcome of the study was women performing breast self-examination measured with the BSE follow-up form.
Measured: 3 months after BSE education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Sep 2021
- Primary completion15 Dec 2021
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women's Breast Self Examination BeliefsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deniz Akyıldız
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Deniz Akyıldız, Kahramanmaras Sutcu Imam University
- Investigators
- Hilal ALKAN, Student, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418985
- Sponsor's protocol ID
- Text Message Reminder BSE
- Status last verified
- Sep 2021
- First submitted
- 10 Jun 2022
- Last updated
- 27 Sep 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 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Monthly Text Message Reminder After Training on Beliefs and Practice Behaviors Regarding Women's Breast Self Examination: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05418985
- Acronym / sponsor ID
- Text Message Reminder BSE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Deniz AkyıldızUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 15 Jun 2022 (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.
A randomized control trial was made to examine the effects of of monthly text message reminder after training on beliefs and practice behaviors regarding women's breast self examination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Monthly reminder message about breast self-exam.Women in this group were given training on breast self-examination (BSE). In the three-month period following the training, a reminder text message was sent to mobile phones by the researcher to perform BSE. The text message was sent to women with regular and regular menstrual cycles on the seventh day after the bleeding ceased, and on the first day of the month to menopausal women with irregular menstrual cycles. |
| Control droup | No intervention | –Women in this group were given training on breast self-examination (BSE). No intervention was made afterwards. |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Between the ages of 20-69,
- Able to speak and understand Turkish,
- At least primary school graduate,
- Not in pregnancy or postpartum period,
- Not in the breastfeeding process,
Key exclusion criteria (4 listed)
- Those who did not complete the training on BSE,
- Those who want to leave the research,
- Those who had pregnancy during the research and
- Those who do not fill in the data forms sent to their e-mail addresses despite being reminded by message three times.
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 |
|---|---|---|
| Monthly reminder message about breast self-exam.Monthly reminder message about breast self-exam. | Behavioural | Intervention group |
Primary outcome
Women's beliefs about breast self-exam levet (mean ± SD)
Time frame: 3 months after BSE education
The primary outcome of this study was the mean beliefs about breast self-exam levet (mean ± SD) of the womens at 3 months after BSE education. Women beliefs about breast self-exam level was assessed using Champion's Health Belief Model Scale.
1 secondary outcome
Behaviors of women performing breast self-examination
Time frame: 3 months after BSE education
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 27 Sep 2024.
Related trials for Women's Breast Self Examination Beliefs
Active, not recruitingObservational study
Health Belief Model-Based Survey on Breast Self-Examination Awareness and Practice Among Community-Dwelling Middle-Aged and Older Women
Breast Neoplasms, Breast Self-Examination
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.
Hilal ALKAN, Student principal investigator
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monthly reminder message about breast self-exam. in people with Women's Breast Self Examination Beliefs and Women's Breast Self Examination Practice, run by Deniz Akyıldız 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 8 inclusion and 4 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 27 Sep 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?
Women's beliefs about breast self-exam levet (mean ± SD) (time frame: 3 months after BSE education). 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 27 Sep 2024.