- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05418985
The Effect of Monthly Text Message Reminder After Training on Beliefs and Practice Behaviors Regarding Women's Breast Self Examination: Randomized Controlled Study
June 10, 2022 updated by: Deniz Akyıldız
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 Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
83
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Deniz AKYILDIZ, PhD
- Phone Number: 05069851358
- Email: denizbtm@gmail.com
Study Contact Backup
- Name: Deniz AKYILDIZ, PhD
- Email: denizbtm@gmail.com
Study Locations
-
-
-
Kahramanmaras, Turkey, 4600
- Recruiting
- Kahramanmaras Sutcu Imam University
-
Contact:
- Deniz AKYILDIZ
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
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.
|
Monthly reminder message about breast self-exam.
|
No Intervention: Control droup
Women in this group were given training on breast self-examination (BSE).
No intervention was made afterwards.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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3 months after BSE education
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behaviors of women performing breast self-examination
Time Frame: 3 months after BSE education
|
The other main outcome of the study was women performing breast self-examination measured with the BSE follow-up form.
|
3 months after BSE education
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hilal ALKAN, Student, Kahramanmaras Sutcu Imam University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
September 1, 2021
Study Completion (Anticipated)
July 30, 2022
Study Registration Dates
First Submitted
June 10, 2022
First Submitted That Met QC Criteria
June 10, 2022
First Posted (Actual)
June 15, 2022
Study Record Updates
Last Update Posted (Actual)
June 15, 2022
Last Update Submitted That Met QC Criteria
June 10, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Text Message Reminder BSE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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