Breast Cancer ScreeningNCT07907419
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
A study testing Multicomponent Digital Nudge Intervention Based on the Health Belief Model in people with Breast Cancer Screening and Breast Cancer Awareness, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of a multi-component digital nudge intervention based on the Health Belief Model on breast cancer awareness, health beliefs, and screening behaviors among women aged 40-69. The study is a randomized controlled trial. The sample will consist of 64 women aged 40-69. 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 Screening, Breast Cancer Awareness, Health Belief Model
- What is being tested?
- Multicomponent Digital Nudge Intervention Based on the Health Belief Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participants must volunteer to take part in the study
- Participants must have no barriers to communication
- Participants must not have been diagnosed with breast cancer
- Participants must be women between the ages of 40 and 69
- Participants must be able to use a smartphone
- Participants must be able to use the WhatsApp app
- Participants must not have had a mammogram in the past 2 years
- Participants must not undergo regular mammograms
Who cannot join
- Participants wish to withdraw from the study
- Participants have any barriers to communication
- Participants have been diagnosed with breast cancer
- Participants do not use a smartphone
- Participants do not use the WhatsApp app
- Participants have had a mammogram within the past 2 years
- Participants undergo regular mammograms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of a Multicomponent Digital Nudge Intervention Based on the Health Belief Model on Breast Cancer Awareness, Health Beliefs, and Screening Behaviors
This study aims to evaluate the effect of a multi-component digital nudge intervention based on the Health Belief Model on breast cancer awareness, health beliefs, and screening behaviors among women aged 40-69. The study is a randomized controlled trial. The sample will consist of 64 women aged 40-69. The study will be conducted between December 2026 and December 2027 at the Şükrüpaşa Family Health Center in Erzurum, Turkey. Data will be collected using an Informed Consent Form, the Breast Cancer Awareness Scale, the Health Belief Model Scale for Mammography, and a screening behavior assessment form.
Read the detailed description
This study aims to evaluate the effect of a multi-component digital nudge intervention based on the Health Belief Model on breast cancer awareness, health beliefs, and screening behaviors among women aged 40-69. The study is a randomized controlled trial. The sample will consist of 64 women aged 40-69. The study will be conducted between December 2026 and December 2027 at the Şükrüpaşa Family Health Center in Erzurum, Turkey. Data will be collected using an Informed Consent Form, the Breast Cancer Awareness Scale, the Health Belief Model Scale for Mammography, and a screening behavior assessment form.
Data Collection: Institutional authorization and ethics committee approval have been obtained. Women who meet the inclusion criteria will be invited to participate in the study following an interview at the center. Verbal and written informed consent will be obtained from volunteers who agree to participate. After providing written informed consent and completing the baseline assessment, participants will be randomly assigned to either the intervention or control group in a 1:1 ratio. All groups will be instructed on how to complete the forms. The planned sample size is 64 participants, with 32 women in each group. Participants in the intervention group will receive two WhatsApp messages per week for six weeks, for a total of 12 messages. Messages will be sent on weekdays between 10:00 a.m. and 5:00 p.m. The intervention will target perceived competence, perceived severity, perceived benefits, perceived barriers, and health motivation. The design principles for the nudge messages will be determined using the nudge principles outlined in the MINDSPACE framework. The control group will continue to receive routine primary care services throughout the study period and will not benefit from the digital nudge intervention.
The Breast Cancer Awareness Scale, the Health Belief Model Scale for Mammography, and a screening behavior assessment form will be administered at baseline and immediately following the six-week intervention. At the three-month follow-up, screening intention and behavior-including whether participants underwent a mammogram-will be assessed. Whether participants underwent a mammogram will be determined based on self-reports and verification through health records.
Randomization:
A total of 64 women who meet the inclusion criteria will be assigned to the intervention and control groups in a 1:1 ratio; each group is planned to consist of 32 participants. To ensure the confidentiality of group assignments, sequentially numbered, opaque, and sealed envelopes will be prepared and securely stored by the researcher. After written informed consent is obtained and the baseline assessment is completed, the next envelope in sequence will be opened to determine the participant's group assignment. Due to the nature of the WhatsApp intervention, it is not possible to blind the participants or the researcher administering the intervention to the group assignment. Group information will be coded during statistical analysis to minimize analysis bias.
Data Analysis Statistical analysis of the data will be conducted using a blinded method. The study data will be coded to conceal group information and forwarded to a statistical expert for analysis. Thus, access to group information by both the researcher and the statistical expert will be restricted during the analysis process, thereby maintaining blinding.
Data analysis will be performed using the SPSS (Statistical Package for the Social Sciences) 21.0 software package. Descriptive statistics (mean, standard deviation, frequency, and percentage) will be used in the evaluation of the data. For comparisons between groups, the t-test or the Mann-Whitney U test will be applied; for comparisons within groups, the paired t-test or the Wilcoxon test will be used. The chi-square test will be used to analyze categorical variables, and when necessary, multivariate analyses (regression analysis) will be performed to evaluate relationships between variables.
Ethical Principles of the Study The study will begin after approval from the Ethics Committee of the Faculty of Medicine at Atatürk University and upon receipt of written permission from the center where the study will be conducted. During data collection, patients will be informed about the study; the principles of "Informed Consent," "Respect for Autonomy," and "Protection of Privacy and Confidentiality" will be adhered to. To protect individual rights, the study will adhere to the Declaration of Helsinki throughout its duration. Patients who are willing to participate and meet the inclusion criteria will be enrolled in the study; their verbal and written consent will be obtained prior to data collection.
Limitations and Generalizability of the Study The study is limited to women who presented to the Erzurum Şükrüpaşa Family Health Center, met the sample selection criteria, and agreed to participate. Therefore, the results can only be generalized to patients with characteristics similar to those of this sample group.
- Being tested
- Multicomponent Digital Nudge Intervention Based on the Health Belief Model
- Keywords
- Breast cancer, Health Belief Model, Digital nudge, Breast cancer awareness, Mammography, Screening behavior
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Digital Nudge Intervention Based on the Health Belief ModelBehavioural
Participants in this group will receive a multi-component digital reminder intervention via WhatsApp for six weeks. A total of 12 messages will be sent-two messages per week-on weekdays between 10:00 a.m. and 5:00 p.m. The messages will be designed to address the components of perceived sensitivity, perceived severity, perceived benefits, perceived barriers, and health motivation. In line with the MINDSPACE framework, the message sender will utilize behavioral nudging principles such as salience, emotional appeal, incentives, social norms, ego, commitment, and default options. Assessments will be conducted at baseline, immediately following the intervention, and during the three-month follow-up phase.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent Digital Nudging Intervention Group | Experimental | Multicomponent Digital Nudging Intervention Group Receives: Behavioral: Multicomponent Digital Nudge Intervention Based on the Health Belief Model |
| Control Group | No intervention | Participants in this group will receive routine primary care services, and no WhatsApp-based digital incentive intervention will be administered during the study. Participants will complete the same baseline, post-intervention, and three-month follow-up assessments as the intervention group. Informational brochures will be distributed to the women after the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammography Screening Behavior
It will be assessed whether women have undergone mammography screening. Screening behavior will be classified as "yes" or "no" based on participants' responses to the question: "Have you had a mammogram in the last 3 months?" With participants' consent and the necessary permissions, self-reported mammography uptake will be verified using records from the Cancer Early Diagnosis, Screening and Education Center. In the primary analysis, the proportion of women who underwent mammography during the follow-up period will be compared between the intervention and control groups.
Measured: 3 months after completion of the 6-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Boyraz Şeker, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907419
- Sponsor's protocol ID
- ESRA BOYRAZ ŞEKER
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taniar D, King E, Manger S, Carlisle K. Digital nudging techniques for behaviour change in lifestyle medicine: a scoping review. Front Digit Health. 2026 Jul 30;8:1799205. doi: 10.3389/fdgth.2026.1799205. eCollection 2026.
PubMed 42598347Dolan, P., Hallsworth, M., Halpern, D., King, D., Metcalfe, R., & Vlaev, I. (2012). Influencing behaviour: The mindspace way. Journal of economic psychology, 33(1), 264-277.
Thaler, R. H., & Sunstein, C. R. (2008). Improving decisions about health, wealth and happiness (Vol. 304). Yale University Press New Haven.
Nguyen OT, Kunta AR, Katoju S, Gheytasvand S, Masoumi N, Tavasolian R, Alishahi Tabriz A, Hong YR, Hanna K, Perkins R, Parekh A, Turner K. Electronic Health Record Nudges and Health Care Quality and Outcomes in Primary Care: A Systematic Review. JAMA Netw Open. 2024 Sep 3;7(9):e2432760. doi: 10.1001/jamanetworkopen.2024.32760.
PubMed 39287947Griva F, Anagnostopoulos F, Madoglou S. Mammography screening and the theory of planned behavior: suggestions toward an extended model of prediction. Women Health. 2009 Dec;49(8):662-81. doi: 10.1080/03630240903496010.
PubMed 20183107Wondmu KS, Tessema MT, Degu G, Mihiret GT, Sinshaw MT. Effect of breast cancer education based on the health belief model on knowledge, health belief, and breast self-examination among female students of Debre Markos University, Northwest Ethiopia, in 2021. Front Oncol. 2022 Nov 9;12:1034183. doi: 10.3389/fonc.2022.1034183. eCollection 2022.
PubMed 36439502
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Multicomponent Digital Nudge Intervention Based on the Health Belief Model on Breast Cancer Awareness, Health Beliefs, and Screening Behaviors
- ClinicalTrials.gov ID
- NCT07907419
- Acronym / sponsor ID
- ESRA BOYRAZ ŞEKER
- Keywords
- Breast cancer, Health Belief Model, Digital nudge, Breast cancer awareness, Mammography, Screening behavior
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Oct 2026 (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.
This study aims to evaluate the effect of a multi-component digital nudge intervention based on the Health Belief Model on breast cancer awareness, health beliefs, and screening behaviors among women aged 40-69. The study is a randomized controlled trial. The sample will consist of 64 women aged 40-69. The study will be conducted between December 2026 and December 2027 at the Şükrüpaşa Family Health Center in Erzurum, Turkey. Data will be collected using an Informed Consent Form, the Breast Cancer Awareness Scale, the Health Belief Model Scale for Mammography, and a screening behavior assessment form.
Detailed description
This study aims to evaluate the effect of a multi-component digital nudge intervention based on the Health Belief Model on breast cancer awareness, health beliefs, and screening behaviors among women aged 40-69. The study is a randomized controlled trial. The sample will consist of 64 women aged 40-69. The study will be conducted between December 2026 and December 2027 at the Şükrüpaşa Family Health Center in Erzurum, Turkey. Data will be collected using an Informed Consent Form, the Breast Cancer Awareness Scale, the Health Belief Model Scale for Mammography, and a screening behavior assessment form.
Data Collection: Institutional authorization and ethics committee approval have been obtained. Women who meet the inclusion criteria will be invited to participate in the study following an interview at the center. Verbal and written informed consent will be obtained from volunteers who agree to participate. After providing written informed consent and completing the baseline assessment, participants will be randomly assigned to either the intervention or control group in a 1:1 ratio. All groups will be instructed on how to complete the forms. The planned sample size is 64 participants, with 32 women in each group. Participants in the intervention group will receive two WhatsApp messages per week for six weeks, for a total of 12 messages. Messages will be sent on weekdays between 10:00 a.m. and 5:00 p.m. The intervention will target perceived competence, perceived severity, perceived benefits, perceived barriers, and health motivation. The design principles for the nudge messages will be determined using the nudge principles outlined in the MINDSPACE framework. The control group will continue to receive routine primary care services throughout the study period and will not benefit from the digital nudge intervention.
The Breast Cancer Awareness Scale, the Health Belief Model Scale for Mammography, and a screening behavior assessment form will be administered at baseline and immediately following the six-week intervention. At the three-month follow-up, screening intention and behavior-including whether participants underwent a mammogram-will be assessed. Whether participants underwent a mammogram will be determined based on self-reports and verification through health records.
Randomization:
A total of 64 women who meet the inclusion criteria will be assigned to the intervention and control groups in a 1:1 ratio; each group is planned to consist of 32 participants. To ensure the confidentiality of group assignments, sequentially numbered, opaque, and sealed envelopes will be prepared and securely stored by the researcher. After written informed consent is obtained and the baseline assessment is completed, the next envelope in sequence will be opened to determine the participant's group assignment. Due to the nature of the WhatsApp intervention, it is not possible to blind the participants or the researcher administering the intervention to the group assignment. Group information will be coded during statistical analysis to minimize analysis bias.
Data Analysis Statistical analysis of the data will be conducted using a blinded method. The study data will be coded to conceal group information and forwarded to a statistical expert for analysis. Thus, access to group information by both the researcher and the statistical expert will be restricted during the analysis process, thereby maintaining blinding.
Data analysis will be performed using the SPSS (Statistical Package for the Social Sciences) 21.0 software package. Descriptive statistics (mean, standard deviation, frequency, and percentage) will be used in the evaluation of the data. For comparisons between groups, the t-test or the Mann-Whitney U test will be applied; for comparisons within groups, the paired t-test or the Wilcoxon test will be used. The chi-square test will be used to analyze categorical variables, and when necessary, multivariate analyses (regression analysis) will be performed to evaluate relationships between variables.
Ethical Principles of the Study The study will begin after approval from the Ethics Committee of the Faculty of Medicine at Atatürk University and upon receipt of written permission from the center where the study will be conducted. During data collection, patients will be informed about the study; the principles of "Informed Consent," "Respect for Autonomy," and "Protection of Privacy and Confidentiality" will be adhered to. To protect individual rights, the study will adhere to the Declaration of Helsinki throughout its duration. Patients who are willing to participate and meet the inclusion criteria will be enrolled in the study; their verbal and written consent will be obtained prior to data collection.
Limitations and Generalizability of the Study The study is limited to women who presented to the Erzurum Şükrüpaşa Family Health Center, met the sample selection criteria, and agreed to participate. Therefore, the results can only be generalized to patients with characteristics similar to those of this sample group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Digital Nudging Intervention Group | Experimental | Behavioral: Multicomponent Digital Nudge Intervention Based on the Health Belief ModelMulticomponent Digital Nudging Intervention Group |
| Control Group | No intervention | –Participants in this group will receive routine primary care services, and no WhatsApp-based digital incentive intervention will be administered during the study. Participants will complete the same baseline, post-intervention, and three-month follow-up assessments as the intervention group. Informational brochures will be distributed to the women after the study. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must volunteer to take part in the study
- Participants must have no barriers to communication
- Participants must not have been diagnosed with breast cancer
- Participants must be women between the ages of 40 and 69
- Participants must be able to use a smartphone
Key exclusion criteria (7 listed)
- Participants wish to withdraw from the study
- Participants have any barriers to communication
- Participants have been diagnosed with breast cancer
- Participants do not use a smartphone
- Participants do not use the WhatsApp app
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 |
|---|---|---|
| Multicomponent Digital Nudge Intervention Based on the Health Belief ModelParticipants in this group will receive a multi-component digital reminder intervention via WhatsApp for six weeks. A total of 12 messages will be sent-two messages per week-on weekdays between 10:00 a.m. and 5:00 p.m. The messages will be designed to address the components of perceived sensitivity, perceived severity, perceived benefits, perceived barriers, and health motivation. In line with the MINDSPACE framework, the message sender will utilize behavioral nudging principles such as salience, emotional appeal, incentives, social norms, ego, commitment, and default options. Assessments will be conducted at baseline, immediately following the intervention, and during the three-month follow-up phase. | Behavioural | Multicomponent Digital Nudging Intervention Group |
Primary outcome
Mammography Screening Behavior
Time frame: 3 months after completion of the 6-week intervention.
It will be assessed whether women have undergone mammography screening. Screening behavior will be classified as "yes" or "no" based on participants' responses to the question: "Have you had a mammogram in the last 3 months?" With participants' consent and the necessary permissions, self-reported mammography uptake will be verified using records from the Cancer Early Diagnosis, Screening and Education Center. In the primary analysis, the proportion of women who underwent mammography during the follow-up period will be compared between the intervention and control groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 42598347Taniar D, King E, Manger S, Carlisle K. Digital nudging techniques for behaviour change in lifestyle medicine: a scoping review. Front Digit Health. 2026 Jul 30;8:1799205. doi: 10.3389/fdgth.2026.1799205. eCollection 2026.
- BackgroundDolan, P., Hallsworth, M., Halpern, D., King, D., Metcalfe, R., & Vlaev, I. (2012). Influencing behaviour: The mindspace way. Journal of economic psychology, 33(1), 264-277.
- BackgroundThaler, R. H., & Sunstein, C. R. (2008). Improving decisions about health, wealth and happiness (Vol. 304). Yale University Press New Haven.
- Background: PubMed 39287947Nguyen OT, Kunta AR, Katoju S, Gheytasvand S, Masoumi N, Tavasolian R, Alishahi Tabriz A, Hong YR, Hanna K, Perkins R, Parekh A, Turner K. Electronic Health Record Nudges and Health Care Quality and Outcomes in Primary Care: A Systematic Review. JAMA Netw Open. 2024 Sep 3;7(9):e2432760. doi: 10.1001/jamanetworkopen.2024.32760.
- Background: PubMed 20183107Griva F, Anagnostopoulos F, Madoglou S. Mammography screening and the theory of planned behavior: suggestions toward an extended model of prediction. Women Health. 2009 Dec;49(8):662-81. doi: 10.1080/03630240903496010.
- Background: PubMed 36439502Wondmu KS, Tessema MT, Degu G, Mihiret GT, Sinshaw MT. Effect of breast cancer education based on the health belief model on knowledge, health belief, and breast self-examination among female students of Debre Markos University, Northwest Ethiopia, in 2021. Front Oncol. 2022 Nov 9;12:1034183. doi: 10.3389/fonc.2022.1034183. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Digital Nudge Intervention Based on the Health Belief Model in people with Breast Cancer Screening and Breast Cancer Awareness, run by Ataturk University 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 7 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: opening soon, as of the sponsor's last update on 2 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esra BOYRAZ ŞEKER, PhD Student (+905434606138, esra.boyraz.seker23@ogr.atauni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mammography Screening Behavior (time frame: 3 months after completion of the 6-week intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07907419, which also lists 6 linked publications.
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 2 Nov 2026.