Breast CancerNCT06022900
The Effect of Health Education on Breast Cancer
A study testing Online training group and Face-to-face training group in people with Breast Cancer, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study aimed to explore how face-to-face and online health education influenced several factors related to breast cancer, including individuals' self-reported knowledge of breast cancer and mammography, perceptions of the benefits and barriers to mammography, self-confidence in undergoing mammography… 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
- What is being tested?
- Online training group and Face-to-face training group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Mar 2023to 26 May 2023
- 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
- Must voluntarily agree to participate in the research. Must be literate in Turkish. Must be aged between 40 and 69 years. Must identify as a woman. Must have access to the necessary technology for video calls.
Who cannot join
- Any barriers to effective communication. Currently pregnant or in the postpartum period. Currently breastfeeding. Having undergone a mammogram within the past two years. A history of benign breast disease or breast cancer. A family history of breast cancer.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences
Ankara, Ankara, 06000
About this study
Official title: The Impact of Two Distinct Health Education Approaches on Mammography Self-Efficacy, Health Beliefs, and Screening Program Participation: a Randomized Controlled Trial
Objective: This study aimed to explore how face-to-face and online health education influenced several factors related to breast cancer, including individuals' self-reported knowledge of breast cancer and mammography, perceptions of the benefits and barriers to mammography, self-confidence in undergoing mammography, and the rates of participation in screening programs.
Materials and Methods: This research utilized a parallel group design within a single-blind randomized controlled trial framework. A total of 126 healthy participants were recruited, equally divided into three groups of 42, from individuals enrolled at the Toprakkale Family Health Center between January and July 2023, all of whom met the eligibility requirements.In this study, a 10-point Visual Analogue Scale, along with the mammography benefit and barrier perception sub-dimensions from Champion's Health Belief Model Scale and the Mammography Self-Efficacy Scale, were utilized for participants to self-assess their knowledge regarding breast cancer and mammography. While the control group received standard care, the face-to-face education group benefited from health education and informational brochures delivered through home visits, supplemented by a follow-up reminder call. Meanwhile, the online training group received health education and digital brochures via video calls, along with one reminder session. Following a two-month follow-up period, data from the three groups were compared using One-Way Analysis of Variance and the Kruskal-Wallis H test. Multiple comparisons were conducted using Tukey's test and Dunn's test, while Generalized Linear Models were employed for assessing group and time differences.
Read the detailed description
This investigation was structured as a single-blind, parallel-group randomized controlled trial, taking place at the Toprakkale Family Health Center in Osmaniye Province from January to July 2023. A power analysis indicated that at least 96 participants were necessary to achieve a significant effect size (d=0.18) with a 95% power and a 0.05 error margin. The G Power 3.1.9.2 software facilitated these calculations. To mitigate the potential impact of data loss, an additional 30% of participants were included, resulting in a final sample size of 126 individuals, with each of the three groups consisting of 42 participants.
Women aged 40 to 69 who visited the Family Health Center were informed about the study's objectives and subsequently invited to participate. After obtaining consent, the volunteers were screened against the established inclusion criteria. The researchers provided detailed information about the study's goals and handed out Form I to those deemed eligible.
For the purpose of randomization, a block randomization technique was employed, assigning participants to groups based on their order of arrival at the center according to the pre-established randomization list. The control group did not receive any intervention during the study duration. Participants in the online training group were offered digital health education along with an electronic brochure, while those in the face-to-face training group received personalized health education through home visits and a physical training brochure.
Four weeks into the intervention, both the online and face-to-face groups received reminder calls to encourage ongoing engagement. At the conclusion of the eight-week period, all participants completed Form II, allowing for the evaluation of outcomes across all groups.
- Conditions
- Breast Cancer
- Being tested
- Online training group, Face-to-face training group
- Keywords
- Breast Cancer, Mammography, Health Education, Online Education, Home Visit
- Medical subject headings
- Breast Neoplasms, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online training groupBehavioural
online health education with video call
Face-to-face training groupBehavioural
Face-to-face health education with home visit
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | During the study period, this group participated in the standard breast cancer screening program, which is a nationwide health initiative implemented throughout the country to promote early detection and prevention of breast cancer. |
| Online training group | Experimental | Alongside the standard breast cancer screening services, participants in this group were offered comprehensive online health education that emphasized both breast cancer awareness and prevention strategies. Additionally, they received a digital educational brochure designed to enhance their understanding of the disease. Four weeks after their enrollment in the study, participants were contacted via phone to reinforce the significance of regular screenings and to provide them with a summary of essential information regarding the benefits of early detection. Receives: Behavioral: Online training group |
| Face-to-face training group | Experimental | In addition to the standard breast cancer screening services, individuals in this group received tailored in-person health education regarding breast cancer and its prevention through comprehensive home visits, which included a well-designed training brochure. At the conclusion of the fourth week following their enrollment in the study, participants were contacted via phone to emphasize the critical importance of regular screening. During this call, they were provided with a concise summary of key information aimed at reinforcing the benefits of early detection and encouraging ongoing participation in screening programs. Receives: Behavioral: Face-to-face training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Efficacy Scale for Mammography
The scale comprises 10 items, each rated on a 5-point Likert type format. The total score that can be achieved ranges from 10 to 50.
Measured: 60 days
Secondary outcomes (1)
Champion's Health Belief Model Scale
Description: This study focused on two specific sub-dimensions of the scale: the perception of benefits associated with mammography and the perception of barriers to mammography. The benefits sub-dimension comprises five items, while the barriers sub-dimension includes eleven items. In this scale, the perceived benefits of mammography are scored on a scale from 5 to 25 points, whereas the perceived barriers to mammography are scored from 11 to 55 points.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start9 Mar 2023
- Primary completion17 Apr 2023
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment randomised control trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil Özdemir, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- Serpil Ozdemir, PhD, Principal investigator, Sağlık Bilimleri Üniversitesi Gülhane Hemşirelik Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022900
- Sponsor's protocol ID
- BREASTCANCER
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Two Distinct Health Education Approaches on Mammography Self-Efficacy, Health Beliefs, and Screening Program Participation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06022900
- Acronym / sponsor ID
- BREASTCANCER
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Mammography, Health Education, Online Education, Home Visit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 5 Sep 2023 (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.
Objective: This study aimed to explore how face-to-face and online health education influenced several factors related to breast cancer, including individuals' self-reported knowledge of breast cancer and mammography, perceptions of the benefits and barriers to mammography, self-confidence in undergoing mammography, and the rates of participation in screening programs.
Materials and Methods: This research utilized a parallel group design within a single-blind randomized controlled trial framework. A total of 126 healthy participants were recruited, equally divided into three groups of 42, from individuals enrolled at the Toprakkale Family Health Center between January and July 2023, all of whom met the eligibility requirements.In this study, a 10-point Visual Analogue Scale, along with the mammography benefit and barrier perception sub-dimensions from Champion's Health Belief Model Scale and the Mammography Self-Efficacy Scale, were utilized for participants to self-assess their knowledge regarding breast cancer and mammography. While the control group received standard care, the face-to-face education group benefited from health education and informational brochures delivered through home visits, supplemented by a follow-up reminder call. Meanwhile, the online training group received health education and digital brochures via video calls, along with one reminder session. Following a two-month follow-up period, data from the three groups were compared using One-Way Analysis of Variance and the Kruskal-Wallis H test. Multiple comparisons were conducted using Tukey's test and Dunn's test, while Generalized Linear Models were employed for assessing group and time differences.
Detailed description
This investigation was structured as a single-blind, parallel-group randomized controlled trial, taking place at the Toprakkale Family Health Center in Osmaniye Province from January to July 2023. A power analysis indicated that at least 96 participants were necessary to achieve a significant effect size (d=0.18) with a 95% power and a 0.05 error margin. The G Power 3.1.9.2 software facilitated these calculations. To mitigate the potential impact of data loss, an additional 30% of participants were included, resulting in a final sample size of 126 individuals, with each of the three groups consisting of 42 participants.
Women aged 40 to 69 who visited the Family Health Center were informed about the study's objectives and subsequently invited to participate. After obtaining consent, the volunteers were screened against the established inclusion criteria. The researchers provided detailed information about the study's goals and handed out Form I to those deemed eligible.
For the purpose of randomization, a block randomization technique was employed, assigning participants to groups based on their order of arrival at the center according to the pre-established randomization list. The control group did not receive any intervention during the study duration. Participants in the online training group were offered digital health education along with an electronic brochure, while those in the face-to-face training group received personalized health education through home visits and a physical training brochure.
Four weeks into the intervention, both the online and face-to-face groups received reminder calls to encourage ongoing engagement. At the conclusion of the eight-week period, all participants completed Form II, allowing for the evaluation of outcomes across all groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Parallel Assignment randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –During the study period, this group participated in the standard breast cancer screening program, which is a nationwide health initiative implemented throughout the country to promote early detection and prevention of breast cancer. |
| Online training group | Experimental | Behavioral: Online training groupAlongside the standard breast cancer screening services, participants in this group were offered comprehensive online health education that emphasized both breast cancer awareness and prevention strategies. Additionally, they received a digital educational brochure designed to enhance their understanding of the disease. Four weeks after their enrollment in the study, participants were contacted via phone to reinforce the significance of regular screenings and to provide them with a summary of essential information regarding the benefits of early detection. |
| Face-to-face training group | Experimental | Behavioral: Face-to-face training groupIn addition to the standard breast cancer screening services, individuals in this group received tailored in-person health education regarding breast cancer and its prevention through comprehensive home visits, which included a well-designed training brochure. At the conclusion of the fourth week following their enrollment in the study, participants were contacted via phone to emphasize the critical importance of regular screening. During this call, they were provided with a concise summary of key information aimed at reinforcing the benefits of early detection and encouraging ongoing participation in screening programs. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must voluntarily agree to participate in the research. Must be literate in Turkish. Must be aged between 40 and 69 years. Must identify as a woman. Must have access to the necessary technology for video calls.
Key exclusion criteria (1 listed)
- Any barriers to effective communication. Currently pregnant or in the postpartum period. Currently breastfeeding. Having undergone a mammogram within the past two years. A history of benign breast disease or breast cancer. A family history of breast cancer.
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 |
|---|---|---|
| Online training grouponline health education with video call | Behavioural | Online training group |
| Face-to-face training groupFace-to-face health education with home visit | Behavioural | Face-to-face training group |
Primary outcome
Self-Efficacy Scale for Mammography
Time frame: 60 days
The scale comprises 10 items, each rated on a 5-point Likert type format. The total score that can be achieved ranges from 10 to 50.
1 secondary outcome
Champion's Health Belief Model Scale
Time frame: 60 days
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 9 Oct 2024.
- 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. This study is not recruiting at the moment.
Serpil Ozdemir, PhD principal investigator
Sağlık Bilimleri Üniversitesi Gülhane Hemşirelik Fakültesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online training group and Face-to-face training group in people with Breast Cancer, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi 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 1 inclusion and 1 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 9 Oct 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?
Self-Efficacy Scale for Mammography (time frame: 60 days). 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 9 Oct 2024.