Breast CancercancerNCT04225741
Theory-based Training to Promote Breast Cancer Screening
A study testing Training group in people with Breast Cancer and Breast Cancer Female, run by Inonu University.
Trial summary
BACKGROUND: Breast cancer worries are important determinants in relation to behavior favoring breast cancer screening. OBJECTIVE: To determine the effect of theory-based training to promote breast cancer screening among women with high and low levels of breast cancer worries. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Breast Cancer Female
- What is being tested?
- Training group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- No sites listed yet
- Study dates
- 22 Jan 2015to 30 Aug 2017
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participants included did not have any diagnosis of breast cancer, had not been performing breast self-examination regularly (every month), had not previously had a mammogram, had not previously had a clinical breast examination, were not pregnant or breastfeeding and were literate.
Who cannot join
- Missing data collection forms.
About this study
Official title: Theory-based Training to Promote Breast Cancer Screening Among Women With Breast Cancer Worries: Randomized Controlled Trial
BACKGROUND: Breast cancer worries are important determinants in relation to behavior favoring breast cancer screening.
OBJECTIVE: To determine the effect of theory-based training to promote breast cancer screening among women with high and low levels of breast cancer worries.
Read more
DESIGN AND SETTING: Randomized controlled trial, conducted in two family health centers.
METHODS: In total, 285 women were recruited. Women with low levels of breast cancer worries were included in the first intervention group (112 women) and the first control group (112 women), while women with high levels of breast cancer worries were included in the second intervention group (37 women) and the second control group (43 women). Theory-based training to promote breast cancer screening was given to intervention groups. The women's willingness to undergo breast cancer screening and breast cancer worry scores were evaluated at 1, 3 and 6 months.
Read the detailed description
Breast cancer is the most frequent type of cancer and the most common cause of cancer death among gynecological cancers. One in every four women with cancer in the world has breast cancer. The International Cancer Agency reported that there were around 2,088,849 new cases and 626,679 deaths due to breast cancer worldwide in 2018. The incidence of breast cancer is higher in developed countries than in developing countries, but the numbers of deaths due to breast cancer are lower in developed countries than in developing countries.
It is known that breast self-examination, clinical breast examination and mammography play an important role in making an early diagnosis of breast cancer. The uptake rate for mammography performed on a regular basis is low because this is an expensive method, considering that not all individuals have health insurance and public funding is inadequate, especially in developing countries. Hence, breast self-examination (which has no cost) and clinical breast examination (which only has low cost) remain important diagnostic methods. Moreover, during clinical breast examination, healthcare professionals have the opportunity to advise on breast cancer, risk factors, prevention methods and screening methods.
- Conditions
- Breast Cancer, Breast Cancer Female
- Being tested
- Training group
- Keywords
- Mammography, Breast self-examination, Early diagnosis
- Medical subject headings
- Breast Neoplasms, Breast Self-Examination, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training groupBehavioural
The single-session training lasted for approximately 40-45 minutes and was conducted in the training room of Sıtmapınarı family health center, as a suitable environment. The health belief model predicts the determinants of preventive health behaviors and explains inadequate participation in disease prevention and screening programs. Furthermore, this model not only explains behavior regarding screening, but also evaluates the cognitive factors that facilitate health-promoting behaviors.
| Study group | Role | What they receive |
|---|---|---|
| training group | Experimental | The single-session training lasted for approximately 40-45 minutes and was conducted in the training room of Sıtmapınarı family health center, as a suitable environment. The health belief model predicts the determinants of preventive health behaviors and explains inadequate participation in disease prevention and screening programs.22,23 Furthermore, this model not only explains behavior regarding screening, but also evaluates the cognitive factors that facilitate health-promoting behaviors.22-24 Receives: Behavioral: Training group |
| Control Group | No intervention | None of the interventions described above were applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Cancer Worry Scale
Breast Cancer Worry Scale: Lerman et al. developed this three-item scale to measure breast cancer worry levels and their effect on daily activities and mood. Lerman subsequently modified the scale, such that it was extended from breast cancer to general cancer and its number of questions was increased to six. Lerman's six-item cancer worry scale was then modified by Timur Taşhan et al. to measure breast cancer worries alone, and a Turkish validity and reliability study on the BCWS was conducted. Thus, overall, the lowest score that can be obtained is 0, and the highest is 24. A total score of less than 12 denotes a low level of worry regarding cancer, and a total score ≥ 12 indicates a high level of worry.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start22 Jan 2015
- Primary completion11 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gnacar, Inonu University
- Investigators
- Gülçin NACAR, Msc, Study director, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225741
- Sponsor's protocol ID
- gulcin
- Acronym
- cancer
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2020
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Timur Tashan S, Ucar T, Aksoy Derya Y, Nacar G, Erci B. Validity and Reliability of the Turkish Version of the Modified Breast Cancer Worry Scale. Iran J Public Health. 2018 Nov;47(11):1681-1687.
PubMed 30581784
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theory-based Training to Promote Breast Cancer Screening Among Women With Breast Cancer Worries: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04225741
- Acronym / sponsor ID
- cancer / gulcin
- Conditions
- Breast Cancer, Breast Cancer Female
- Keywords
- Mammography, Breast self-examination, Early diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 22 Jan 2015 (actual)
- Primary completion
- 11 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 13 Jan 2020 (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.
BACKGROUND: Breast cancer worries are important determinants in relation to behavior favoring breast cancer screening.
OBJECTIVE: To determine the effect of theory-based training to promote breast cancer screening among women with high and low levels of breast cancer worries.
DESIGN AND SETTING: Randomized controlled trial, conducted in two family health centers.
METHODS: In total, 285 women were recruited. Women with low levels of breast cancer worries were included in the first intervention group (112 women) and the first control group (112 women), while women with high levels of breast cancer worries were included in the second intervention group (37 women) and the second control group (43 women). Theory-based training to promote breast cancer screening was given to intervention groups. The women's willingness to undergo breast cancer screening and breast cancer worry scores were evaluated at 1, 3 and 6 months.
Detailed description
Breast cancer is the most frequent type of cancer and the most common cause of cancer death among gynecological cancers. One in every four women with cancer in the world has breast cancer. The International Cancer Agency reported that there were around 2,088,849 new cases and 626,679 deaths due to breast cancer worldwide in 2018. The incidence of breast cancer is higher in developed countries than in developing countries, but the numbers of deaths due to breast cancer are lower in developed countries than in developing countries.
It is known that breast self-examination, clinical breast examination and mammography play an important role in making an early diagnosis of breast cancer. The uptake rate for mammography performed on a regular basis is low because this is an expensive method, considering that not all individuals have health insurance and public funding is inadequate, especially in developing countries. Hence, breast self-examination (which has no cost) and clinical breast examination (which only has low cost) remain important diagnostic methods. Moreover, during clinical breast examination, healthcare professionals have the opportunity to advise on breast cancer, risk factors, prevention methods and screening methods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training group | Experimental | Behavioral: Training groupThe single-session training lasted for approximately 40-45 minutes and was conducted in the training room of Sıtmapınarı family health center, as a suitable environment. The health belief model predicts the determinants of preventive health behaviors and explains inadequate participation in disease prevention and screening programs.22,23 Furthermore, this model not only explains behavior regarding screening, but also evaluates the cognitive factors that facilitate health-promoting behaviors.22-24 |
| Control Group | No intervention | –None of the interventions described above were applied to the control group. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The participants included did not have any diagnosis of breast cancer, had not been performing breast self-examination regularly (every month), had not previously had a mammogram, had not previously had a clinical breast examination, were not pregnant or breastfeeding and were literate.
Key exclusion criteria (1 listed)
- Missing data collection forms.
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 |
|---|---|---|
| Training groupThe single-session training lasted for approximately 40-45 minutes and was conducted in the training room of Sıtmapınarı family health center, as a suitable environment. The health belief model predicts the determinants of preventive health behaviors and explains inadequate participation in disease prevention and screening programs. Furthermore, this model not only explains behavior regarding screening, but also evaluates the cognitive factors that facilitate health-promoting behaviors. | Behavioural | training group |
Primary outcome
Breast Cancer Worry Scale
Time frame: 6 months
Breast Cancer Worry Scale: Lerman et al. developed this three-item scale to measure breast cancer worry levels and their effect on daily activities and mood. Lerman subsequently modified the scale, such that it was extended from breast cancer to general cancer and its number of questions was increased to six. Lerman's six-item cancer worry scale was then modified by Timur Taşhan et al. to measure breast cancer worries alone, and a Turkish validity and reliability study on the BCWS was conducted. Thus, overall, the lowest score that can be obtained is 0, and the highest is 24. A total score of less than 12 denotes a low level of worry regarding cancer, and a total score ≥ 12 indicates a high level of worry.
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 14 Jan 2020.
- Results publication: PubMed 30581784Timur Tashan S, Ucar T, Aksoy Derya Y, Nacar G, Erci B. Validity and Reliability of the Turkish Version of the Modified Breast Cancer Worry Scale. Iran J Public Health. 2018 Nov;47(11):1681-1687.
- Validity and Reliability of the Turkish Version of the Modified Breast Cancer Worry Scale.Link provided by the sponsor.
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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.
Gülçin NACAR, Msc study director
Inonu University
Questions about this trial
What is this clinical trial studying?
A study testing Training group in people with Breast Cancer and Breast Cancer Female, run by Inonu University.
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 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Breast Cancer Worry Scale (time frame: 6 months). 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 NCT04225741, which also lists 1 linked publication.
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 14 Jan 2020.