Cancer ScreeningBrCaRRPNCT04304404
Risk Reduction Program for Women Having High Risk of Breast Cancer
A study testing Breast Cancer Risk Reduction Program (BrCaRRP) in people with Cancer Screening and Early Detection of Cancer, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
An intervention program involving education, guidance, counseling, case management and surveillance based on the Health Belief Model will be implemented on women with high risk of breast cancer. Read more about this study
- Who is it for?
- Ages 25 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer Screening, Early Detection of Cancer, Breast Cancer
- What is being tested?
- Breast Cancer Risk Reduction Program (BrCaRRP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2018to 1 Sep 2021
- 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 25 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the study
- Being the first degree biological relative of a primary breast cancer patient diagnosed at or before the age of 50
- Aged 25 or older
- No mammography and/or MRI in the last 18 months
- Being literate
Who cannot join
- Having been diagnosed with breast cancer (first degree relative)
- Being pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Risk Reduction Program Applied to Women With High Breast Cancer Risk on Participation in Screening, Health Beliefs and Behavior
An intervention program involving education, guidance, counseling, case management and surveillance based on the Health Belief Model will be implemented on women with high risk of breast cancer. The impact of the breast cancer risk reduction program on participation in breast cancer screenings, health beliefs (health motivation, sensitivity, fear of breast cancer) and behaviors (physical activity, nutrition, health responsibility, genetic counseling) will be evaluated in the study.
Read the detailed description
In women with family history of breast cancer, cancer risk increases at least twice as compared to the population of the same age. The aim of this study is to evaluate the impact of the intervention program based on the Health Belief Model involving education, guidance, counseling, case management and surveillance, on participation in breast cancer screenings, health beliefs and behaviors in women with high risk of breast cancer.
This study protocol describes a randomized controlled trial with parallel group design. First degree biological relatives (mother, daughter, sister) of breast cancer patients who are diagnosed with breast cancer at or under the age of 50 and who apply to the Oncology Department will be randomly assigned to the intervention and control group.
The content of the Breast Cancer Risk Reduction Program created for the Intervention Group was planned according to the Health Belief Model (HBM) theoretical framework. The interventions based on HBM were carried out according to the OMAHA nursing interventions categories used in the field of Public Health Nursing (training, guidance, counseling, case management and surveillance). Breast Cancer Risk Reduction Program (BirCarrePro) is a 12-week program that includes six interviews. The first intervention in this group will begin with a 60-minute face-to-face individual training. After the first face-to-face interview, phone calls will be made in the second, third, sixth, ninth, and twelfth weeks. Pre-tests and post-tests will be completed by the participants via electronic questionnaires. Follow-up questionnaires will be applied by repeating the post-test at the 24th week. In the control group, post-test will be applied 12 weeks after the pre-test, and follow-up questionnaires will be applied 24 weeks after the pre-test.
- Conditions
- Cancer Screening, Early Detection of Cancer, Breast Cancer, Preventive Health Care, Health Behavior
- Being tested
- Breast Cancer Risk Reduction Program (BrCaRRP)
- Medical subject headings
- Breast Neoplasms, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Cancer Risk Reduction Program (BrCaRRP)Behavioural
Also called İntervention Group (BrCaRRP)
Women in the intervention group will complete the pre-tests electronically, and a 12-week intervention program will be implemented. The first meeting will be face-to-face individual training. In this training session, the risk of developing breast cancer will be calculated with each participant using breast cancer risk assessment tools. Modifiable and non-modifiable factors that increase breast cancer risk will be explained. With the participant, it will be decided which of the modifiable risk factors will be improved. Guidance will be given on topics such as genetic counseling, breast cancer screenings, increasing physical activity, healthy nutrition, weight control, smoking and alcohol use. The interventions will continue with phone calls and the 12-week program will be completed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (BrCaRRP) | Experimental | Individual interventions based on the Health Belief Model and the The Health Promotion Model involving education, guidance, counseling, case management and surveillance for women with high breast cancer risk Receives: Behavioral: Breast Cancer Risk Reduction Program (BrCaRRP) |
| Control Group | No intervention | An information note will be given to the control group. The post-tests will be collected at the end of 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Cancer Screening
The primary outcome measure of the study is the participation rate of first degree relatives in breast cancer screenings.
Measured: 12 weeks
Health Belief Model Scale (Susceptibility, Health Motivation sub-factors)
Health Belief Model Scale (Susceptibility, Health Motivation sub-factors)Health Motivation' sub-dimensions of Champion's Health Belief Model Scale will be used in this study. Sensitivity sub-dimension consists of 3 items, and Health Motivation sub-dimension consists of 5 items. In this 5-point Likert type scale, the items are scored as follows: "totally disagree" (1), "disagree" (2), "undecided" (3), "agree" (4), "totally agree" ( 5). All items of this scale are positive. Total score ranges from 8 to 40. Higher scores indicate higher sensitivity and health motivation. The scale contains no reverse items.
Measured: 12 weeks
Breast Cancer Fear Scale
Champion's Breast Cancer Fear Scale consists of two sub-dimensions and eight items. It consists of five items related to thought and three items related to physiological stimulation. In this 5-point Likert type scale, the items are scored as follows: "totally disagree" (1), "disagree" (2), "undecided" (3), "agree" (4), "totally agree" (5). Total score ranges from 8 to 40. As the score increases, the level of breast cancer fear increases. The scale contains no reverse items.
Measured: 12 weeks
Healthy Lifestyle Behaviors Scale II (Health Responsibility, Physical Activity and Nutrition Sub-Scale)
All items of the Healthy Lifestyle Behaviors Scale are positive and are structured as 4-point Likert type items. The scoring is as follows: never (1), sometimes (2), often (3), regularly (4). The scale consists of six sub-dimensions. Only 'Health Responsibility, Physical Activity and Nutrition' sub-dimensions were used in this study. The lowest score that can be obtained from these three sub-dimensions is 26 and the highest score that can be obtained is 104. Higher scores indicate more healthy lifestyle behaviors.
Measured: 12 weeks
International Physical Activity Questionnaire (IPAQ)
IPAQ short form that will be used in this study consists of four sub-dimensions (Severe Physical Activity, Moderate Physical Activity, Mild Physical Activity, and Sitting Times) and seven items. The time spent on mild, moderate and severe activities as well as sitting times and the energy spent in these activities are calculated. The severity, frequency and duration of the activities performed for 10 minutes or longer in the last seven days are evaluated and the activity level is determined as metabolic equivalent (MET). Walking is 3.3 MET, moderate to severe physical activity is 4.0 MET, and severe physical activity is 8.0 MET. The 'MET-min/week' value is obtained by multiplying the MET value of each physical activity level with the days and minutes this physical activity is performed every week. The obtained MET value is classified as severe physical activity (MET>3000), moderate physical activity (MET = 600-3000), and mild physical activity (MET <600).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 Apr 2018
- Primary completion30 May 2021
- Study completion1 Sep 2021
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 Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Habibe ÖZÇELİK, Akdeniz University
- Investigators
- Sebahat GÖZÜM, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304404
- Sponsor's protocol ID
- 68824072019
- Acronym
- BrCaRRP
- Status last verified
- Jul 2023
- First submitted
- 9 Mar 2020
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ozcelik H, Gozum S. The Effect of the Breast Cancer Risk Reduction Program on Women With High Breast Cancer Risk in Terms of Their Participation in Screening and Their Health Beliefs and Behavior: A Study Protocol for a Randomized Controlled Trial. Cancer Nurs. 2024 Nov-Dec 01;47(6):E376-E386. doi: 10.1097/NCC.0000000000001229. Epub 2023 Mar 13.
PubMed 36907899
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Risk Reduction Program Applied to Women With High Breast Cancer Risk on Participation in Screening, Health Beliefs and Behavior
- ClinicalTrials.gov ID
- NCT04304404
- Acronym / sponsor ID
- BrCaRRP / 68824072019
- Conditions
- Cancer Screening, Early Detection of Cancer, Breast Cancer, Preventive Health Care, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 11 Mar 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.
An intervention program involving education, guidance, counseling, case management and surveillance based on the Health Belief Model will be implemented on women with high risk of breast cancer. The impact of the breast cancer risk reduction program on participation in breast cancer screenings, health beliefs (health motivation, sensitivity, fear of breast cancer) and behaviors (physical activity, nutrition, health responsibility, genetic counseling) will be evaluated in the study.
Detailed description
In women with family history of breast cancer, cancer risk increases at least twice as compared to the population of the same age. The aim of this study is to evaluate the impact of the intervention program based on the Health Belief Model involving education, guidance, counseling, case management and surveillance, on participation in breast cancer screenings, health beliefs and behaviors in women with high risk of breast cancer.
This study protocol describes a randomized controlled trial with parallel group design. First degree biological relatives (mother, daughter, sister) of breast cancer patients who are diagnosed with breast cancer at or under the age of 50 and who apply to the Oncology Department will be randomly assigned to the intervention and control group.
The content of the Breast Cancer Risk Reduction Program created for the Intervention Group was planned according to the Health Belief Model (HBM) theoretical framework. The interventions based on HBM were carried out according to the OMAHA nursing interventions categories used in the field of Public Health Nursing (training, guidance, counseling, case management and surveillance). Breast Cancer Risk Reduction Program (BirCarrePro) is a 12-week program that includes six interviews. The first intervention in this group will begin with a 60-minute face-to-face individual training. After the first face-to-face interview, phone calls will be made in the second, third, sixth, ninth, and twelfth weeks. Pre-tests and post-tests will be completed by the participants via electronic questionnaires. Follow-up questionnaires will be applied by repeating the post-test at the 24th week. In the control group, post-test will be applied 12 weeks after the pre-test, and follow-up questionnaires will be applied 24 weeks after the pre-test.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (BrCaRRP) | Experimental | Behavioral: Breast Cancer Risk Reduction Program (BrCaRRP)Individual interventions based on the Health Belief Model and the The Health Promotion Model involving education, guidance, counseling, case management and surveillance for women with high breast cancer risk |
| Control Group | No intervention | –An information note will be given to the control group. The post-tests will be collected at the end of 12 weeks |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteering to participate in the study
- Being the first degree biological relative of a primary breast cancer patient diagnosed at or before the age of 50
- Aged 25 or older
- No mammography and/or MRI in the last 18 months
- Being literate
Key exclusion criteria (2 listed)
- Having been diagnosed with breast cancer (first degree relative)
- Being pregnant or breastfeeding
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 |
|---|---|---|
| Breast Cancer Risk Reduction Program (BrCaRRP)Also: İntervention Group (BrCaRRP)Women in the intervention group will complete the pre-tests electronically, and a 12-week intervention program will be implemented. The first meeting will be face-to-face individual training. In this training session, the risk of developing breast cancer will be calculated with each participant using breast cancer risk assessment tools. Modifiable and non-modifiable factors that increase breast cancer risk will be explained. With the participant, it will be decided which of the modifiable risk factors will be improved. Guidance will be given on topics such as genetic counseling, breast cancer screenings, increasing physical activity, healthy nutrition, weight control, smoking and alcohol use. The interventions will continue with phone calls and the 12-week program will be completed. | Behavioural | Intervention group (BrCaRRP) |
Primary outcome
Breast Cancer Screening
Time frame: 12 weeks
The primary outcome measure of the study is the participation rate of first degree relatives in breast cancer screenings.
Health Belief Model Scale (Susceptibility, Health Motivation sub-factors)
Time frame: 12 weeks
Health Belief Model Scale (Susceptibility, Health Motivation sub-factors)Health Motivation' sub-dimensions of Champion's Health Belief Model Scale will be used in this study. Sensitivity sub-dimension consists of 3 items, and Health Motivation sub-dimension consists of 5 items. In this 5-point Likert type scale, the items are scored as follows: "totally disagree" (1), "disagree" (2), "undecided" (3), "agree" (4), "totally agree" ( 5). All items of this scale are positive. Total score ranges from 8 to 40. Higher scores indicate higher sensitivity and health motivation. The scale contains no reverse items.
Breast Cancer Fear Scale
Time frame: 12 weeks
Champion's Breast Cancer Fear Scale consists of two sub-dimensions and eight items. It consists of five items related to thought and three items related to physiological stimulation. In this 5-point Likert type scale, the items are scored as follows: "totally disagree" (1), "disagree" (2), "undecided" (3), "agree" (4), "totally agree" (5). Total score ranges from 8 to 40. As the score increases, the level of breast cancer fear increases. The scale contains no reverse items.
Healthy Lifestyle Behaviors Scale II (Health Responsibility, Physical Activity and Nutrition Sub-Scale)
Time frame: 12 weeks
All items of the Healthy Lifestyle Behaviors Scale are positive and are structured as 4-point Likert type items. The scoring is as follows: never (1), sometimes (2), often (3), regularly (4). The scale consists of six sub-dimensions. Only 'Health Responsibility, Physical Activity and Nutrition' sub-dimensions were used in this study. The lowest score that can be obtained from these three sub-dimensions is 26 and the highest score that can be obtained is 104. Higher scores indicate more healthy lifestyle behaviors.
International Physical Activity Questionnaire (IPAQ)
Time frame: 12 weeks
IPAQ short form that will be used in this study consists of four sub-dimensions (Severe Physical Activity, Moderate Physical Activity, Mild Physical Activity, and Sitting Times) and seven items. The time spent on mild, moderate and severe activities as well as sitting times and the energy spent in these activities are calculated. The severity, frequency and duration of the activities performed for 10 minutes or longer in the last seven days are evaluated and the activity level is determined as metabolic equivalent (MET). Walking is 3.3 MET, moderate to severe physical activity is 4.0 MET, and severe physical activity is 8.0 MET. The 'MET-min/week' value is obtained by multiplying the MET value of each physical activity level with the days and minutes this physical activity is performed every week. The obtained MET value is classified as severe physical activity (MET>3000), moderate physical activity (MET = 600-3000), and mild physical activity (MET <600).
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 19 Jul 2023.
- Derived from this study: PubMed 36907899Ozcelik H, Gozum S. The Effect of the Breast Cancer Risk Reduction Program on Women With High Breast Cancer Risk in Terms of Their Participation in Screening and Their Health Beliefs and Behavior: A Study Protocol for a Randomized Controlled Trial. Cancer Nurs. 2024 Nov-Dec 01;47(6):E376-E386. doi: 10.1097/NCC.0000000000001229. Epub 2023 Mar 13.
- Individual participant dataSharing planned: Undecided
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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.
Sebahat GÖZÜM study director
Akdeniz 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 Breast Cancer Risk Reduction Program (BrCaRRP) in people with Cancer Screening and Early Detection of Cancer, run by Akdeniz 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 5 inclusion and 2 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 19 Jul 2023. 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?
Breast Cancer Screening (time frame: 12 weeks). The study lists 5 primary outcomes in all. 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 NCT04304404, 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 19 Jul 2023.