Breast Cancer PreventionPREVCARNCT07016711
Adherence to the Mediterranean Diet Among Women Attending Mammographic Screening
An observational study of Breast Cancer Prevention, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
The PREVCAR study is a cross-sectional investigation aimed at evaluating dietary habits among women undergoing breast cancer screening. Specifically, the study focuses on adherence to the Mediterranean diet, a dietary pattern recognized for its potential protective role against chronic diseases, including breast… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Prevention
- What is being tested?
- Lifestyle and Nutrition Promotion
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 35,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to May 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 18 years and older
- Women only
- Adult, Older adult
Study population: The study will focus on women aged 18 and older who will participate in mammographic screenings organized by the "Prevention Caravan" and who, due to age or other factors, are not eligible for breast cancer screening programs through the National Health Service (NHS). These screenings are primarily offered to women experiencing social or economic hardship, such as those living in suburban areas of Italian cities, women in detention, prison staff, and women residing in shelters. However, the program is also open to all women who exceed the age limits set by regional screening programs. Awareness of the "Prevention Caravan" program raises through advertising campaigns, making it accessible to a wider audience, and participants can easily register online. A total of 35,000 women will be enrolled.
Who may be able to join
- Women who participate in the "Prevention Caravan" program;
- Women who undergo breast cancer screening, including mammography or breast ultrasound;
- Women who complete the MEDAS questionnaire.
Who cannot join
- Women who do not participate in the "Prevention Caravan" program;
- Women who participate in the "Prevention Caravan" program but undergo screenings or consultations for conditions other than breast cancer, such as gynecological cancers, thyroid ultrasounds, or dermatological evaluations;
- Women who do not complete the MEDAS questionnaire.
About this study
Official title: Adherence to the Mediterranean Diet Among Women Attending Mammographic Screening in the "Prevention Caravan" by Komen Italy: a Cross-sectional Study
The PREVCAR study is a cross-sectional investigation aimed at evaluating dietary habits among women undergoing breast cancer screening. Specifically, the study focuses on adherence to the Mediterranean diet, a dietary pattern recognized for its potential protective role against chronic diseases, including breast cancer. The PREVCAR study will include approximately 35,000 women aged 18 and older who participate in the "Prevention Caravan" and complete both the breast cancer screening and the MEDAS (Mediterranean Diet Adherence Screener) questionnaire. This 14-item questionnaire measures dietary behavior, with scores reflecting levels of adherence to the Mediterranean diet.
The primary objective of the study is to determine the average MEDAS score among participants. Secondary objectives include analyzing how adherence varies across different known breast cancer risk factors-such as age, menopausal status, hormonal therapy use, and reproductive history-and assessing the prevalence of malignant breast lesions identified through the screening.
- Conditions
- Breast Cancer Prevention
- Being tested
- Lifestyle and Nutrition Promotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle and Nutrition PromotionBehavioural
Adherence to the Mediterranean diet
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the MedDiet
To assess adherence to the MedDiet, as measured by the Mediterranean Diet Adherence Screener (MEDAS) questionnaire, among women participating in mammographic screenings organized by the "Prevention Caravan" program. Adherence to the MedDiet was evaluated using the 14-item MEDAS questionnaire (S), a validated tool designed to assess specific dietary behaviors-including the consumption of olive oil, fruits, vegetables, legumes, fish, white meat, and wine-as well as the intake of foods considered inconsistent with the Mediterranean dietary pattern, such as red meat, butter, and sugar-sweetened beverages. Each item is scored as 0 or 1 based on the participant's response, resulting in a total score ranging from 0 to 14. Higher scores indicate greater adherence: scores above 10 are classified as excellent, scores between 8 and 10 as good, and scores below 8 as poor adherence to the MedDiet.
Measured: At the moment of enrollment
Secondary outcomes (2)
MedDiet adherence levels across different categories of known breast cancer risk factors
To assess the frequency of MedDiet adherence levels across different categories of known breast cancer risk factors
Measured: At the moment of enrollment
Malignant breast lesion
The presence of malignant breast lesion in a subgroup of women participating in mammographic screenings
Measured: After 1 year, when women will be contact by phone to collect follow-up information on the outcomes of their breast screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer PreventionStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 35,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boccia Stefania, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016711
- Sponsor's protocol ID
- 7535
- Acronym
- PREVCAR
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to the Mediterranean Diet Among Women Attending Mammographic Screening in the "Prevention Caravan" by Komen Italy: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07016711
- Acronym / sponsor ID
- PREVCAR / 7535
- Conditions
- Breast Cancer Prevention
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 35,000 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 12 Jun 2025 (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.
The PREVCAR study is a cross-sectional investigation aimed at evaluating dietary habits among women undergoing breast cancer screening. Specifically, the study focuses on adherence to the Mediterranean diet, a dietary pattern recognized for its potential protective role against chronic diseases, including breast cancer. The PREVCAR study will include approximately 35,000 women aged 18 and older who participate in the "Prevention Caravan" and complete both the breast cancer screening and the MEDAS (Mediterranean Diet Adherence Screener) questionnaire. This 14-item questionnaire measures dietary behavior, with scores reflecting levels of adherence to the Mediterranean diet.
The primary objective of the study is to determine the average MEDAS score among participants. Secondary objectives include analyzing how adherence varies across different known breast cancer risk factors-such as age, menopausal status, hormonal therapy use, and reproductive history-and assessing the prevalence of malignant breast lesions identified through the screening.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- The study will focus on women aged 18 and older who will participate in mammographic screenings organized by the "Prevention Caravan" and who, due to age or other factors, are not eligible for breast cancer screening programs through the National Health Service (NHS). These screenings are primarily offered to women experiencing social or economic hardship, such as those living in suburban areas of Italian cities, women in detention, prison staff, and women residing in shelters. However, the program is also open to all women who exceed the age limits set by regional screening programs. Awareness of the "Prevention Caravan" program raises through advertising campaigns, making it accessible to a wider audience, and participants can easily register online. A total of 35,000 women will be enrolled.
Key inclusion criteria (3 listed)
- Women who participate in the "Prevention Caravan" program;
- Women who undergo breast cancer screening, including mammography or breast ultrasound;
- Women who complete the MEDAS questionnaire.
Key exclusion criteria (3 listed)
- Women who do not participate in the "Prevention Caravan" program;
- Women who participate in the "Prevention Caravan" program but undergo screenings or consultations for conditions other than breast cancer, such as gynecological cancers, thyroid ultrasounds, or dermatological evaluations;
- Women who do not complete the MEDAS questionnaire.
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 |
|---|---|---|
| Lifestyle and Nutrition PromotionAdherence to the Mediterranean diet | Behavioural | – |
Primary outcome
Adherence to the MedDiet
Time frame: At the moment of enrollment
To assess adherence to the MedDiet, as measured by the Mediterranean Diet Adherence Screener (MEDAS) questionnaire, among women participating in mammographic screenings organized by the "Prevention Caravan" program. Adherence to the MedDiet was evaluated using the 14-item MEDAS questionnaire (S), a validated tool designed to assess specific dietary behaviors-including the consumption of olive oil, fruits, vegetables, legumes, fish, white meat, and wine-as well as the intake of foods considered inconsistent with the Mediterranean dietary pattern, such as red meat, butter, and sugar-sweetened beverages. Each item is scored as 0 or 1 based on the participant's response, resulting in a total score ranging from 0 to 14. Higher scores indicate greater adherence: scores above 10 are classified as excellent, scores between 8 and 10 as good, and scores below 8 as poor adherence to the MedDiet.
2 secondary outcomes
MedDiet adherence levels across different categories of known breast cancer risk factors
Time frame: At the moment of enrollment
Malignant breast lesion
Time frame: After 1 year, when women will be contact by phone to collect follow-up information on the outcomes of their breast screening
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 12 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Prevention, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 3 inclusion and 3 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 12 Jun 2025. 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?
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?
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?
Adherence to the MedDiet (time frame: At the moment of enrollment). 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 12 Jun 2025.