Breast CancerLifestyleNCT06866093
The Study is Observational and Retrospective: Lifestyle, BMI and Activity Physical.
An observational study of Breast Cancer and Body Weight Change, run by National Cancer Institute, Naples at 1 site in Italy.
Trial summary
The goal of this observational-retrospective study is to learn about the long-term effects of a lifestyle intervention inclusive of dietary counselling and physical activity advice, on body weight in female breast cancer survivors who took the intervention in previous years compared to those who did not take it. Read more about this study
- Who is it for?
- Ages 30 to 74 years, women only
- Conditions the study is for
- Breast Cancer, Body Weight Change
- What is being tested?
- Lifestyle
- How many people
- 112 participants
- Where
- 1 siteItaly
- Study dates
- 4 Sep 2023to 31 Dec 2026
- 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 30 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with a 5-year diagnosis of breast cancer, living in Italy and followed up in the participating hospitals.
Who may be able to join
- Surgery for primary breast cancer performed at least 5 years prior to the interview.
- Women who have joined the DEDiCa trial or who have refused to participate for reasons not related to serious health conditions or disease progression.
- Those who are able to sign the informed consent.
Who cannot join
- Age <30 years.
- Primary diagnosis of metastatic breast cancer.
- Diagnosis of other malignancies prior to the diagnosis of breast cancer.
- Those who are unable to sign the informed consent or who deny to be contacted by telephone.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Cancer Institute Foundation G. Pascale of Naples
Naples, 80131
About this study
Official title: Evaluation of the Long-term Effect of Integrated Lifestyle Treatments on Dietary Habits, Sedentary Behavior, Anthropometry, Quality of Life in Female Breast Cancer Survivors, Through Traditional and Innovative Statistical Methods.
The goal of this observational-retrospective study is to learn about the long-term effects of a lifestyle intervention inclusive of dietary counselling and physical activity advice, on body weight in female breast cancer survivors who took the intervention in previous years compared to those who did not take it.
The main question it aims to answer is:
Does a long-term lifestyle intervention help to control body weight 5 years after breast cancer diagnosis? Participants are asked to answer online survey questions about their anthropomethry, clinical conditions, socio-economical status, dietary habits, physical activity levels, quality of life, sleep quality and pshycological distress.
Read the detailed description
Investigators will use data from 428 women with a 5-yr primary diagnosis of BC (stages I-III at ages ≥30 <75 anni). Half of this sample (N=214) who followed integrated lifestyle treatment of behavioral modification of diet and physical activity conducted by Pascale Institute since 2016; the other half (N=214) will be patients who were eligible to participate but did not for logistic reasons.
The present study aims to enroll 428 women with prior primary diagnosis of breast cancer. Half of the patients (N = 214) had previously followed the lifestyle treatment of DEDiCa trial on the modification of eating and physical activity habits (Eudract n. 2015-005147-14) conducted by the Oncologic Institute Pascale in Naples (Italy) since Nov 2016; the other half of the patients were 214 who had refused to participate in the aforementioned trial for reasons unrelated to serious health conditions or progression of the disease.
- Conditions
- Breast Cancer, Body Weight Change
- Being tested
- Lifestyle
- Keywords
- Lifestyle study
- Medical subject headings
- Breast Neoplasms, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifestyleOther
Participants are asked to answer online survey questions about their anthropomethry, clinical conditions, socio-economical status, dietary habits, physical activity levels, quality of life, sleep quality and pshycological distress.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle | The cohort incluedes women (N=428) with a 5-year primary diagnosis of breast cancer eligible to participate in a diet and exercise trial (DEDiCa) in the previous years. Half of them actively participated in the trial and half did not for reasons other than health related issues. Those who consent to participate to the current observational study completed a series of questionnaires. Receives: Other: Lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of body weight in kilograms
The primary objective of the study is to evaluate whether an integrated lifestyle cancer treatment (L-INT) with nutritional and physical activity counseling, within the first year of diagnosis of histologically confirmed primary breast cancer, can result in better control of body weight (measured as BMI classes) after 5 years from diagnosis compared to those who had not adhered to integrated lifestyle treatments (no-INT).
Measured: Baseline
Measurement of body height in meters
The primary objective of the study is to evaluate whether an integrated lifestyle cancer treatment (L-INT) with nutritional and physical activity counseling, within the first year of diagnosis of histologically confirmed primary breast cancer, can result in better control of body weight (measured as BMI classes) after 5 years from diagnosis compared to those who had not adhered to integrated lifestyle treatments (no-INT).
Measured: Baseline
Secondary outcomes (4)
Units on a Scale adherence to the Mediterranean diet.
The secondary objectives aim to evaluate the current adherence to the Mediterranean diet and the following variables: disease-free survival, new onset of chronic diseases (second cancer, diabetes, cardiovascular events, osteoporosis/bone fractures), quality of life including psychological distress and sleep quality. As an exploratory secondary objective, on a subgroup (N = 40), plans to study the microbiome of breast cancer tissue stored in the biobank of the Pascale Institute, to relate it to the characteristics of the disease and the patients' lifestyle.
Measured: Baseline
Units on a Scale moderate physical activity.
The secondary objectives of study is moderate physical activity, together at the association between current adherence to the Mediterranean diet and the following variables: current body weight (BMI), disease-free survival, new onset of chronic diseases (second cancer, diabetes, cardiovascular events, osteoporosis/bone fractures), quality of life including psychological distress, quality of sleep and economic sustainability of the disease.
Measured: Baseline
Units on a Scale the microbiome of breast tissue
As a secondary exploratory and innovative objective, on a subgroup (N=40), we plan to study the microbiome of the breast tissue stored in the biobank of the Pascale Institute, to relate it to the characteristics of the disease and the patient.
Measured: Baseline
Units on a Scale of questionnaries quality of life
The study aim on quality of life including psychological distress, quality of sleep and economic sustainability of the disease.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start4 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livia S Augustin, National Cancer Institute, Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866093
- Sponsor's protocol ID
- 44/22
- Acronym
- Lifestyle
- Status last verified
- Jan 2025
- First submitted
- 19 Feb 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Long-term Effect of Integrated Lifestyle Treatments on Dietary Habits, Sedentary Behavior, Anthropometry, Quality of Life in Female Breast Cancer Survivors, Through Traditional and Innovative Statistical Methods.
- ClinicalTrials.gov ID
- NCT06866093
- Acronym / sponsor ID
- Lifestyle / 44/22
- Conditions
- Breast Cancer, Body Weight Change
- Keywords
- Lifestyle study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 112 participants (actual)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Mar 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 goal of this observational-retrospective study is to learn about the long-term effects of a lifestyle intervention inclusive of dietary counselling and physical activity advice, on body weight in female breast cancer survivors who took the intervention in previous years compared to those who did not take it.
The main question it aims to answer is:
Does a long-term lifestyle intervention help to control body weight 5 years after breast cancer diagnosis? Participants are asked to answer online survey questions about their anthropomethry, clinical conditions, socio-economical status, dietary habits, physical activity levels, quality of life, sleep quality and pshycological distress.
Detailed description
Investigators will use data from 428 women with a 5-yr primary diagnosis of BC (stages I-III at ages ≥30 <75 anni). Half of this sample (N=214) who followed integrated lifestyle treatment of behavioral modification of diet and physical activity conducted by Pascale Institute since 2016; the other half (N=214) will be patients who were eligible to participate but did not for logistic reasons.
The present study aims to enroll 428 women with prior primary diagnosis of breast cancer. Half of the patients (N = 214) had previously followed the lifestyle treatment of DEDiCa trial on the modification of eating and physical activity habits (Eudract n. 2015-005147-14) conducted by the Oncologic Institute Pascale in Naples (Italy) since Nov 2016; the other half of the patients were 214 who had refused to participate in the aforementioned trial for reasons unrelated to serious health conditions or progression of the disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle | – | Other: LifestyleThe cohort incluedes women (N=428) with a 5-year primary diagnosis of breast cancer eligible to participate in a diet and exercise trial (DEDiCa) in the previous years. Half of them actively participated in the trial and half did not for reasons other than health related issues. Those who consent to participate to the current observational study completed a series of questionnaires. |
Who may qualify
- Ages
- 30 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with a 5-year diagnosis of breast cancer, living in Italy and followed up in the participating hospitals.
Key inclusion criteria (3 listed)
- Surgery for primary breast cancer performed at least 5 years prior to the interview.
- Women who have joined the DEDiCa trial or who have refused to participate for reasons not related to serious health conditions or disease progression.
- Those who are able to sign the informed consent.
Key exclusion criteria (4 listed)
- Age <30 years.
- Primary diagnosis of metastatic breast cancer.
- Diagnosis of other malignancies prior to the diagnosis of breast cancer.
- Those who are unable to sign the informed consent or who deny to be contacted by telephone.
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 |
|---|---|---|
| LifestyleParticipants are asked to answer online survey questions about their anthropomethry, clinical conditions, socio-economical status, dietary habits, physical activity levels, quality of life, sleep quality and pshycological distress. | Other | Lifestyle |
Primary outcome
Measurement of body weight in kilograms
Time frame: Baseline
The primary objective of the study is to evaluate whether an integrated lifestyle cancer treatment (L-INT) with nutritional and physical activity counseling, within the first year of diagnosis of histologically confirmed primary breast cancer, can result in better control of body weight (measured as BMI classes) after 5 years from diagnosis compared to those who had not adhered to integrated lifestyle treatments (no-INT).
Measurement of body height in meters
Time frame: Baseline
The primary objective of the study is to evaluate whether an integrated lifestyle cancer treatment (L-INT) with nutritional and physical activity counseling, within the first year of diagnosis of histologically confirmed primary breast cancer, can result in better control of body weight (measured as BMI classes) after 5 years from diagnosis compared to those who had not adhered to integrated lifestyle treatments (no-INT).
4 secondary outcomes
Units on a Scale adherence to the Mediterranean diet.
Time frame: Baseline
Units on a Scale moderate physical activity.
Time frame: Baseline
Units on a Scale the microbiome of breast tissue
Time frame: Baseline
Units on a Scale of questionnaries quality of life
Time frame: Baseline
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 10 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Body Weight Change, run by National Cancer Institute, Naples at 1 site in Italy.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2025. 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 Italy. 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?
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?
Measurement of body weight in kilograms (time frame: Baseline). The study lists 2 primary outcomes in all. 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 10 Mar 2025.