PremenopausalNCT03448003
Comprehensive Lifestyle Change To Prevent Breast Cancer
A study testing Cancer Prevention and Questionnaire Administration in people with Premenopausal, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies how well comprehensive lifestyle change works in preventing patients from breast cancer. A program including dietary recommendations, physical activity, stress management and mindfulness training, learning sleep hygiene techniques, and behavioral counseling in addition to social support may help… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenopausal
- What is being tested?
- Cancer Prevention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2019to 31 Aug 2027
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to read, write, and speak English
- Premenopausal
- A body mass index (BMI) >= 25
- Have intact breasts and ovaries
- Able to provide informed consent to participate in the study
- Meet all the following criteria related to lifestyle: a) consume less than 3 servings of vegetables (excluding any fried servings) and 1 serving of fruit (not including juice)/day; b) engage in less than 150 minutes moderate/vigorous intensity activity per week, defined as anything that causes small increases in breathing or heart rate for a sustained amount of time (e.g., brisk walking, bicycling); c) engage in a mind-body practice less once per week
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- Able mentally and physically to participate in interventions in this study (Note: If there are one or more positive responses to the Physical Activity Readiness Questionnaire [PARQ], then a physician-release for exercise is required prior to obtaining consent)
- Access to internet connection
- Able to come to University of Texas (UT) MD Anderson for the orientation and assessment sessions
Who cannot join
- Any personal history of cancer, including ductal carcinoma in situ (DCIS) and not including non-melanoma skin cancers
- Any major thought disorder (e.g., schizophrenia, dementia)
- Communication barriers (e.g. hard of hearing)
- Poorly or uncontrolled diabetes in the opinion of the physician(s)
- Being pregnant or planning on becoming pregnant within the next year
- Contemplating any new pharmacologic/hormonal or prophylactic surgical intervention for breast cancer prevention within the next year (Note: Individuals taking tamoxifen, arimidex or other hormonal prevention strategies at time of consent will be eligible)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Lifestyle Change to Prevent Breast Cancer: A Feasibility Trial
This trial studies how well comprehensive lifestyle change works in preventing patients from breast cancer. A program including dietary recommendations, physical activity, stress management and mindfulness training, learning sleep hygiene techniques, and behavioral counseling in addition to social support may help patients who may be at risk for breast cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess the feasibility of a randomized controlled trial involving a mobile, standardized, comprehensive integrative oncology (IO) prevention program.
SECONDARY OBJECTIVES:
- Compare group differences over time in biological pathways including: immune function, gut microbiome, endocrine function, insulin and glucose metabolism, inflammation, other cancer-related pathways (from peripheral blood), antioxidant capacity, and nutrient levels.
II. Determine whether the IO group has improved patient reported outcomes over time including: quality of life, sleep disturbances, aspects of mental health, and psychosocial measures including: mindfulness, social support, and measures of positive growth.
III. Compare group differences over time in dietary patterns, fitness levels, percent body fat, and anthropometrics.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients attend IO prevention program consisting of 1-2 physical activity, nutrition and diet, and mind-body practice sessions over 60 minutes weekly for 12 weeks. Patients also attend a behavioral counseling session once weekly for up to 26 weeks. Patients complete exercises over 30-60 minutes 3-5 times weekly for 12 weeks.
GROUP II: Patients receive no intervention. After 26 weeks, patients may crossover to Group I.
After completion of study, patients are followed up at 26 weeks and 1 year.
- Conditions
- Premenopausal
- Being tested
- Cancer Prevention, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer PreventionOther
Attend IO prevention program
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (IO prevention program) | Experimental | Patients attend IO prevention program consisting of 1-2 physical activity, nutrition and diet, and mind-body practice sessions over 60 minutes weekly for 12 weeks. Patients also attend a behavioral counseling session once weekly for up to 26 weeks. Patients complete exercises over 30-60 minutes 3-5 times weekly for 12 weeks. Receives: Other: Cancer Prevention; Other: Questionnaire Administration |
| Group II (no intervention) | Active comparator | Patients receive no intervention. After 26 weeks, patients may crossover to Group I. Receives: Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent rate
Will calculate the rates, frequencies, and 90% confidence intervals (CIs) of means by group, as well as for the differences between intervention groups as applicable. Will also examine demographic factors such as age, marital status, number of children, and employment status as they related to feasibility in terms of consent, adherence to the intervention, and retention in the study.
Measured: Up to 1 year
Treatment group compliance rate
Will be defined as attending at least 50% of sessions during the intervention delivery weeks (first 26 weeks) in the integrative oncology (IO) group. Will calculate the rates, frequencies, and 90% CIs of means by group, as well as for the differences between intervention groups as applicable. Will also examine demographic factors such as age, marital status, number of children, and employment status as they related to feasibility in terms of consent, adherence to the intervention, and retention in the study.
Measured: Up to 1 year
Retention rate
Will calculate the rates, frequencies, and 90% CIs of means by group, as well as for the differences between intervention groups as applicable. Will also examine demographic factors such as age, marital status, number of children, and employment status as they related to feasibility in terms of consent, adherence to the intervention, and retention in the study.
Measured: Up to 1 year
Secondary outcomes (6)
Group differences over time in biological pathways
Will first conduct extensive descriptive analyses on the data collected at baseline and at each follow-up. Descriptive statistics including 90% CIs will be computed for the relevant measures. Will examine distribution characteristics of the variables using box plots, histograms, scatter plots, and the Kolmogorov-Smirnov test of normality where appropriate. Distribution assumptions will be evaluated, and if indicated, normalizing transformations or robust procedures will be used. Will evaluate bivariate associations between the outcome measures and selected demographic and medical variables, including age, ethnicity, body mass index, and cancer history using Pearson product-moment correlation coefficients, chi-squared tests, or other methods where appropriate. Will use generalized linear mixed model regression (GLMM). Separate sets of analyses will be conducted for each criterion variable.
Measured: Up to 1 year
Group differences over time in dietary patterns
Will first conduct extensive descriptive analyses on the data collected at baseline and at each follow-up. Descriptive statistics including 90% CIs will be computed for the relevant measures. Will examine distribution characteristics of the variables using box plots, histograms, scatter plots, and the Kolmogorov-Smirnov test of normality where appropriate. Distribution assumptions will be evaluated, and if indicated, normalizing transformations or robust procedures will be used. Will evaluate bivariate associations between the outcome measures and selected demographic and medical variables, including age, ethnicity, body mass index, and cancer history using Pearson product-moment correlation coefficients, chi-squared tests, or other methods where appropriate. Will use GLMM. Separate sets of analyses will be conducted for each criterion variable.
Measured: Up to 1 year
Group differences over time in fitness levels
Will first conduct extensive descriptive analyses on the data collected at baseline and at each follow-up. Descriptive statistics including 90% CIs will be computed for the relevant measures. Will examine distribution characteristics of the variables using box plots, histograms, scatter plots, and the Kolmogorov-Smirnov test of normality where appropriate. Distribution assumptions will be evaluated, and if indicated, normalizing transformations or robust procedures will be used. Will evaluate bivariate associations between the outcome measures and selected demographic and medical variables, including age, ethnicity, body mass index, and cancer history using Pearson product-moment correlation coefficients, chi-squared tests, or other methods where appropriate. Will use GLMM. Separate sets of analyses will be conducted for each criterion variable.
Measured: Up to 1 year
Group differences over time in percent body fat
Will first conduct extensive descriptive analyses on the data collected at baseline and at each follow-up. Descriptive statistics including 90% CIs will be computed for the relevant measures. Will examine distribution characteristics of the variables using box plots, histograms, scatter plots, and the Kolmogorov-Smirnov test of normality where appropriate. Distribution assumptions will be evaluated, and if indicated, normalizing transformations or robust procedures will be used. Will evaluate bivariate associations between the outcome measures and selected demographic and medical variables, including age, ethnicity, body mass index, and cancer history using Pearson product-moment correlation coefficients, chi-squared tests, or other methods where appropriate. Will use GLMM. Separate sets of analyses will be conducted for each criterion variable.
Measured: Up to 1 year
Group differences over time in anthropometrics
Will first conduct extensive descriptive analyses on the data collected at baseline and at each follow-up. Descriptive statistics including 90% CIs will be computed for the relevant measures. Will examine distribution characteristics of the variables using box plots, histograms, scatter plots, and the Kolmogorov-Smirnov test of normality where appropriate. Distribution assumptions will be evaluated, and if indicated, normalizing transformations or robust procedures will be used. Will evaluate bivariate associations between the outcome measures and selected demographic and medical variables, including age, ethnicity, body mass index, and cancer history using Pearson product-moment correlation coefficients, chi-squared tests, or other methods where appropriate. Will use GLMM. Separate sets of analyses will be conducted for each criterion variable.
Measured: Up to 1 year
Gut microbiome
Sequence processing and analysis will be performed using specific software for comparison and analysis of microbial communities.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start4 Apr 2019
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PremenopausalStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorenzo Cohen, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448003
- Sponsor's protocol ID
- 2017-0479
- Other IDs
- NCI-2018-00915, 2017-0479
- Status last verified
- Aug 2026
- First submitted
- 16 Feb 2018
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Lifestyle Change to Prevent Breast Cancer: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT03448003
- Acronym / sponsor ID
- 2017-0479
- Conditions
- Premenopausal
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 27 Feb 2018 (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.
This trial studies how well comprehensive lifestyle change works in preventing patients from breast cancer. A program including dietary recommendations, physical activity, stress management and mindfulness training, learning sleep hygiene techniques, and behavioral counseling in addition to social support may help patients who may be at risk for breast cancer.
Detailed description
PRIMARY OBJECTIVES:
- Assess the feasibility of a randomized controlled trial involving a mobile, standardized, comprehensive integrative oncology (IO) prevention program.
SECONDARY OBJECTIVES:
- Compare group differences over time in biological pathways including: immune function, gut microbiome, endocrine function, insulin and glucose metabolism, inflammation, other cancer-related pathways (from peripheral blood), antioxidant capacity, and nutrient levels.
II. Determine whether the IO group has improved patient reported outcomes over time including: quality of life, sleep disturbances, aspects of mental health, and psychosocial measures including: mindfulness, social support, and measures of positive growth.
III. Compare group differences over time in dietary patterns, fitness levels, percent body fat, and anthropometrics.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients attend IO prevention program consisting of 1-2 physical activity, nutrition and diet, and mind-body practice sessions over 60 minutes weekly for 12 weeks. Patients also attend a behavioral counseling session once weekly for up to 26 weeks. Patients complete exercises over 30-60 minutes 3-5 times weekly for 12 weeks.
GROUP II: Patients receive no intervention. After 26 weeks, patients may crossover to Group I.
After completion of study, patients are followed up at 26 weeks and 1 year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (IO prevention program) | Experimental | Other: Cancer Prevention, Other: Questionnaire AdministrationPatients attend IO prevention program consisting of 1-2 physical activity, nutrition and diet, and mind-body practice sessions over 60 minutes weekly for 12 weeks. Patients also attend a behavioral counseling session once weekly for up to 26 weeks. Patients complete exercises over 30-60 minutes 3-5 times weekly for 12 weeks. |
| Group II (no intervention) | Active comparator | Other: Questionnaire AdministrationPatients receive no intervention. After 26 weeks, patients may crossover to Group I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able to read, write, and speak English
- Premenopausal
- A body mass index (BMI) >= 25
- Have intact breasts and ovaries
- Able to provide informed consent to participate in the study
Key exclusion criteria (6 listed)
- Any personal history of cancer, including ductal carcinoma in situ (DCIS) and not including non-melanoma skin cancers
- Any major thought disorder (e.g., schizophrenia, dementia)
- Communication barriers (e.g. hard of hearing)
- Poorly or uncontrolled diabetes in the opinion of the physician(s)
- Being pregnant or planning on becoming pregnant within the next year
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 |
|---|---|---|
| Cancer PreventionAttend IO prevention program | Other | Group I (IO prevention program) |
| Questionnaire AdministrationAncillary studies | Other | Group I (IO prevention program), Group II (no intervention) |
Primary outcome
Consent rate
Time frame: Up to 1 year
Will calculate the rates, frequencies, and 90% confidence intervals (CIs) of means by group, as well as for the differences between intervention groups as applicable. Will also examine demographic factors such as age, marital status, number of children, and employment status as they related to feasibility in terms of consent, adherence to the intervention, and retention in the study.
Treatment group compliance rate
Time frame: Up to 1 year
Will be defined as attending at least 50% of sessions during the intervention delivery weeks (first 26 weeks) in the integrative oncology (IO) group. Will calculate the rates, frequencies, and 90% CIs of means by group, as well as for the differences between intervention groups as applicable. Will also examine demographic factors such as age, marital status, number of children, and employment status as they related to feasibility in terms of consent, adherence to the intervention, and retention in the study.
Retention rate
Time frame: Up to 1 year
Will calculate the rates, frequencies, and 90% CIs of means by group, as well as for the differences between intervention groups as applicable. Will also examine demographic factors such as age, marital status, number of children, and employment status as they related to feasibility in terms of consent, adherence to the intervention, and retention in the study.
6 secondary outcomes
Group differences over time in biological pathways
Time frame: Up to 1 year
Group differences over time in dietary patterns
Time frame: Up to 1 year
Group differences over time in fitness levels
Time frame: Up to 1 year
Group differences over time in percent body fat
Time frame: Up to 1 year
Group differences over time in anthropometrics
Time frame: Up to 1 year
Gut microbiome
Time frame: Up to 1 year
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 11 Aug 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Lorenzo Cohen principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer Prevention and Questionnaire Administration in people with Premenopausal, run by M.D. Anderson Cancer Center at 1 site in United States.
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 9 inclusion and 6 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 11 Aug 2026. 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 United States. 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?
Consent rate (time frame: Up to 1 year). The study lists 3 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 11 Aug 2026.