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.
PRIMARY OBJECTIVES: I. Assess the feasibility of a randomized controlled trial involving a mobile, standardized, comprehensive integrative oncology (IO) prevention program. SECONDARY OBJECTIVES: I. 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
Attend IO prevention program
Ancillary studies
M D Anderson Cancer Center
Houston, Texas, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 year
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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 year
Gut microbiome
Sequence processing and analysis will be performed using specific software for comparison and analysis of microbial communities.
Time frame: Up to 1 year