The Role of Lifestyle Factors in Breast Cancer-Related Outcomes

Study Overview
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Brief Summary
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This randomized clinical trial studies an integrative oncology (making changes in lifestyle and behavior) program in improving cancer-related outcomes in patients with stage II or III breast cancer undergoing radiation therapy. An integrative oncology program consisting of dietary recommendations, physical activity, stress management, social support, and control of environmental contaminants may modify cancer-related biological processes, influence long-term treatment results, and improve the quality of life of patients.

Detailed Description
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PRIMARY OBJECTIVES: I. Determine whether the Integrative Oncology group (IO) has increased disease-free survival (time to recurrence) than the standard of care control group (SC). II. Compare group differences over time in biological pathways including: immune function, endocrine function, insulin and glucose metabolism, cancer-related pathways (from peripheral blood), antioxidant capacity, and nutrient levels. III. Examine group differences in overall survival. IV. Compare group differences over time in dietary patterns and fitness levels. V. Determine whether the IO group has improved patient reported outcomes including fatigue, sleep disturbances, radiotherapy toxicity (dermatitis, skin ulceration, pruritis, etc.), gut microbiome, other aspects of Quality of Life (QOL), mental health, social support, and measures of positive growth. VI. Compare group differences over time in heart rate variability. VII. Determine cost-effectiveness analysis and work and/or home productivity. SECONDARY OBJECTIVES: I. Compare group differences over time in healthy breast tissue biomarkers acquired from fine needle aspirations. II. Compare group differences in spouse or caregiver work productivity. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo up to 7 different IO intervention sessions per week during their 6-week course of radiotherapy for between 1 and 3 hours each session, in addition to, up to 6 aerobic training sessions per week and one grocery store trip during the course of the program. IO intervention programs consist of nutritional coaching, behavioral therapy, yoga and meditation practice, resistance training, and a weekly meal sharing and cooking class. Patients then have weekly meetings with the study psychologist on the computer for 6 months, followed by a monthly meeting on the computer from 6-12 months, and 2 hour meetings at all follow-up appointments during the first year after radiotherapy. ARM II: Patients undergo standard of care. After completion of study treatment, patients are followed up at 6 and 12 months and then annually for up to 4 years.

Official Title
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Integrative Oncology Program in Improving Cancer-Related Outcomes in Patients With Stage II or III Breast Cancer Undergoing Radiation Therapy

Conditions
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Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7

Intervention / Treatment
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* Other: Behavioral, Psychological or Informational Intervention
* Other: Best Practice
* Other: Cognitive Intervention
* Other: Computer-Assisted Intervention
* Other: Counseling
* Behavioral: Exercise Intervention
* Other: Laboratory Biomarker Analysis
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with stage II or III breast cancer that will be scheduled to undergo a 4 to 6-week course of radiotherapy Participants must be able to read, write, and speak English Participants must be oriented to person, place, and time Participants must also meet at least two of the following criteria related to lifestyle: 1) consume less than 3 servings of fruit and vegetable/day; 2) engage in less than 75 minutes moderate/vigorous 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); and 3) engage in a mind-body practice less than 4 times a month Participants must have a body mass index (BMI) of 24.45 or higher as assessed in the medical record Exclusion Criteria: Patients with a recurrent breast cancer diagnosis Patients with another primary cancer diagnosis within 5 years of consent, not including non-melanoma skin cancers Patients who have any major psychiatric diagnoses or thought disorder (e.g. schizophrenia, bi-polar disorder, dementia) Patients with communication barriers (e.g., hard of hearing) Patients with extreme mobility issues (e.g. unable to get in and out of a chair unassisted) Patients with poorly or uncontrolled diabetes in the opinion of the physician(s)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (IO interventions)<br>Patients undergo up to 7 different IO intervention sessions per week during their 6-week course of radiotherapy for between 1 and 3 hours each session, in addition to, up to 6 aerobic training sessions per week and one grocery store trip during the course of the program. IO intervention programs consist of nutritional coaching, behavioral therapy, yoga and meditation practice, resistance training, and a weekly meal sharing and cooking class. Patients then have weekly meetings with the study psychologist on the computer for 6 months, followed by a monthly meeting on the computer from 6-12 months, and 2 hour meetings at all follow-up appointments during the first year after radiotherapy. | Other: Behavioral, Psychological or Informational Intervention<br>* Undergo IO intervention<br>Other: Cognitive Intervention<br>* Undergo IO intervention<br>Other: Computer-Assisted Intervention<br>* Undergo IO intervention<br>Other: Counseling<br>* Undergo counseling<br>* Other names: Counseling Intervention;Behavioral: Exercise Intervention<br>* Undergo IO intervention<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (standard of care)<br>Patients undergo standard of care. | Other: Best Practice<br>* Undergo standard of care<br>* Other names: standard therapy;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival (DFS) | Will analyze DFS, using a multivariate comparison of DFS for each group using a Cox proportional hazards analysis. Will consider the following as potential covariates in the analysis (tumor and nodal status, menopausal status at diagnosis, tumor factors, treatment regimen, etc). Will obtain estimates for hazards ratios and 95% confidence intervals for the effect of the study arm and each covariate. | Up to 5 years | 
| Changes in biological pathways | Will use generalized linear mixed model regression (GLMM). Separate sets of analyses will be conducted for each criterion variable. To select the best method for modeling the repeated measures, will use the methods of Wolfinger and statistics such as Akaike's and Schwarz's information criteria. Will also use either t tests or Wilcoxon two-sample tests to analyze these data, depending on their distributions. | Baseline to 5 years | 
| Changes in dietary patterns | Will use GLMM. Separate sets of analyses will be conducted for each criterion variable. To select the best method for modeling the repeated measures, will use the methods of Wolfinger and statistics such as Akaike's and Schwarz's information criteria. Will also use either t tests or Wilcoxon two-sample tests to analyze these data, depending on their distributions. | Baseline to 5 years | 
| Changes in fitness levels | Will use GLMM. Separate sets of analyses will be conducted for each criterion variable. To select the best method for modeling the repeated measures, will use the methods of Wolfinger and statistics such as Akaike's and Schwarz's information criteria. Will also use either t tests or Wilcoxon two-sample tests to analyze these data, depending on their distributions. | Baseline to 5 years | 
| Changes in heart rate variability | Will use GLMM. Separate sets of analyses will be conducted for each criterion variable. To select the best method for modeling the repeated measures, will use the methods of Wolfinger and statistics such as Akaike's and Schwarz's information criteria. Will also use either t tests or Wilcoxon two-sample tests to analyze these data, depending on their distributions. | Baseline to 5 years | 
| Changes in quality of life (including fatigue and sleep disturbances) | Will use GLMM. Separate sets of analyses will be conducted for each criterion variable. To select the best method for modeling the repeated measures, will use the methods of Wolfinger and statistics such as Akaike's and Schwarz's information criteria. Will also use either t tests or Wilcoxon two-sample tests to analyze these data, depending on their distributions. | Baseline to 5 years |