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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-02449 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2012-0112 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (IO interventions) | Experimental | 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. |
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| Arm II (standard of care) | Active Comparator | Patients undergo standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral, Psychological or Informational Intervention | Other | Undergo IO intervention |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Cohen | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| Best Practice | Other | Undergo standard of care |
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| Cognitive Intervention | Other | Undergo IO intervention |
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| Computer-Assisted Intervention | Other | Undergo IO intervention |
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| Counseling | Other | Undergo counseling |
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| Exercise Intervention | Behavioral | Undergo IO intervention |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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