The Role of Lifestyle Factors in Breast Cancer-Related Outcomes
NCT ID: NCT02079662
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
110 participants
INTERVENTIONAL
2013-06-13
2030-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (IO interventions)
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.
Behavioral, Psychological or Informational Intervention
Undergo IO intervention
Cognitive Intervention
Undergo IO intervention
Computer-Assisted Intervention
Undergo IO intervention
Counseling
Undergo counseling
Exercise Intervention
Undergo IO intervention
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (standard of care)
Patients undergo standard of care.
Best Practice
Undergo standard of care
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Behavioral, Psychological or Informational Intervention
Undergo IO intervention
Best Practice
Undergo standard of care
Cognitive Intervention
Undergo IO intervention
Computer-Assisted Intervention
Undergo IO intervention
Counseling
Undergo counseling
Exercise Intervention
Undergo IO intervention
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Lorenzo Cohen
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2014-02449
Identifier Type: REGISTRY
Identifier Source: secondary_id
2012-0112
Identifier Type: OTHER
Identifier Source: secondary_id
2012-0112
Identifier Type: -
Identifier Source: org_study_id