The Role of Lifestyle Factors in Breast Cancer-Related Outcomes

NCT02079662 | Active Not Recruiting FDA Drug

• 2 other identifiers: 2012-0112NCI-2014-02449
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

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.

Other: Behavioral, Psychological or Informational Intervention; Other: Cognitive Intervention; Other: Computer-Assisted Intervention; Other: Counseling; Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (standard of care)

ACTIVE COMPARATOR

Patients undergo standard of care.

Other: Best Practice; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Behavioral, Psychological or Informational Intervention OTHER

Undergo IO intervention

Arm I (IO interventions)

Best Practice OTHER

Undergo standard of care

Also known as: standard of care, standard therapy

Arm II (standard of care)

Cognitive Intervention OTHER

Undergo IO intervention

Arm I (IO interventions)

Computer-Assisted Intervention OTHER

Undergo IO intervention

Arm I (IO interventions)

Counseling OTHER

Undergo counseling

Also known as: Counseling Intervention

Arm I (IO interventions)

Exercise Intervention BEHAVIORAL

Undergo IO intervention

Arm I (IO interventions)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (IO interventions); Arm II (standard of care)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (IO interventions); Arm II (standard of care)

Questionnaire Administration OTHER

Ancillary studies

Arm I (IO interventions); Arm II (standard of care)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Counseling

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Lorenzo Cohen

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 6, 2014
• Study Start: June 13, 2013
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)