The Role of Lifestyle Factors in Breast Cancer-Related Outcomes

• ClinicalTrials.gov Identifier: NCT02079662
• Recruitment Status: Active, not recruiting
• First Posted: March 6, 2014
• Last Update Posted: May 11, 2023
• Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Tracking Information

• First Submitted Date: March 4, 2014
• First Posted Date: March 6, 2014
• Last Update Posted Date: May 11, 2023
• Actual Study Start Date: June 13, 2013
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 1, 2019)

• Disease-free survival (DFS) [ Time Frame: Up to 5 years ]
  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.
• Changes in biological pathways [ Time Frame: Baseline to 5 years ]
  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.
• Changes in dietary patterns [ Time Frame: Baseline to 5 years ]
  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.
• Changes in fitness levels [ Time Frame: Baseline to 5 years ]
  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.
• Changes in heart rate variability [ Time Frame: Baseline to 5 years ]
  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.
• Changes in quality of life (including fatigue and sleep disturbances) [ Time Frame: Baseline to 5 years ]
  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.

Original Primary Outcome Measures (submitted: March 5, 2014)

Disease-Free Survival (DFS) [ Time Frame: 3 months ]

Primary endpoint of study, disease-free survival (DFS), analyzed using a multivariate comparison of DSF for each group using a Cox proportional hazards analysis. The following considered as potential covariates in analysis (tumor and nodal status, menopausal status at diagnosis, tumor factors, treatment regimen, etc). For the Integrative Oncology (IO) group, we will determine compliance with practice. Changes in diet, physical activity, and stress management practices assessed in both groups. Exploratory analysis will examine change in lifestyle as a mediator of clinical, biological, and patient reported outcomes.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Role of Lifestyle Factors in Breast Cancer-Related Outcomes
• Official Title: Integrative Oncology Program in Improving Cancer-Related Outcomes in Patients With Stage II or III Breast Cancer Undergoing Radiation Therapy
• 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.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• 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

• Other: Behavioral, Psychological or Informational Intervention
  Undergo IO intervention
• Other: Best Practice
  Undergo standard of care
  Other Names:

  • standard of care
  • standard therapy
• Other: Cognitive Intervention
  Undergo IO intervention
• Other: Computer-Assisted Intervention
  Undergo IO intervention
• Other: Counseling
  Undergo counseling
  Other Name: Counseling Intervention
• Behavioral: Exercise Intervention
  Undergo IO intervention
• Other: Laboratory Biomarker Analysis
  Correlative studies
• Other: Quality-of-Life Assessment
  Ancillary studies
  Other Name: Quality of Life Assessment
• Other: Questionnaire Administration
  Ancillary studies

Study Arms

• Experimental: 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.
  Interventions:

  • 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
• Active Comparator: Arm II (standard of care)
  Patients undergo standard of care.
  Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: October 6, 2022): 110
• Original Estimated Enrollment (submitted: March 5, 2014): 160
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02079662
• Other Study ID Numbers: 2012-0112; NCI-2014-02449 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 2012-0112 ( Other Identifier: M D Anderson Cancer Center )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: M.D. Anderson Cancer Center
• Original Responsible Party: Same as current
• Current Study Sponsor: M.D. Anderson Cancer Center
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Lorenzo Cohen; M.D. Anderson Cancer Center

• PRS Account: M.D. Anderson Cancer Center
• Verification Date: May 2023