Trials / Active Not Recruiting

Active Not RecruitingNCT02079662

The Role of Lifestyle Factors in Breast Cancer-Related Outcomes

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

Status: Active Not Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 110 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
OTHER	Behavioral, Psychological or Informational Intervention	Undergo IO intervention
OTHER	Best Practice	Undergo standard of care
OTHER	Cognitive Intervention	Undergo IO intervention
OTHER	Computer-Assisted Intervention	Undergo IO intervention
OTHER	Counseling	Undergo counseling
BEHAVIORAL	Exercise Intervention	Undergo IO intervention
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

Start date: 2013-06-13
Primary completion: 2030-12-31
Completion: 2030-12-31
First posted: 2014-03-06
Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT02079662. Inclusion in this directory is not an endorsement.