The Role of Lifestyle Factors in Breast Cancer-Related Outcomes

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

Interventions

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Lorenzo Cohen · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-13

Primary Completion

2030-12-31

Completion

2030-12-31

FDA Drug

Yes

Countries

• United States

Study Locations