The Role of Lifestyle Factors in Breast Cancer-Related Outcomes

M.D. Anderson Cancer Center

Status

Active, not recruiting

Conditions

Stage III Breast Cancer AJCC v7

Stage IIIC Breast Cancer AJCC v7

Stage IIIA Breast Cancer AJCC v7

Stage IIIB Breast Cancer AJCC v7

Stage IIB Breast Cancer AJCC v6 and v7

Stage II Breast Cancer AJCC v6 and v7

Stage IIA Breast Cancer AJCC v6 and v7

Treatments

Other: Behavioral, Psychological or Informational Intervention

Behavioral: Exercise Intervention

Other: Quality-of-Life Assessment

Other: Best Practice

Other: Computer-Assisted Intervention

Other: Cognitive Intervention

Other: Counseling

Other: Questionnaire Administration

Other: Laboratory Biomarker Analysis

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02079662

2012-0112 (Other Identifier)

NCI-2014-02449 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

110 participants in 2 patient groups

Arm I (IO interventions)

Experimental group

Description:

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.

Treatment: