iMETX (Individualized Metabolic RX): a Pilot Study

Objectives The investigators hypothesize that developing an individualized and dynamic
exercise intervention (iMETX) that accounts for factors of the built environment will be
feasible for breast cancer patients following primary treatment. This pilot study will assess
the feasibility and provide preliminary estimates of effectiveness of the environmental
intervention for increasing the energy expenditure and energetic capacity of breast cancer
patients. The investigators will also explore patient feedback with this intervention and
changes in levels of fatigue and quality of life. Experience and data from this initial pilot
study will be used to refine the intervention and design subsequent studies to test its
effectiveness.

Primary objective Evaluate the feasibility of an individualized, dynamic, environmental
physical activity intervention for early stage breast cancer patients following primary
treatment.

Secondary objectives

1. Determine a preliminary estimate of effect size of the environmental intervention on
energetic capacity (power envelope) as measured by Power Protocol-B

2. Determine a preliminary estimate of effect size of the environmental intervention on
average daily EE as measured by a wearable hybrid GPS/accelerometer physical activity
monitor

3. Determine the effect of the environment intervention on the physical parameters of BMI
and lean body mass

4. Determine the effect of the environmental intervention on patient reported fatigue and
quality of life

5. Determine the persistence of changes in average daily EE after the intervention is
complete (i.e., when individual movement tasks are no longer suggested).

6. Obtain formal and informal patient feedback throughout and after the intervention to
assess satisfaction and perceptions of feasibility

7. Assess safety

Exploratory objectives Blood samples will be collected prior to and following the
intervention and banked for future correlative studies, including the following: inflammatory
cytokines (high sensitivity C reactive protein and interleukin 6), adipokines (adiponectin
and leptin), sex hormones (estradiol, estrone, testosterone, and sex hormone binding
globulin), and telomere length. In addition the invstigators will explore correlations of
built and social environment characteristics and psychosocial characteristics with
pre-intervention and changes in energy expenditure.

Inclusion criteria

1. Age ≥ 18 years

2. Diagnosis of DCIS or stage I, II, or III breast cancer

3. Completion of all primary therapy (with the exception of ongoing endocrine or
trastuzumab therapy), including surgery, radiation, and/or chemotherapy greater than 4
weeks prior to study enrollment

4. Body weight less than 350 lbs., as dictated by the weight limit for DXA scanner

5. Regular access to a smart phone or computer

Exclusion criteria

1. Any condition precluding exercise, including: NYHA class II, III, or IV congestive
heart failure, uncontrolled angina, myocardial infarction in the prior 12 months,
orthopedic surgery in the previous 6 months or plans for orthopedic surgery during the
study period, chronic pulmonary conditions such as uncontrolled asthma (symptoms > 2
days/week) or dyspnea requiring oxygen, symptomatic peripheral vascular disease,
symptomatic anemia, uncontrolled psychiatric conditions such as schizophrenia, or any
other comorbidity that would interfere with the ability to complete and comply with
the study protocol in the opinion of the investigator

2. Locally recurrent or metastatic breast cancer

3. Diagnosis of other active malignancy. Prior treated malignancies in addition to breast
cancer are acceptable.

4. Pregnancy

5. Requirement of assistive devices (e.g., cane) for ambulation

6. Plans for moving to a new home or workplace during, pre-, or post-intervention period

7. Elective surgery anticipated during, pre-, or post-intervention period (e.g., breast
reconstruction)

8. Inability to comply with the study procedures