The Role of Lifestyle Factors in Breast Cancer-Related Outcomes

Baseline Visit:

If you are found to be eligible and you agree to take part in this study, you will come in to
the clinic for the baseline study visit, which will take place before your first radiation
therapy visit. During the baseline visit, you will be asked to fill out questionnaires about
your sleeping habits, how you have been feeling, diet, exercise, and the general quality of
your life. This should take about 60-80 minutes. You will be given a hand held computer to do
this unless you prefer a paper copy. All follow-up questionnaires will be delivered
electronically, but you can be given paper copies if needed. You will be asked to create a
username and password for use on the password-protected study website. All information you
enter into this website is encrypted and stored on institutional servers to protect your
privacy. You will be able to use this website to contact the study staff, access information,
schedule appointments, and so on. You will be taught how to use the website in your first
orientation visit and any technical support will be available upon request.

You will have an electrocardiogram (ECG - a test to measure the electrical activity of your
heart), a body composition scan (called a dual-emission x-ray absorptiometry [DEXA] scan) to
measure your body-fat level, a brief 30-second strength tests of both your upper and lower
body, and fitness testing (which is performed on a treadmill or stationary bike). This should
take up to 90 minutes total. Women who are able to become pregnant will have a urine
pregnancy test performed before the DEXA scan. A DEXA scan has about 1/10 the radiation dose
of a standard x-ray. If you are prescribed a DEXA by an outside physician or for some other
reason are getting a DEXA, please let us know as to avoid excess scans. If you are pregnant,
you will not have DEXA scans.

At every study visit, your height and weight will be measured and any swelling in your arms
will be measured with a device called a perometer. This device uses a sensor to measure the
size of your arm. Your arms will be measured one arm at a time. You will insert your arms
into a tube-like structure as the sensor slides up and down. This will take only a few
minutes and is will not cause any pain.

Blood (about 6 tablespoons) will be drawn for tests to measure hormones and your immune
system responses. This should take about 15 minutes. You will need to fast for 12 hours
before this blood draw. You will be provided with healthy snacks after your blood draw.

Saliva Testing:

The day after your baseline visit (the day you enrolled), you will be asked to provide saliva
samples to measure the level of cortisol (a stress hormone). These saliva samples will be
collected 4 times a day for 3 days in a row. You will be asked to collect the samples when
you first wake up, about 45 minutes later, about 10 hours after waking, and then at bedtime.
To collect each saliva sample, you will chew on a cotton ball for a few seconds and then put
the cotton in a small plastic tube. You will write down the times at which you took these
samples. You will then mail the samples back to MD Anderson in postage-paid envelopes that
will be provided to you. The tubes will also be provided at no cost to you. These saliva
samples will be destroyed after being studied.

Fitness Testing:

You will also wear an accelerometer (a pedometer-like instrument that records activity)
clipped to your waistline, for 5 days. The accelerometer will record information about your
movements.

Dietary Assessments:

Within 2 weeks of your consent date, you will be contacted by telephone on 3 random days for
a dietary recall. A trained nutritionist employed by the Arizona Cancer Center Behavioral
Measurements Assessment Laboratory will be making this call and will ask you about the foods
and beverages you have consumed in the last 24 hours. You do not need to change anything
about the way you eat for this, and you will not know exactly when they will call. You will
receive a phone call from study staff if they are unable to reach you.

Study Groups:

After your baseline visit, you will be assigned to 1 of 2 groups:

- Group 1 will take part in a Comprehensive Lifestyle Change Program that consists of
intervention sessions (described below).

- Group 2 will take part in the Assessment-Only Program and only take part in the
follow-up visits (described below).

Neither you nor the study staff can choose which group you are assigned to.

Intervention Sessions (Group 1 Only):

If you are assigned to Group 1, you will first attend an orientation visit where you will get
to know everyone who will work with you during the study. Here you will learn how to use the
website, schedule your own appointments, and log your behaviors in the website. You will then
have 3-5 days of intervention sessions per week over the course of your radiation treatment.
The sessions will offer a variety of instruction and counseling including: nutritional
coaching (one session per week); behavioral therapy (one session per week); yoga and
meditation practice (2 sessions per week); resistance training (2 sessions per week); and a
weekly meal sharing and cooking class. You will also be scheduled for a grocery store tour.
Each session will take between 1 and 3 hours, depending on that day's combination of
activities. Each session will include up to 5 study participants and a session leader, but
some sessions may be conducted one-on-one. All counseling sessions will be done one-one-one.

You will also be asked to participate in 30-60 minutes of supervised and/or unsupervised
aerobic exercise up to 6 days a week. If you choose to participate in classes at a local gym,
for which we will offer memberships, this will count toward your aerobic training. We will
also provide transportation from the clinic if needed.

After the end of radiation therapy, you will also have either phone or computer-based
meetings up to 1 time a week for 6 months, and then 1 time a month for 6 more months with the
study psychologist. The meeting times are on a flexible schedule. If you do not have a
computer and/or internet access, these will be provided to you while you to be used for study
purposes until the 12 month follow-up when it will need to be returned to the study
coordinator.

You will have 2-hour face-to-face meetings at all of your follow-up appointments during the
first year after completing radiation therapy.

You will be assigned a study coach for each part of the intervention program:

Physical activity: A coach will work with your individual fitness level to create an exercise
program for you. Coaching on strength training may be done during or after you finish
radiation therapy, and you will be given a pedometer and elastic workout bands to help you
practice at home. You will be provided with a gym membership at no cost for up to one year
after radiation therapy is over, and you will work with community-based coaches. You will
also be given a voucher for a local athletic shoe store. After you finish radiation therapy,
you will be contacted at least once a week by your outside-community coach. You will be asked
to use your profile on the study website to track your exercise.

Diet/Nutrition: You will work with a dietician every week to learn how to shop and cook
during radiation therapy. You will be asked to use your profile on the study website to track
your eating habits. You will be given cookbooks and a blender along with recipes for the
blender and kitchen items such as a magnet, grocery tote bag, and water bottle.

Mind-body practice: You will meet once a week with a mind-body instructor. During these
meetings, you will be instructed in a seated meditation and a movement-based practice. You
will be asked to use your profile on the study website to track your mind-body practice. You
will be given a yoga mat to facilitate your practice.

Social support/social network: You will meet with a psychologist once a week during radiation
treatment. You will take part in cognitive behavioral therapy to help support the behavior
changes. You will receive a welcome box including helpful items such as a journal, along with
the book Anticancer. During this therapy, the psychologist will work with you to help you
recognize the barriers that may keep you from changing your behavior, so that you can
understand how to develop new habits. Although the psychologist will be calling you once you
have completed your treatment, you can request to have additional consults with any one of
the study personnel at any time you would like. You will also have an opportunity to
voluntarily participate in a Facebook group for program members and staff only, designed to
increase sharing of information, recipes, experiences, etc. If you choose to belong to this
virtual group, you can communicate with others in the program in addition to staff members.

Smoking cessation counseling (if needed): If you smoke, you will be offered smoking cessation
treatment from the MD Anderson's Tobacco Treatment Program.

Intervention sessions will be recorded in order to protect you and ensure the program is
delivered as safely and effectively as possible. If there is any video recording, it will be
only to capture your instructor. Most recordings will only be audio and will again be
directed at your instructor or counselor. Once the recordings have been reviewed they will be
destroyed.

We may use and publish testimonies, quotes, or program experiences as part of future
publications, books, and other media outlets such as radio programming and newsletters, but
your name will not be associated with the quote unless we get separate authorization from
you. This authorization will be obtained using MD Anderson's institutional HIPAA
Authorization form.

Follow-up Visits After Finishing Radiation Therapy (Both Groups):

At the end of radiation treatment, at 3, 6, 12, 18, and 24 months after the end of radiation
treatment, and then once a year for up to 3 years after that, you will be asked to return to
the clinic for follow-up visits. These visits will take place at the same time as your
medical follow-up visits at MD Anderson.

During these follow-up visits, the following tests will be performed for all participants:

- You will fill out a set of questionnaires and fitness measures that was very similar to
the ones you filled out at baseline. You will be asked to fill out questionnaires about
your sleeping habits, how you have been feeling, your diet and exercise habits, and the
general quality of your life. This will take about 60-80 minutes to complete.

- You will also have an ECG that will take no more than 20 minutes to complete.

- Blood (about 6 tablespoons) will be drawn to measure hormones and your immune system
responses. You will need to fast for 12 hours before the blood draw.

- You will be asked to provide 4 saliva samples a day for 3 days in a row. You will follow
the same process as you did for the baseline saliva samples.

- You will wear an accelerometer 24 hours a day for 5 days in a row to collect the same
data as before.

- You will be receiving 3 calls within 2 weeks of each timepoint for your dietary recalls.

After completing the questionnaires, saliva sample collection, and accelerometer
participation, you will return all materials to the research staff, using a prepaid mailing
envelope. If you fill out the questionnaires electronically, these do not need to be printed
and returned.

You will have follow-up DEXA scans to measure body composition at the end of your radiation
treatment, and then 6, 12, and 24 months later. Women who are able to become pregnant may
have urine pregnancy tests before each DEXA scan. If you are pregnant, you will not have DEXA
scans during your pregnancy.

Length of Participation:

Your participation on this study will be over about 5 years after the end of radiation
therapy.

Inclusion Criteria:

1. Women with Stage II or III breast cancer that will be scheduled to undergo a 4 to
6-week course of radiotherapy.

2. Participants must be able to read, write, and speak English.

3. Participants must be at least 18 years of age.

4. Participants must be oriented to person, place, and time.

5. Participants must also meet 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.

6. Participants must have a BMI of 24.45 or higher as assessed in the medical record.

Exclusion Criteria:

1. Patients with a recurrent breast cancer diagnosis.

2. Patients with another primary cancer diagnosis within 5 years of consent, not
including non-melanoma skin cancers.

3. Patients who have any major psychiatric diagnoses or thought disorder (e.g.
Schizophrenia, Bi-polar disorder, Dementia).

4. Patients with communication barriers (e.g., hard of hearing).

5. Patients with extreme mobility issues (e.g. unable to get in and out of a chair
unassisted).

6. Patients with poorly or uncontrolled diabetes in the opinion of the physician(s).