Comprehensive Lifestyle Change To Prevent Breast Cancer

Baseline Visit:

If participant agrees to take part in this study, participant will have a baseline visit so
researchers can measure how participant has changed before and after taking part in the
prevention program. Participant will come to the clinic for some of these tests/procedures
and others will be completed at home.

At the clinic:

- Participant will complete questionnaires electronically on a hand-held computer about
participant's sleeping habits, how participant has been feeling, diet, exercise, and the
general quality of participant's life. It should take about 30 minutes to complete.

- Participant will have strength tests of participant's upper and lower body, lasting no
more than 30 seconds. During these tests, participant will sit in a chair and then stand
up and sit down again.

- Participant will sit and stand as many times as participant can in 30 seconds.
Participant will also be asked to perform as many bicep curls as participant can in 30
seconds while holding a 5-pound weight.

- Participant will have a DEXA scan to measure participant's body-fat level. If
participant can become pregnant, urine will be collected for a pregnancy test. If
participant is pregnant, participant will not have a DEXA scan.

- Blood (about 3 tablespoons) will be drawn for tests to measure hormones and
participant's immune system responses. Participant will need to fast (have nothing to
eat or drink except water) for 12 hours before this blood draw. Participant will be
provided with healthy snacks after participant's blood draw.

At home:

- Participant will be given an at-home kit to collect a stool sample to measure
participant's gut microbiome (the types of bacteria in participant's stomach and
intestines). This testing will also include genetic testing of the micro-organisms (such
as bacteria) found in participant's stomach and intestines. Participant will not receive
the results of this testing. Participant will be given instructions on how to return the
stool sample back to the Human Genome Sequencing Center at Baylor College of Medicine.

- Participant will complete a 6-minute walking test at the clinic. During this test,
participant will be asked to quickly walk down a hallway of at least 100 feet in length
or participant will walk on a treadmill for 6 minutes. Researchers will measure how far
participant can walk in 6 minutes.

- Participant will be given an accelerometer to wear for 5 days. The accelerometer
measures how many steps participant takes each day. At the end of 5 days, participant
will send the accelerometer back to the study staff in a self-stamped, pre-paid envelope
that participant will be given.

- Saliva will be collected 4 times each day (when participant wakes up, 45 minutes after
waking up, 10 hours after waking up, and at bedtime) for 3 days in a row to measure
participant's cortisol levels. Cortisol is a hormone in the body related to stress. To
collect the saliva, participant will chew on a cotton ball for a few seconds and then
put the cotton in a small plastic tube (which participant will be given). Participant
will write down the times at which participant took these samples and then send the
samples back to the study staff in a self-stamped, pre-paid envelope. The saliva samples
will be destroyed after being tested.

The baseline visit will last about 1 day or can be split into 2 half-days.

Study Groups:

Participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This
is done because no one knows if one group is better, the same, or worse than the other.

- In Group 1, participants will take part in the cancer prevention program for 26 weeks.

- In Group 2, participants will not have any intervention for about 6 months but will
continue to have the study visits described below. After 6 months, participant will be
able to take part in the cancer prevention program and be part of the study again for a
similar length of time. Participant will take part in the cancer prevention program for
an additional 6 months.

Group 1 Participants Only:

If participant is in Group 1, participant will take part in a cancer prevention program
(called mobile integrative oncology prevention program). As part of the cancer prevention
program, participant will have online sessions counseling participant in the areas of diet,
exercise, mind-body practice, and behavioral counseling over the course of up to 12 weeks.
Participant will first have a day-long session, or two half days, in person so participant
can meet the intervention team. After Week 12 of counseling, an additional 3 dietary,
exercise, and mind-body sessions may be scheduled over the next 3 months.

Each week participant will have 1-2 physical activity sessions, 1-2 nutrition and diet
sessions, and 1-2 mind-body practice sessions (such as yoga) that should last about 60
minutes each; for a maximum of 12 sessions of each over 12 weeks. Participant will also have
1 behavioral counseling session each week for up to 26 weeks.

The intervention programs will be provided by a licensed professional (such as a personal
trainer, dietician, or yoga instructor). Each session will be video and audiorecorded.

Participant will be given the contact information for the personal trainer, dietician,
behavioral counselor, and/or yoga instructor in order to answer any questions or concerns
participant may have during the study.

Participant will be given a link to a study-specific website in which participant will set up
a profile online. The study staff will help participant set up this account using
participant's email address. If participant does not have an email address, an account will
be created for participant. This website will be a "hub" for this study. Participant will use
the website to track participant's diet, exercise, and mind-body exercises (described in more
detail below). Participant's profile will be password-protected. The website will have
digital copies of the educational information participant will receive throughout the
program.

If participant smokes, participant will also be referred to MD Anderson's Tobacco Treatment
Program.

Physical Activity:

During each online session, a personal trainer will advise participant on types of exercises
participant should be performing during the week. A personal trainer will work with
participant's individual fitness level to create an exercise program for participant.
Participant may be asked to exercise with the trainer during these sessions. The trainer can
help participant modify the exercises, if needed. Participant should exercise 3-5 times each
week for about 30-60 minutes each time with varying degrees of intensity. The personal
trainer will tell participant how often to exercise and how intensely participant should be
exercising.

Before exercising, participant will need to receive permission from participant's regular
care doctor (a medical release). If any medical issues arise that may affect participant's
safety while performing physical activity, participant will need to be re-evaluated by
participant's doctor and get a new medical release.

Participant will use participant's profile on the study website to track participant's
exercise.

Diet/Nutrition:

During the diet/nutrition sessions, participant will be taught to shop and how to cook a
mostly vegetarian diet. The dietician will tell participant about healthy foods, cooking
techniques, and which restaurants and places to shop are considered healthy.

Participant will be asked to use participant's profile on the study website to track
participant's eating habits.

Mind-Body Practice:

During these sessions, participant will be taught about meditation techniques (such as
deep-breathing exercises) and yoga-based practices. Participant should practice these
techniques for about 1 hour every day.

Participant will be asked to use participant's profile on the study website to track
participant's mind-body practice.

Behavioral Counseling and Social Support:

As part of behavioral counseling and social support, participant will be given workbooks on
paper and online to work on goal-setting and to address barriers participant faces in
participant's day-to-day life. Participant will meet with a counselor 1 time each week online
or by phone for 26 weeks. Participant may also join a webinar (a seminar that is held online)
1 time every month that is hosted by a member of the study staff. Each webinar will cover a
special topic related to counseling and social support and will involve interactive
discussions.

Participant will also have an opportunity to voluntarily take part in a Facebook group for
program members and staff only, designed to increase sharing of information, recipes,
experiences, and so on. If participant chooses to belong to this virtual group, participant
can communicate with others in the program in addition to staff members. Participant does not
have to take part in the Facebook group to take part in this study.

Follow-up Visits:

If participant is in Group 1, participant will have follow-up visits after participant has
completed 12 weeks of the cancer prevention program and then again about 26 and 52 weeks
after that.

If participant is in Group 2, participant will have a follow-up visit at about 12 and 26
weeks after participant was assigned to Group 2. If participant decides to take part in the
cancer prevention program, participant will repeat the baseline visit above, take part in the
program, and then have follow-up visits at 12 weeks after the program and then again about 26
and 52 weeks after that.

During these follow-up visits, participant will complete the same tests/procedures performed
at the baseline visit. Participant will only have a DEXA scan at 26- and 52- weeks. In
addition, participant will complete questionnaires online on a desktop, laptop, tablet, or
smartphone about what participant has eaten recently.

After the 52-week follow-up time point, participant will take part in an interview about
participant's experience in the study and in making lifestyle changes. This interview will
last about 30-60 minutes.

Length of Study Participation:

Participant's active participation in this study will be over after participant completes the
follow-up visits.

Inclusion Criteria:

1. Able to read, write, and speak English.

2. Women who are 18 years of age or older, but premenopausal.

3. A BMI >/= 25 as assessed in the medical record and have intact breasts and ovaries.

4. Able to provide informed consent to participate in the study.

5. Meet all the following criteria related to lifestyle: a) consume less than 3 servings
of vegetables (excluding any fried servings) and 1 serving of fruit (not including
juice)/day; b) engage in less than 150 minutes moderate/vigorous intensity 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); c) engage in a
mind-body practice less once per week.

6. Able mentally and physically to participate in interventions in this study (Note: If
there are one or more positive responses to the Physical Activity Readiness
Questionnaire (PARQ), then a physician-release for exercise is required prior to
obtaining consent).

Exclusion Criteria:

1. Any personal history of cancer, including DCIS and not including non-melanoma skin
cancers;

2. Any major thought disorder (e.g., schizophrenia, dementia).

3. Communication barriers (e.g. hard of hearing).

4. Poorly or uncontrolled diabetes in the opinion of the physician(s).

5. Extreme orthopedic or mobility issues (e.g., unable to get in and out of a chair
unassisted).

6. Being pregnant or planning on becoming pregnant within the next year.

7. Contemplating any new pharmacologic/hormonal or prophylactic surgical intervention
within the next year (Note: Individuals taking tamoxifen, arimidex or other hormonal
prevention strategies at time of consent will be eligible).