Watchful Living: A Lifestyle Intervention for Black Prostate Cancer Patients on Active Surveillance and Their Partners

Baseline Visit:

If you agree to take part in this study, the following procedures will be performed at your
baseline (first) visit:

- You will complete a computer-based questionnaire about your age, education, social
status, health status, mood, diet, level of physical activity, and quality of life. The
questionnaire should take 45 minutes to complete.

- Blood (about 2 teaspoons) will be drawn to measure inflammation in the body that may be
linked to health problems, such as diabetes and high levels of cholesterol.

- You will be given a pedometer which is a small device worn on the hip that counts the
number of steps you have taken each day.

- You will complete a physical fitness test. During this test, your upper and lower body
strength and endurance will be measured. Among other tests, you will used a hand grip to
test your upper body strength, walk about 400 meters at a fast pace, and be asked to sit
down in a chair and stand up as many times as possible within a certain amount of time.
This fitness test should take about 15 minutes to complete.

- You will be given a blinded accelerometer. An accelerometer is a small device that is
worn on your hip that measures the amount of physical activity you do. However, a
blinded accelerometer means that you will not be able to see the results of the
accelerometer, so you will not know how much physical activity the accelerometer has
measured. You will be given a self-addressed prepaid envelope to return the
accelerometer to the study staff after you have worn it for 7 days.

Home-Based Physical Activity Program:

During your baseline study visit, you will also receive an exercise plan and printed
materials, which will include instructions for walking (or other moderate-intensity
activities if walking is difficult for you). These are activities that you can do on your own
at home.

After your baseline visit, you and your partner will receive 10 telephone coaching calls
lasting about 45-60 minutes each. Coaching calls will occur every week during Month 1, every
2 weeks during Month 2, and every month during Months 3-6. A health coach will discuss
physical activity and diet-related questions or concerns with you and your partner.

You may choose to stop receiving coaching calls at any time. If you choose to stop receiving
coaching calls this will not impact your ability to continue participation in the study.

Nutrition Counseling:

You and your partner will complete 2 nutrition counseling sessions with an MD Anderson
registered dietitian. The first session will occur in-person at your baseline visit. The
second session will occur before Month 3 over the phone at a time that is convenient for you
and your partner. During nutrition counseling, you will discuss goals, objectives,
lifestyles, and current eating habits with the dietitian.

Study Visits:

About 3 and 6 months after the baseline visit:

- You will complete the computer-based questionnaires.

- You will be given an accelerometer that will measure the amount of physical activity you
do over the next 7 days. For Month 3 the device will be mailed to you. You will be given
a self-addressed prepaid envelope to return the accelerometer to the study staff after
you have worn it for 7 days. For Month 6 you will receive the device 1 week before and
return it at your Month 6 visit.

- Blood (about 2 teaspoons) will be drawn to measure inflammation in the body that may be
linked to health problems, such as diabetes and high levels of cholesterol (Month 6
only).

- You will complete a physical fitness test (Month 6 only).

Some participants may be invited to participate in a group discussion called a focus group
about two months after the Month 6 visit. The focus group will be made up of 10 study
participants, and will be led by a study staff member who will ask questions about how you
feel in general and what you thought about the study. This focus group may last up to 2
hours.

The focus group will be audio recorded and then transcribed (written down) without your name
or any other identifying information. The digital audio files will be destroyed after they
are transcribed.

Length of Study:

Participation in this study for most participants will be over after the study visit at Month
6, but may last up to a total of 8 months for those who participate in the follow-up focus
group.

Inclusion Criteria:

1. Self-identify as black or African American (patient)

2. Be greater than 18 years of age (patient and spouse or intimate partner)

3. Have clinically localized prostate cancer diagnosed within 6 to 24 months prior to
study enrollment (patient)

4. Be eligible to undergo active surveillance or be undergoing active surveillance
(patient)

5. Enroll with a spouse or intimate partner (patient)

6. Be overweight or obese based on body mass index greater than or equal to 25 (patient)

7. Be ready and able to be physically active, as determined by a physician (letter from a
physician or nurse practitioner) (patient)

8. Not participate in another physical activity, diet, or lifestyle program (patient)

9. Have a valid home address and telephone number (patient)

10. Enroll with a spouse or intimate partner with prostate cancer on active surveillance
(spouse or intimate partner)

Exclusion Criteria:

1. Have an active noncutaneous malignancy at any site (patient)

2. Had prior radiation therapy for treatment of the primary tumor (patient)

3. Have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation
therapy during the study period (patient)

4. Are enrolled in another active surveillance protocol (patient)

5. Participated in formative focus groups for this study (patient and spouse or intimate
partner)