Trial Information

Social Cognitive Theory and Physical Activity After Endometrial Cancer

Women who have been successfully treated for endometrial cancer will be invited to
participate in the study. After you agree to participate you will be asked questions about
your physical activity to make sure you are eligible. You will only be allowed to
participate in this study if your physician feels it is safe for you to engage in moderate
physical activity, so you will be asked to have him or her complete a form about your health
conditions. Information about you cancer and treatment history will be collected from your
medical records as part of the study.

If you agree to take part in this study, you will come to M. D. Anderson for study visits
twice at the beginning of the study. If needed, the activities for these first 2 visits can
be combined into 1 visit, though it will mean that the single visit will take a little
longer than each of the 2 visits. After the first visit, you will be asked to return after
2, 4, and 6 months. Each visit will take about 2 hours. Three (3) months and 6 months after
the last visit, you will be called to answer questions about your physical activity. It
will take about 10 minutes to answer the questions. In case you cannot be reached by phone,
the questionnaires will be mailed to you. You will be asked to mail the questionnaire back
in with a pre-paid addressed envelope.

At the first visit you will complete questionnaires about your quality of life, medical
conditions, and how physically active you are currently and have been in the past. The
questionnaires will take about 45 minutes to complete. A baseline electrocardiogram (ECG-a
test to measure the electrical activity of the heart) will be performed. If your ECG test
is not normal you will be informed. You will practice using the exercise bicycle that will
be used in the fitness testing at the later visits. You will be asked to provide a saliva
sample by placing a cotton roll in your mouth until it is saturated and then placing it back
in a plastic vial without using your hands. This sample will be for practice and will be
discarded.

You will also be given an ActiGraph to wear for 5 days. This is a small light device that
you wear on your waist during the day. It records how active you are. You will also be
given a handheld computer that you will use for 5 days to answer questions about physical
activity. The computers are small (about 4-1/2 by 3 inches) and light (about 4 1/2 ounces).
The computer will prompt you to enter information up to 8 times a day. Answering these
questions will take up to 5 minutes. You will be asked to return the Actigraph and the
computer on your second visit.

After 5 days, you will come back to M. D. Anderson for your second study visit. During this
visit, you will be asked to complete questionnaires about physical activity that will take
about 1 hour. You will have an electrocardiogram (ECG--a test to measure the electrical
activity of the heart) performed. You will perform a fitness test, in which you will ride a
stationary bicycle while your heart rate, blood pressure, and respiration (breathing) are
monitored. You will also be asked to complete two tasks on a computer. After the second
visit, you will again use the handheld computer and wear an Actigraph for 5 days. You will
also be given 10 vials with a container bag and instructions on collecting saliva samples.
You will be asked to provide saliva samples 5 times per day for 2 consecutive days.

During your second visit, you will meet with an exercise physiologist, a specially-trained
health care professional who will design a personalized exercise program for you, that will
involve walking (up to 30 minutes) on most days of the week. If walking is difficult or
painful for you, another form of exercise will be substituted. In addition to receiving a
personalized exercise program, you will also receive telephone counseling between your
visits to M. D. Anderson and printed materials. Both will provide information and support
for your exercise program. The telephone counseling calls will take place once a week
during the first 2 months, every other week during Months 3 and 4, and once a month during
Months 5 and 6. The phone counselor will talk to you about your exercise program and how it
is working for you. The telephone calls will take place at a time that is convenient to
you, and will take about 15-20 minutes each time. Some of these telephone counseling calls
may be audiotaped, so that the counselors' supervisors can make sure the counseling is done
correctly.

During each of the 2-month, 4-month, and 6-month clinic visits (Visits 3, 4, and 5), you
will do another fitness test, and any necessary adjustments to your exercise program will be
made. This means that if the goals for exercise were set too high or too low, how often the
exercise occurs or how long each exercise session lasts will be changed. For example, if
the exercise physiologist first recommended that you walk for 15 minutes a day 5 days a
week, but you report that you can't walk for 15 minutes, the length of the walk may be
reduced. You will also fill out the questionnaires and do the tasks on the computer at these
visits. You will complete a brief (5 minutes) program evaluation. You will also be asked
to answer questions on the handheld computer for 5 days before and after each these visits.
You will also be asked to wear the Actigraph for 5 days before and after each of these
visits. At the last visit, you will also be given 10 vials with a container bag and
instructions on collecting saliva samples. You will be asked to provide saliva samples 5
times per day for 2 consecutive days. The study staff will give you a prepaid mailing
envelopes so you can return the computer, the Actigraph, and the package of vials to them by
mail, after the last 5-day period.

This is an investigational study. Up to 326 participants will be enrolled for this study.
For the pilot phase, which has been completed, 22 endometrial cancer survivors and 37
comparison participants with no history of cancer were enrolled. For the main phase of the
study, for which you are enrolling, up to 267 endometrial cancer survivors will be enrolled.
All will be enrolled at M. D. Anderson.