Trial Information

Biobehavioral Effects of Relaxation for Women With Breast Cancer Undergoing Radiotherapy

During the first visit, you will fill out questionnaires that ask about your sleeping
habits, how you have been feeling, and the general quality of your life. This should take
about 60-80 minutes.

Every day for the next 7 days, you will fill out a diary about your sleep. You will also
wear an "actigraph" wrist watch 24 hours a day for these 7 days. The watch will collect
data about your physical activity and sleeping habits.

You will also have an electrocardiogram (ECG - a test to measure the electrical activity of
your heart) which will last about 10 minutes.

Study Groups:

After your first visit, you will be randomly assigned (as in the roll of dice) to 1 of 3
groups:

- Group 1 will take part in one type of relaxation program.

- Group 2 will take part in another type of relaxation program.

- Group 3 will not take part in either program but will complete some of the follow-up
procedures. Participants in this group will be given the option to take part in one of
the two forms of relaxation (off study) after they finish their last questionnaire
packet.

You will have about a 1 out of 3 chance of being assigned to each group. The groups are
randomly assigned, but it is also based on other factors such as your age and the status of
the disease.

Sessions:

Groups 1 and 2:

You will take part in 3 sessions each week for the 6 weeks of radiation therapy, or 4-5
sessions each week for 4 weeks if your radiation therapy lasts only 4 weeks. You can choose
any weekday (Monday through Friday). Each session should last about 60 minutes.

The sessions will be taught by an experienced, trained instructor, usually in groups of 2-5
participants. The movements are designed to be easy to follow. You will be able to work at
your own pace.

Each session will be audio and video recorded. This is so the researchers can keep track of
the quality of the sessions. The audio and video files are digital and will be deleted
after all the data are studied.

Women in Groups 1 and 2 will be randomized to a maintenance intervention arm or a usual
contact arm after the end of radiotherapy. If you are randomized to the maintenance
intervention arm you will receive telephone counseling once a month after the end of your
radiotherapy. You will also receive booster sessions once every 3 months post-radiotherapy,
or at least when you come for your follow-up appointments.

Groups 1 and 2:

During the sessions, you will do simple stretching exercises, specific breathing skills, and
guided relaxation. You will be asked to try and practice once a day for 12 months. You
will be provided a DVD and an audio CD to help with your practice when you are not at the
hospital.

Questionnaires and Study Procedures:

Groups 1 and 2:

Before your first session of the week except for week 1, Groups 1 and 2 will fill out a
questionnaire about the relaxation program. This should take about 1-2 minutes.

During the middle of your radiation treatment period, you will have an ECG recorded before
and after your classes. Each ECG will last about 10 minutes.

All Groups:

During the middle of your radiation treatment period, you will fill out a questionnaire that
asks about any symptoms you may be having. This should take about 15 minutes. You will also
have an ECG.

During your last week of radiation therapy, and at 3, 6, and 12 months after your radiation
therapy ends, you will fill out a set of questionnaires. The questionnaires will be mostly
the same as at your first study visit. This should take about 60-80 minutes. You will also
have an ECG at these times.

Questionnaire packets will be mailed to your home by the research staff. After completing
the questionnaires, you will return the completed questionnaire packet to the research staff
via a pre-paid mailing envelope.

Every day for 7 days in a row, after every time you fill out the questionnaires, you will
fill out another sleep diary. During these 7-day periods, you will wear an actigraph watch
24 hours a day to collect the same data as before. Each time, you will mail the actigraph
watch back to MD Anderson in postage-paid envelopes that will be provided to you.

If your questionnaire responses show that you may be having emotional difficulties or
depression, you will be provided with names of mental health providers in case you would
like to receive mental health screening.

All participants will be asked not to do any other stretching/relaxation practices during
the study.

Saliva Testing:

You will provide 4 saliva samples per day for cortisol testing on the following schedule:

- for 3 days before radiation therapy begins

- for 3 days in the last week of radiation therapy

- for 3 days in a row, 3 months after radiation therapy ended

- for 3 days in a row, 6 months after radiation therapy ended

- for 3 days in a row, 12 months after radiation therapy ended

To provide a 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 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.

Length of Participation:

Your study participation will be over after you fill out the questionnaires 12 months after
radiation therapy.

This is an investigational study. The relaxation programs are being compared for research
purposes only.

An "assessment" is any time you complete a set of scheduled activities for this study, such
as tests and questionnaires.

Up to 600 patients will take part in this study. All will be enrolled at MD Anderson.