Trial Information

DAMES: Daughters And MothErS Against Breast Cancer

DAUGHTER AND MOTHER - FULL INTERVENTION STUDY:

Women who are overweight have a greater chance of developing breast cancer as they get
older, and also are at greater risk of developing more aggressive cancer. Researchers want
to study 3 different home-based diet and exercise weight loss programs and find out the
effect of the programs on body weight, quality of life, and other health-related factors.

If you and your mother agree to participate in this year-long research study, you will be
asked to sign this consent form and send it into our study office in the envelope provided.
As soon as the study staff receives these forms from both you and your mother, they will
contact you to schedule your first study visit.

First Study Visit:

If you live within 60 miles of the clinic, you will be asked to come in for an in-person
appointment that lasts about 1 hour. During this visit, the study staff will measure your
height, weight, blood pressure, and your waist (using a tape measure).

You will also be asked to have cardiopulmonary exercise testing, also known as a "stress
test." The purpose of this test is to check your fitness level. During this test, you will
pedal a stationary (exercise) bicycle. You will be asked to pedal at the same speed, as the
difficulty is increased every minute. It will feel like you are pedaling up a hill that
gets steeper and steeper. The test is stopped when you cannot pedal at the desired speed or
you become too tired to pedal.

To accurately measure your fitness level, the study staff will measure the air that comes in
and out of your mouth during exercise. You will be asked to wear a mouthpiece (similar to a
snorkel used in deep sea diving) which is connected to a tube that sends the air you breathe
out into a machine where it is tested. The exercise test will last about 8-12 minutes. As a
safety precaution, during the test the study staff will also monitor your heart rate using a
12-lead electrocardiogram (ECG--a test that measures the electrical activity of the heart).
This means that the study staff will place electrodes (sticky pads) at certain locations on
your body so that they can monitor how your heart responds to exercise.

If you do not live within 60 miles of the clinic, or if you do not or cannot report to these
medical centers, the study staff will send a study nurse to your house (or another location
easy for you to reach) to measure your height, weight, blood pressure, and your waist (using
a tape measure).

If the blood pressure measurement shows that your blood pressure is elevated (greater than
179/109), the study chair will need your personal doctor to say it is okay for you to take
part in the study.

Activity Monitor and Phone Interviews:

After your first study visit, you will be given an activity monitor and instructions to wear
it on your waistband or belt (like a pedometer), during the time you are awake, for 7 days
in a row. The activity monitor will record your daily activity. At the end of the 7 days,
you will be asked to return the activity monitor using a pre-addressed, postage-paid return
envelope that you will be given to you with the monitor.

You will also receive a food poster and survey guide after your first study visit. You will
use these to participate in 2 unscheduled telephone interviews within the next month. Each
interview will take about 30 minutes. At the beginning of the interview, the interviewer
will ask if the time is convenient for you, or if you need to reschedule the call for
another time when you are available. During these interviews, you will be asked questions
about your health and your diet and exercise behaviors.

Study Groups:

After both you and your mother have completed your surveys and the information from your
activity monitor has been received by the study staff, both you and your mother will be
randomly assigned as a team (like drawing names from a hat) to 1 of 3 intervention groups.
All 3 interventions will not start sooner than 6 months after your mother's cancer
diagnosis, to allow time for her to recover from treatment.

Standardized Materials Group:

If you are assigned to this group, you will be asked to exercise and to improve your diet to
the best of your ability. In order to do this, you will receive 7 sets of print materials
about diet, exercise, and other health information. These materials will be mailed every
6-7 weeks throughout the 1-year intervention period. After each mailing, you will be asked
to complete a short survey (16 questions) about the information you received and how useful
it was for you. You will be asked to return the survey in a prepaid, addressed envelope
that was sent with the materials.

Independent Tailored Intervention Group If you are assigned to this group, you will be asked
to exercise and to improve your diet to the best of your ability. In order to do this, you
will receive a personalized notebook of diet and exercise information, which will be mailed
to you at the start of the intervention. About every 6-7 weeks throughout the 1-year
intervention period, you also will receive 6 personalized newsletters that will also provide
you with more information. After each mailing, you will be asked to complete a short
survey (16-20 questions) about the information you received and how useful it was for you.
You will be asked to return the survey in a prepaid, addressed envelope that was sent with
the materials.

In addition, you also will be given the following equipment and supplies to help you
exercise and eat better:

- A pedometer, which is a small device worn just like the activity monitor that counts
the number of steps you take each day;

- An Apple Nike + iPod® Sport kit (including iPod) that will play music to exercise to
and record the time and distance you exercise;

- Food portion and fat information guides to help you make good food choices; and

- Logbooks that you will use to record what foods you eat and your exercise behaviors
while you are on study.

Partner-Assisted Tailored Intervention Group:

If you are assigned to this group, you and your mother, as a team, will be asked to exercise
and to improve your diets to the best of your ability. In order to do this, you will each
receive a personalized notebook of diet and exercise information, which will be mailed to
you at the start of the intervention. About every 6-7 weeks throughout the 1-year
intervention period, you also will receive 6 personalized newsletters, which will also
provide you and your mother with more information. After each mailing, you will be asked
to complete a short survey (16-20 questions) about the information you received and how
useful it was for you. You will be asked to return the survey in a prepaid, addressed
envelope that was sent with the materials.

In addition, you and your mother also will be given the following equipment and supplies to
help you exercise and eat better:

- A pedometer, which is a small device worn just like the activity monitor that counts
the number of steps you take each day;

- An Apple Nike + iPod® Sport kit (including iPod) that will play music to exercise to
and record the time and distance you exercise;

- Food portion and fat information guides to help you make good food choices; and

- Logbooks that you will use to record what foods you eat and your exercise behaviors
while you are on study.

These materials that you will receive will emphasize a "team approach" to weight loss, and
will encourage you and your mother to support one another. If you are assigned to this
group, you will be encouraged to talk with your mother regularly. The study will reimburse
you for up to 20 minutes/day of telephone calls between you and your mother. You will be
told how to submit these phone charges if you are assigned to this group.

Follow-up Interviews and Visits:

At both 6 months and 1-year after you start this study, you will have a telephone interview
with a member of the study staff. Each interview will last about 30 minutes, and will
involve the same information collected during the 2 interviews at the beginning of study
participation.

You will also be asked to take part in 2 more in-person visits (one at 6 months and another
after a year) that will be like the visits performed at the beginning of the study.

Up to 134 women (67 mother-daughter pairs) will take part in this multicenter study. Up to
34 mother-daughter pairs will be enrolled at M. D. Anderson, and the rest will be enrolled
at the Duke Comprehensive Cancer Center.