Trial Information

Patient Knowledge of Pacemaker/Implantable Cardioverter-Defibrillator-Phase II

If you agree to take part in this study, you will complete 3 sets of questionnaires (at the
beginning of the study, at 2-months and at 4-months) which will be sent to you and returned
by you through the mail. This will not require you to travel to M.D. Anderson. In addition
to the questionnaires, you will also complete 2 follow-up phone interviews.

Questionnaires:

The first set of questionnaires will be mailed to your home. The questionnaires will ask
questions about your anxiety level and how much you know about pacemakers or implantable
cardioverter-defibrillators. There will also be questions about your gender, age, ethnicity,
and race. The questionnaires will take about 25 minutes to complete. When you are finished,
you will mail the questionnaires to the study staff. An envelope with pre-paid postage will
be provided.

Educational Packet:

After you have completed the questionnaires, you will receive an educational packet in the
mail. The packet will have a DVD or a video (depending on whether you tell us you have a
DVD player or a VHS player) with information on medical devices, device recall information
(when and why certain devices have been recalled in the past), a list of on-line resources
and benefits of routine follow-up.

Phone Interview:

The study staff will call your home 1 week after you receive the educational packet for a
follow-up interview. A member of the study staff will review the packet with you. The phone
call will last about 20 minutes.

Additional Questionnaires:

Approximately 2 months and at 4 months after you complete the first set of questionnaires,
an additional set of questionnaires will be mailed to you. You will be asked to complete
the same questionnaires as you did in the first set. At 4 months an additional questionnaire
about the information in the educational packet and how useful it was to you will be
included. The questionnaires will take about 25 minutes to complete. When you are finished,
you will mail the questionnaires to the study staff. An envelope with pre-paid postage will
be provided.

Length of Study:

You participation on this study is complete once you have completed the additional
questionnaires.

This is an investigational study. Up to 104 patients will be enrolled in this study. All
will be enrolled at M. D. Anderson.