Trial Information

The Use of Light Therapy for Managing Sleep Disturbances in Patients With Advanced Cancer

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to one of two groups:

- Group 1 will receive one type of light therapy for 30 minutes every day for 14 days.

- Group 2 will receive a placebo light for 30 minutes every day for 14 days. The placebo
light is not designed to have any effect on your sleep.

You will not know which group you are in. After 14 days, both groups will begin receiving
the light therapy for another 14 days.

Litebook:

You will use a device called a Litebook to receive either the light therapy or the placebo
light for 30 minutes, within 2 hours of waking up every day. The Litebook is about the size
of a deck of cards. To use the Litebook, you will place it on a table within 2 feet of you
while you are sitting down. The Litebook will either deliver the light therapy or the
placebo light. You do not need to look directly into the Litebook and you can do usual
activities such as eating or reading while you are using it. The study staff will teach you
how to use the Litebook.

Study Diaries:

You will complete the following diaries at the end of each day of the 28-day study period:

- The light exposure diary about how much light you were exposed to.

- The sleep diary about your sleeping habits.

It should take about 5 minutes each day to make entries in the study diaries. You will
return the diaries to the study staff at 2 weeks and 4 weeks.

You will also wear a watch that will measure your activity level for 24 hours a day while
you are on study. You will return the watch to the study staff after you have completed the
study.

Questionnaires:

You will complete a questionnaire about any symptoms you are having from the light therapy
at the beginning of the study, at 1 week, at 2 weeks, and at 4 weeks. The questionnaire at 1
week can be done over the phone. It should take about 5 minutes to complete.

You will complete the following questionnaires at the beginning of the study, at 2 weeks,
and at 4 weeks:

- The Edmonton Symptom Assessment Scale. You will rate 10 symptoms such as tiredness,
shortness of breath, pain, and nausea.

- The FACIT-F questionnaire about how well you are able to perform the normal activities
of daily living, your quality of life, and how tired you are.

- The HADS questionnaire about your mood.

- The Pittsburgh Sleep Quality Index about your sleep quality, how long you sleep, and
any difficulties you are having when you are trying to sleep.

It should take about 25 minutes to complete all of the questionnaires.

Length of Study:

You will be on study for 28 days.

This is an investigational study. The use of light therapy in patients with difficulty
sleeping is investigational. It is currently being used for research purposes only.

Up to 152 patients will take part in this study. All will be enrolled at M. D. Anderson.