Trial Information

Depression and Adherence in Head and Neck Cancer

You will be asked to fill out a questionnaire containing questions about your mood, coping
with cancer, how closely you follow your treatment schedule, your thoughts, your demographic
information (such as age and race), and your medical history. It should take between 25-35
minutes to complete the questionnaire. If you score as nondepressed on the questionnaire,
you will be contacted again every week for 6 weeks during radiation treatment, to check for
depression again. If you score as depressed during a later screening, you will then be
asked additional questions about your symptoms, coping, and social support. It should take
between 10-20 minutes to complete these additional questions.

If the answers to your questionnaire indicate that you may be depressed, you will be offered
the intervention portion of the study. Only those participants who score as depressed on
the questionnaire will be assigned to the intervention. You will then be informed of your
test results, and provided with a list of community referrals. Whoever is responsible for
your treatment, whether he or she is a M.D. Anderson physician, community referring
physician, or both, will also be informed of these test results, and a note will be added to
your medical record.

You will be asked to take part in 7 sessions with a trained doctoral-level psychologist or
advanced clinical doctoral student under the supervision of a licensed psychiatrist. The
first two sessions may be conducted in person, face to face, or may be conducted over the
telephone. The remaining five sessions will be done over the telephone. These sessions will
last between 30 and 45 minutes and will occur every week for seven weeks.

The 30-45 minute telephone sessions will use "cognitive-behavioral" techniques, a method
proven to be effective in relieving depressive symptoms. Cognitive-behavioral techniques
will teach you skills in relaxation and activity scheduling, as well as ways to recognize
and fight negative thoughts. You will also be given a journal to record and practice ways
of fighting depression. The intervention will include an educational component for your
spouse/partner or caregiver on the nature of clinical depression. The spouse/caregiver will
be given a booklet which explains facts about depressive disorders and helpful ways that
they can support you. You may also be given over-the counter samples of toothpaste and oral
products if approved by your doctor or dentist. You will also be given the use of a
mini-food-blender to help you problem solve issues of eating during the course of the study.
You will be asked to return the mini-food-blender at the end of the study.

If you participate in the intervention, upon completion, you will receive a short survey
asking about your satisfaction with the intervention. After completing the first
questionnaire, you may be contacted again to complete five follow-up questionnaires, at the
beginning of radiation treatment, as well as, six and twelve weeks and again, six and twelve
months after radiation treatment begins. The questionnaires will be similar to the first
one but will also contain questions about any additional depression care you received while
participating in the study or after the intervention. This information will include
prescription of antidepressants, formal referral to psychiatric services, referral to
support groups, and any depression care you received in addition to the intervention in this
study. You will also be asked how closely you followed the swallowing exercises, your dental
care habits, and your referrals to other sources in the community.

Researchers will also collect medical information from your medical record such as cancer
stage, if the disease has gotten worse, treatment, and side effects. This information will
allow researchers to look at how specific treatments affect patients. You may also be
involved in an interview regarding your personal experience. The study staff will
tape-record the interview after you have given your consent verbally and on the tape. In
order to protect your confidentiality, the study staff will store the digital record of the
interview on an external hard drive, and the record will be destroyed after the study is
complete.

To provide quality control for the intervention, a random sample of telephone counseling
sessions may be tape-recorded. Before tape-recording the session, the counselor will ask
for your permission to be tape-recorded, and will then tape-record your permission on the
audiotape. No identifying information will be recorded on the audiotape, and the recorded
sessions will be reviewed by project team members for research purposes only. Audiotapes
will be labeled with study identification numbers only, so none of your personal information
will be on the tape itself.

If your answers to the questionnaires or your responses during the face-to-face sessions or
telephone calls show that you are having suicidal thoughts or may need antidepressant
medication, you will be referred for a consultation with Dr. Alan Valentine, a M.D. Anderson
psychiatrist who is also participating in this research study. Researchers will also let
your treating physicians know about the referral to Dr. Valentine, if you are referred for
further treatment.

If your answers to the questionnaires or your responses during the face to face sessions or
telephone calls show that you have a problem with alcohol abuse, you will be referred for a
consultation with Dr. Kathleen Rickman, a M.D. Anderson advanced nurse practitioner who is
also participating in this research study. Researchers will also let your treating
physicians know about the referral to Dr. Rickman if you are referred for further treatment.

This is an investigational study. A total of 350 head and neck cancer patients will take
part in this study. All will be enrolled at M.D. Anderson.