Depression and Adherence in Head and Neck Cancer
Depression and Adherence in Head and Neck Cancer
Primary Objectives:

 -  Develop and pilot test an innovative intervention to determine its feasibility and
 acceptability to patients. Recruitment rate, patient satisfaction, attendance,
 questionnaire completion rates and the reliability and validity of the questionnaires
 will be assessed.

 -  Conduct preliminary analyses on the efficacy of the intervention in improving patients'
 depression. Evaluate whether depression levels in patients receiving the intervention
 decreases, and whether the decrease is greater among those who complete more sessions.

 -  Test the relationship between patients' depression levels and adherence to swallowing
 rehabilitation and to dental preventive maintenance regimens.
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.
Inclusion Criteria:

 1. Stage I-IV

 2. At least 18 years of age

 3. Speak and read English at a 7th grade level

 4. Are oriented to time, person, and place

 5. Have a Zubrod performance status of 0-3.

 6. To be eligible for the pilot depression intervention patients must score 9 or above on
 the Patient Health Questionnaire (PHQ-9). Additionally, if a patient has an elevated
 PHQ score and does not meet the cutoff but expresses a desire to be in the
 intervention in order to relieve his or her depression, then the PI will contact the
 participant to further assess eligibility for the intervention. Patients who do not
 make the cut-off will still be included in the study's statistical analyses.

 Exclusion Criteria:

 1. Do not have other cancer diagnoses, excepting non-melanoma skin cancer.