Adherence to Swallowing Exercises in Head and Neck Cancer

If you agree to take part in this study, you will be taught ways to cope with the side
effects of radiation as a way to help you do your swallowing exercises during radiation
treatment. To find out if the swallowing exercises are being performed, researchers will
compare 2 groups of participants.

Study Groups:

You will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups, the Study
Program Group or the Usual Care Group. You will have an equal chance of being in either
group.

As a part of standard of care, a speech pathologist will teach you how to perform swallowing
exercises.

If you are assigned to the Study Program Group, you will complete the following:

- You will meet 1 time a week with study staff during radiation treatment either by phone
or in person. These meetings will last between 15 to 30 minutes. During the meetings,
you will be asked how many swallowing exercises you have completed during the last week
and about any problems you may have had completing the exercises.

- You will receive phone calls for 4 weeks after the last radiation treatment. These phone
calls will also last between 15 and 30 minutes. The study staff will ask questions about
if you have been doing your exercises and discuss tips to help you continue to do them.

- You will receive a weekly newsletter that has information about ways to cope with any
problems you may experience when completing the swallowing exercises.

If you are assigned to the Usual Care Group, you will complete the following:

- The study staff will follow up with you before and during your radiation treatments to
make sure that you are scheduled with and have attended your speech pathology
appointments. At these appointments, you will be taught how to do the swallowing
exercises and given information to help you complete the exercises.

- You will receive a detailed brochure explaining the purpose of the swallowing exercises
and a description of how to perform the exercises.

- You will be asked if you would like to participate in another study protocol.

Questionnaires:

Participants in both groups will fill out a questionnaire asking questions about whether or
not you have been completing the swallowing and dental exercises and how you have been coping
with stress. The questionnaire will also collect information about the disease and
demographic information such as age, gender, race, education level, and marital status. This
questionnaire will take about 30 minutes to complete each time. You will complete this
questionnaire on Day 1, and again 6 weeks, 6 months, 1 year, and 2 years after completing
radiation treatment. The second and third questionnaires will be mailed to you along with a
stamped envelope for you to return the questionnaires.

Interview:

You will be interviewed. The interview will ask questions about your successful strategies
for coping with radiation side effects.

If you disclose through your assessments or discussion that you are having suicidal thoughts
or could benefit from antidepressant medication, you may be referred for a consultation with
Dr. Alan Valentine, an M. D. Anderson psychiatrist participating in this research study.
Study staff will also let your treating doctor and/or regular doctor know about the referral
for consultation.

Newsletter:

You will allow the research staff to record any successful strategies for coping with
radiation side effects in a written newsletter that will be given to future participants.

Length of Study:

You will remain on study for up to 2 years.

This is an investigational study.

Up to 350 patients will take part in this study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Men and women are eligible if they a) are predispositioned to receive radiation
treatment for oropharyngeal, laryngeal, hypopharyngeal, nasopharyngeal, or an unknown
primary cancer with cervical metastases,

2. are stage II-IVB for oropharyngeal and laryngeal

3. are stage I-IVB for hypopharyngeal and nasopharyngeal

4. at least 18 years of age,

5. speak English,

6. are oriented to time, person, and place,

7. and have a Zubrod performance status of 0 to 2.

Exclusion Criteria:

1. have other cancer diagnoses, except non-melanoma skin cancer,

2. had treatment for previous H & N cancer or radiation to the head and neck, or

3. history of previous head and neck surgery (excluding biopsy, tonsillectomy,
tracheotomy or selective neck dissection),

4. history of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g.
dysphagia due to underlying neurogenic disorder)