Clinical trial NCT00761397: Adherence to Swallowing Exercises in Head and Neck Cancer
Official title: Adherence to Swallowing Exercises in Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Cancer
Keywords: Oropharyngeal cancer
Dysphagic
Swallowing exercises
Swallowing rehabilitative regimens
PREPARE
Patients' Radiation Expectations
Prevention, Adherence, Rehabilitative Exercises
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2008-09-29
Enrollment: 485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with head and neck cancer who previously had radiation treatment

Brief summary: The goal of this research study is to help patients complete the swallowing and dental care exercises they are supposed to perform during radiation treatment.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Categorized Adherence Score (e.g., not adherence at all, somewhat adherent, and adherent to all exercises)
timeFrame: Day 1, 10 Weeks, and at 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Eileen H. Shinn, PHD, MS, BA
role: PRINCIPAL_INVESTIGATOR
References: