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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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.
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:
If you are assigned to the Usual Care Group, you will complete the following:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Program Group |
| ||
| Usual Care Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interview | Behavioral | 15-30 Minute Weekly meeting w/Staff to discuss swallowing exercises |
|
| Measure | Description | Time Frame |
|---|---|---|
| Categorized Adherence Score (e.g., not adherence at all, somewhat adherent, and adherent to all exercises) | Day 1, 10 Weeks, and at 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with head and neck cancer who previously had radiation treatment
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| Name | Affiliation | Role |
|---|---|---|
| Eileen H. Shinn, PHD, MS, BA | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Phone Call | Behavioral | Phone call follow ups for 4 weeks after last radiation treatment |
|
| Brochure | Other | Detailed brochure explaining the purpose of the swallowing exercises and a description of how to perform the exercises |
|
| Questionnaire | Other | Day 1 of study, 10 weeks after starting study, & 12 months after starting study |
|
| D010608 |
| Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |