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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DE019141-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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The goal of this research study is to look for factors that influence whether or not head and neck cancer patients follow the swallowing exercises that they are asked to perform while receiving radiation treatment.
Head and neck cancer patients who receive radiation are at risk for permanent swallowing disorders. Because of these potential problems, swallowing exercises are an important part of recovery. Researchers want to learn what factors affect how well patients follow the swallowing schedule they are given, and what can be done to make it consistent.
If you agree to take part in this study, you will have the following procedures performed.
Videotaped Swallowing Exercise:
Researchers will ask you to perform 3 swallowing exercises while being recorded by a video camera. The length of the taping session will be 3 minutes. Afterward, you will fill out 3 questionnaires. The questionnaires will take about 10 minutes to complete.
Length of Study:
You will be asked to come in 1 time for this study.
For the next 2 years, information may be collected from your medical record. This information will include the cancer stage, if the disease has gotten worse, any treatment you receive, and any side effects you experience. This information will help researchers learn how certain treatments affect patients and their risk for future disease.
This is an investigational study.
Up to 225 patient will take part in this study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1(High Accountability-Human Monitoring) | Participants randomly assigned to receive one of three sets of instructions before starting. Instructions for three swallowing exercises as well as an introductory script explaining the purpose of the exercises will be videotaped and shown to participants. Participants perform 3 swallowing exercises while researcher leaves the room. At the end of the testing period, researcher will come back into the room and record the number on participant's tracking device. Participant to tell whether they did as many repetitions as possible and if not, why they were not able to do as many as possible. This portion of the experiment will be videotaped. Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before procedure as well as a brief 3-page post-session questionnaire. |
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| Group 2(Low Accountability-Human Monitoring) | Participants randomly assigned to receive one of three sets of instructions before starting. Instructions for three swallowing exercises as well as an introductory script explaining the purpose of the exercises will be videotaped and shown to participants. Participants perform 3 swallowing exercises while researcher leaves the room. At the end of the testing period, researcher will come back into the room and record the number on participant's tracking device. Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before procedure as well as a brief 3-page post-session questionnaire. |
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| Group 3(Low Accountability-Technological Monitoring) | Participants randomly assigned to receive one of three sets of instructions before starting. Instructions for three swallowing exercises as well as an introductory script explaining the purpose of the exercises will be videotaped and shown to participants. Participants perform 3 swallowing exercises while researcher leaves the room. At the end of the testing period, researcher will come back into the room and record the number on participant's tracking device. The videocamera will tape participant's session so evaluation can be made as to exercise accuracy. Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before procedure as well as a brief 3-page post-session questionnaire. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Swallowing Exercises | Other | Participants perform 3 swallowing exercises. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Swallowing Exercises | Purpose of experiment is to determine whether an accountability manipulation and whether human vs technological monitoring result in higher patient adherence. Main outcome measure is perseverance of effort which will be number of repetitions within one minute interval for each exercise. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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Head and neck cancer patients receiving radiation therapy at MDACC clinics.
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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 |
| D009303 | Nasopharyngeal Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D007012 | Hypopharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Symptom Inventory | Behavioral | Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before swallowing exercise procedure. |
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| Questionnaires | Behavioral | Participants fill out 3 questionnaires after swallowing exercises. The questionnaires will take about 10 minutes to complete. |
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| D009302 |
| Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |