Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
225 participants
OBSERVATIONAL
2013-05-31
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Swallowing Exercises
Participants perform 3 swallowing exercises.
Symptom Inventory
Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before swallowing exercise procedure.
Questionnaires
Participants fill out 3 questionnaires after swallowing exercises. The questionnaires will take about 10 minutes to complete.
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.
Swallowing Exercises
Participants perform 3 swallowing exercises.
Symptom Inventory
Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before swallowing exercise procedure.
Questionnaires
Participants fill out 3 questionnaires after swallowing exercises. The questionnaires will take about 10 minutes to complete.
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.
Swallowing Exercises
Participants perform 3 swallowing exercises.
Symptom Inventory
Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before swallowing exercise procedure.
Questionnaires
Participants fill out 3 questionnaires after swallowing exercises. The questionnaires will take about 10 minutes to complete.
Interventions
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Swallowing Exercises
Participants perform 3 swallowing exercises.
Symptom Inventory
Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before swallowing exercise procedure.
Questionnaires
Participants fill out 3 questionnaires after swallowing exercises. The questionnaires will take about 10 minutes to complete.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 and read English
6. Oriented to time, person, and place
7. Have a Zubrod performance status of 0 to 2
Exclusion Criteria
2. Had treatment for previous H \& N cancer or radiation to the head and neck
3. Have a history of previous head and neck surgery (excluding biopsy and/or tonsillectomy and/or tracheotomy)
4. Have a current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g., dysphagia due to underlying neurogenic disorder)
18 Years
ALL
No
Sponsors
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National Institute of Dental and Craniofacial Research (NIDCR)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Eileen H. Shinn, PHD, MS, BA
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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2013-0195
Identifier Type: -
Identifier Source: org_study_id
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