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Testing Accountability in Patient Adherence
Conditions
Head And Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
Head And Neck Cancer, Nasopharyngeal cancer, Oropharyngeal cancer, Hypopharyngeal cancer, Laryngeal cancer, Primary cancer with cervical metastases, Swallowing exercises, Videotape, Videocamera, M.D. Anderson Symptom Inventory, Questionnaires, Surveys
Study Type
Observational
Study Phase
Phase 1/Phase 2
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: Swallowing Exercises
Type: Other
Name: Symptom Inventory
Type: Behavioral
Name: Questionnaires
Type: Behavioral
Overall Status
Recruiting
Summary
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.
Detailed Description
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
1. Are dispositioned to receive radiation with curative intent for nasopharyngeal, oropharyngeal, hypopharyngeal, laryngeal, 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 and read English
6. Oriented to time, person, and place
7. 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
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)
1. Are dispositioned to receive radiation with curative intent for nasopharyngeal, oropharyngeal, hypopharyngeal, laryngeal, 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 and read English
6. Oriented to time, person, and place
7. 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
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)
Location
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Start Date
May 2013
Sponsors
M.D. Anderson Cancer Center
Source
M.D. Anderson Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page