Ignite Creation Date:
2025-12-18 @ 6:37 AM
Ignite Modification Date:
2025-12-18 @ 6:37 AM
Study NCT ID:
NCT00761397
Status:
None
Last Update Posted:
2020-01-13 00:00:00
First Post:
2008-09-25 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adherence to Swallowing Exercises in Head and Neck Cancer
Sponsor:
None
Organization:
Study Overview
Official Title:
Adherence to Swallowing Exercises in Head and Neck Cancer
Status:
None
Status Verified Date:
2020-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: