Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT03010150|
Recruitment Status : Recruiting
First Posted : January 4, 2017
Last Update Posted : February 16, 2018
|Condition or disease||Intervention/treatment|
|Malignant Neoplasms of Lip Oral Cavity and Pharynx Head and Neck Cancer||Behavioral: Questionnaire Procedure: Blood Draw|
If participant agrees to take part in this study, participant will complete the below study tests at participant's first study visit and about 6 months after participant's radiation treatment.
Participant will complete a questionnaire (either in the clinic or at home) about how well participant is following the swallowing exercises and how participant has been coping with stress. The questionnaire will also collect information about the disease and personal information about participant, such as participant's age, sex, race, education level, and marital status. This questionnaire should take about 30 minutes to complete. On the Day 1 visit, participant will not complete the part of the questionnaire that asks about participant's swallowing exercises.
If participant prefers to complete the questionnaire online, a separate email will be sent to participant's email address. The email will contain a link to a secure online questionnaire protected by MD Anderson.
Cytokine Blood Tests:
Blood (about 1-2 teaspoons each time) will be drawn to measure the level of cytokines in participant's blood 2 times. These blood samples will be drawn at the same time as other routine blood draws so participant will not have extra needle sticks.
Researchers want to learn 1) if cytokine levels are related to changes in the types of side effects participant may have, such as fatigue and nausea, 2) which patients are at risk for developing permanent swallowing dysfunction after radiation treatment, and 3) which patients are at risk for developing recurrence after treatment.
Researchers will also study participant's genetic code to try to predict cytokine levels or what side effects participant may have. This means researchers may need to store parts of participant's blood for a long time, maybe with no time limit, to complete the genetic testing. However, these samples will only be used for research testing as described in this consent form.
Length of Study:
Participant's active participation in this study will be over after participant completes the 6 month questionnaire and blood draw.
Information from participant's medical record (such as information about participant's disease history, if the disease has gotten worse, any treatment participant receives, and any side effects participant has) will continue to be collected for up to 2 years after participant completes radiation therapy.
This is an investigational study.
Up to 230 participants will be enrolled in this study. All will take part at MD Anderson.
|Study Type :||Observational|
|Estimated Enrollment :||230 participants|
|Official Title:||Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Head and Neck Cancer Group Adherence to Swallowing Exercises
Questionnaire completed at baseline and 6 months after radiation therapy. Blood drawn to measure the level of cytokines in blood at baseline and 6 months after radiation therapy.
Participants complete an assessment questionnaire at baseline.
Six months after radiation therapy, participant completes another assessment questionnaire that will also ask about adherence to swallowing exercises.
Other Name: Survey
Procedure: Blood Draw
Blood (about 1-2 teaspoons each time) drawn to measure the level of cytokines in participant's blood at baseline, and 6 months after radiation therapy.
- Adherence to Swallowing Exercises Due to Illness Perceptions [ Time Frame: 6 months ]Participant's illness perception subscale scores', and relationship to adherence to swallowing exercises estimated using a linear mixed model.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010150
|Contact: Eileen H. Shinn, PHD, MS, BA||713-745-0870|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Eileen H. Shinn, PHD, MS, BA||M.D. Anderson Cancer Center|