Clinical Trial: Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer

Brief Summary:

Head and neck cancer patients who receive radiation therapy are at risk for permanent swallowing disorders and problems with their teeth. Because of these potential problems, swallowing exercises and good dental habits are an important part of recovery.

The goal of this clinical research study is to learn about the reasons head and neck cancer patients may or may not follow the swallowing exercises that they are asked to perform after receiving radiation treatments. Researchers also want to learn if certain levels of cytokines affect if participant has side effects and if it puts participant at risk for future disease. Cytokines are proteins that are related to the immune system.


Detailed Summary:

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.

Questionnaire:

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 wi
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: January 3, 2017
Date Started: December 2016
Date Completion:
Last Updated: January 3, 2017
Last Verified: January 2017