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Brief Title: Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer
Official Title: Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer
Study ID: NCT03010150
Brief Summary: This trial uses blood tests and questionnaires to study how well participants with head and neck cancer that has spread to other places in the body adhere to swallowing exercises to prevent future disease. Using blood tests to study cytokines (proteins related to the immune system) may help doctors learn if certain levels of cytokines affect whether or not side effects occur and if they put participants at risk for future disease. Questionnaires may help doctors learn about the reasons head and neck cancer participants may or may not follow the swallowing exercises that they are asked to perform after receiving radiation treatments.
Detailed Description: PRIMARY OBJECTIVES: I. To determine whether illness perceptions significantly predict adherence to swallowing exercises at 6 months after the end of radiation. II. To determine whether sickness behaviors (depression, fatigue, pain)'s effect on illness perceptions are mediated by pro-inflammatory cytokines. III. To determine whether social support moderates the impact of coping on appraisal of coping. SECONDARY OBJECTIVES: I. As a secondary aim, to determine the feasibility and utility of cardiac impedance pre-ejection period measurement as a corollary measure for depression and distress. II. As a secondary aim, to identify potential genetic markers for swallowing dysfunction which has developed by the 6-month follow-up. OUTLINE: Participants provide blood samples prior to and at the 6-month visit after receiving radiation therapy. Participants also complete questionnaires either at home, in clinic, or via internet over 30 minutes prior to receiving radiation therapy and within 14 days of blood sample collection. After completion of study, participants are followed up periodically for up to 2 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
M D Anderson Cancer Center, Houston, Texas, United States
Name: Eileen H Shinn
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR