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Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
M D Anderson Cancer Center
Houston, Texas, United States
Start Date
December 29, 2016
Primary Completion Date
December 31, 2028
Completion Date
December 31, 2028
Last Updated
November 3, 2025
471
ESTIMATED participants
Biospecimen Collection
PROCEDURE
Questionnaire Administration
OTHER
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT05075980
NCT06636734
Data Source & Attribution
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