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Trials / Recruiting

RecruitingNCT03010150

Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer

Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer

Status
Recruiting
Phase
—
Study type
Observational
Enrollment
471 (estimated)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREBiospecimen CollectionProvide blood samples
OTHERQuestionnaire AdministrationAncillary studies

Timeline

Start date
2016-12-29
Primary completion
2028-12-31
Completion
2028-12-31
First posted
2017-01-04
Last updated
2026-04-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03010150. Inclusion in this directory is not an endorsement.

Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastati (NCT03010150) · Clinical Trials Directory