Observational Study of Swallowing Exercises in Head and Neck Cancer
This observational study is looking at how well people with head and neck cancer that has spread (metastatic) stick to swallowing exercises. Researchers will use blood tests to look at cytokines (proteins related to the immune system) to see if they affect side effects or future disease risk. Questionnaires will help understand why people do or don't follow these exercises after radiation. The study aims to understand if your perceptions about your illness, your social support, and how you cope affect how well you do these exercises. You may be eligible if you are receiving radiation for certain head and neck cancers, including HPV-related oropharyngeal cancer, and are at least 18 years old. The study is currently unclear on its recruitment status.
- Study design
- This is an observational study with a planned enrollment of 471 participants. It is not a treatment trial, but rather observes participants over time.
- What's involved
- You would provide blood samples before and 6 months after radiation therapy. You would also complete questionnaires at home, in clinic, or online before radiation and within 14 days of blood sample collection.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed periodically for up to 2 years after the study's completion.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer
At a glance
Conditions
NCT03010150
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
M D Anderson Cancer Center
Houston, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Eileen H Shinn · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Inclusion
Exclusion
What this trial measures
- Adherence to swallowing exercisesUp to 6 months
The primary analytic approach is to use linear mixed models to determine whether illness perceptions significantly predict adherence 6 months. The study will estimate and test the illness perception subscale scores' relationship to adherence using a linear mixed model. In the model, the dependent variable is the patient's self-reported adherence score and independent variables include illness perception, follow-up assessment time point and other covariates such as demographic and medical variables, depression, pain, fatigue, emotional coping, objective coping, appraisal of coping, stress, and lack of social well-being.
- Illness perceptionsUp to 6 months
The study's statistical tool is mediation analysis: the independent variables are the sickness behaviors (depression, fatigue, pain); the mediators are the cytokine levels, and the outcome variable is illness perception. The study will test the mediator effects based on the product of coefficients method, rather than the classical Baron \& Kenny causal steps tests, since the former approach has better statistical power. The study will conduct both single-mediator analysis for each of the mediators, and multiple-mediator analysis with all mediators in the mediating process
- Effect of social support on copingUp to 6 months
The moderating effect of social support on coping and appraisal of coping is the statistical equivalent of testing the two-way interaction between these variables and the social support variable. Multivariate linear regression will be used, in which the dependent variable is appraisal of coping at 6 months follow-up, and independent variables include the emotion-focused coping and action-focused sub scales, social support, and their two-way interactions. In the regression, the study will control for baseline variables. In addition, we will also apply the linear mixed model to investigate the moderating effect of these variables longitudinally. The mixed model naturally accounts for the correlation of repeated measures at baseline and 6 months follow-up.