About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Are dispositioned to receive radiation with curative intent for nasopharyngeal, oropharyngeal, hypopharyngeal, laryngeal, or an unknown primary cancer with cervical metastases
Are stage II-IVb for non- human papillomavirus (HPV)- related oropharyngeal cancer
Have HPV- related oropharynx cancer that is T1, have nodal involvement with no distant metastasis or have HPV- related oropharynx cancer that is at least T2 with no distant metastasis
Are stage II-IVb for laryngeal cancer
Disqualifiers
Have other cancer diagnoses, except non-melanoma skin cancer
Had treatment for previous head and neck cancer or radiation to the head and neck
Have a history of previous head and neck surgery (excluding biopsy and/or tonsillectomy and/or tracheotomy)
Have a current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g., dysphagia due to underlying neurogenic disorder)
Trial population
Participants with head and neck cancer
Trial design
Cohort
Prospective
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryProvide blood samples
Questionnaire Administration
Other interventionAncillary studies
Treatment groups
Trial outcomes
Primary outcomes
Adherence to swallowing exercises
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 perceptions
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 coping
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.
Sponsors and contacts
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M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator