Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 471
- 试验地点
- 1
- 主要终点
- Illness perceptions
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Are stage I-IVb for hypopharyngeal
- •Are stage I-IVb for nasopharyngeal cancer
- •Have stage I-III unknown primary cancer with cervical
排除标准
- •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)
研究组 & 干预措施
Observational (blood tests, questionnaires)
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.
干预措施: Biospecimen Collection (Procedure)
Observational (blood tests, questionnaires)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Illness perceptions
时间窗: Up 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 coping
时间窗: Up 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.
Adherence to swallowing exercises
时间窗: Up 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.
次要结局
未报告次要终点