A Comprehensive Approach to Head and Neck Cancer Prehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Difference between treatment and control group, from baseline in the NCCN Distress Thermometer after treatment.
研究概览
简要总结
Head and neck cancer accounts for 3% of malignancies in the United States. However, the diagnosis and treatment for head and neck cancer is considered to be debilitating. Not because of its morbidity, but due to the extremely rigorous treatment course which has a profound impact on patients physical, social, and emotional functioning. Disfigurement and sensorimotor deficits further compound this impact. Head and neck cancer patients contend with treatments that can significantly affect their quality of life. Treatment regularly results in decreased functional capacity and decreased quality of life. Physical impairments are manifested through, but not limited to, disfigurement, deconditioning, communication issues, "swallowing, speech, breathing, and cancer-related fatigue". Premorbid factors such as preexisting anxiety and depression, chemical dependency, financial barriers, and lack of social support system are unique obstacles to the head and neck cancer population impacting treatment and outcomes. Due to these factors, patients experience higher rates of anxiety and depression, psychological distress, and fear of cancer recurrence. In fact, "compared with other survivors of cancer, head and neck cancer survivors are almost 2 times more likely to die from suicide". In view of the aforementioned research, Roger Maris Cancer Center's head and neck cancer will implement a prehabilitation program that evaluates each patient using standardized screening tools and provide personalized education and interventions. This project evaluates a more comprehensive and proactive multidisciplinary approach to improve treatment and outcomes in head and neck cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Equal to or greater than 18 years of age
- •Diagnosis of head and neck cancer
- •Actively pursuing cancer treatment with a curative intent
- •Willing and able to provide written consent
排除标准
- •Patients with cardiac arrhythmia with implanted pacemaker
- •Patients with other implanted electronic equipment/device
- •Patients undergoing external defibrillation
- •Pregnant women (per BIS instructions for use, pregnant women should not participate)
- •Patient weight exceeding 375 lbs.
- •Patient has a metal allergy
研究组 & 干预措施
Prospective Prehabilitation
Prospectively enrolling patients into a prehabilitation program for head and neck cancer.
干预措施: Prehabilitation Program (Other)
Prospective Control
Prospectively enrolling patients to a control arm with no intervention.
结局指标
主要结局
Difference between treatment and control group, from baseline in the NCCN Distress Thermometer after treatment.
时间窗: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
The National Comprehensive Cancer Network (NCCN) Distress Thermometer is a validated, self-report instrument assessing psychological health. Higher scores indicate greater psychological distress. Difference = (Treatment score - Control score).
Difference between treatment and control group, from baseline in the MDADI to after treatment.
时间窗: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
The MD Anderson Dysphagia Inventory (MDADI) is a validated, self-report instrument of functional assessments of dysphasia and overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Difference = (Treatment score - Control score).
Difference between treatment and control group, from baseline in the FACT-H&N (Version 4) to after treatment.
时间窗: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
The FACT-H\&N (Version 4) is a validated, self-report instrument of functional assessments of dysphasia and overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Difference = (Treatment score - Control score).
Difference between treatment and control group, from baseline in the BHS-6 to after treatment.
时间窗: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
The Behavioral Health Screening 6 (BHS-6) is a validated, self-report instrument assessing psychological health. Higher scores indicate greater psychological distress. Difference = (Treatment score - Control score).
Difference between treatment and control group, from baseline in the C-SSRS to after treatment.
时间窗: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a validated, self-report instrument assessing suicidality. Higher scores indicate greater suicidality. Difference = (Treatment score - Control score).
次要结局
- Impact of sarcopenia on functioning(Baseline; post-treatment, ranging from 2 weeks to 6 months)
- Change from baseline to after treatment on the NCCN Distress Thermometer.(Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up)
- Change from baseline to after treatment on the NFPE.(Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up)
- Change from baseline to after treatment on the C-SSRS.(Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up)
- Difference between treatment and control group on sarcopenia measures(Post-treatment, ranging from 2 weeks to 6 months)
- Change from baseline to after treatment on the BIS.(Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up)
- Change from baseline to after treatment on the BHS-6.(Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up)
- Change from baseline to after treatment on the 2-min walk test.(Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up)
- Change from baseline to after treatment on the grip strength.(Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up)
- Change from baseline to after treatment on the MDADI.(Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up)
- Change from baseline to after treatment on the 30 seconds sit to stand.(Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up)
- Change from baseline to after treatment on the FACT-H&N (Version 4).(Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up)