A Comprehensive Approach to Head and Neck Cancer Prehabilitation

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Comprehensive Approach to Head and Neck Cancer Prehabilitation

Conditions
-----------------
Cancer of Head and Neck

Intervention / Treatment
-----------------
* Other: Prehabilitation Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-randomized prospective two-arm clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prospective Prehabilitation<br>Prospectively enrolling patients into a prehabilitation program for head and neck cancer. | Other: Prehabilitation Program<br>* We will assess whether prehabilitation intervention helps mitigate adverse symptoms (e.g., anxiety, depression, suicidality, distress, nutritional status, dysphagia, sarcopenia, and well-being) on a sample of head and neck cancer patients. Subjects will attend a Prepare for Surgery Heal Faster session and meet with a physical therapist, registered dietician, speech language pathologist, and masters of social work at pre-treatment, 6-8 weeks post-treatment, and 5-6 months post-treatment completion.<br>|
| No Intervention: Prospective Control<br>Prospectively enrolling patients to a control arm with no intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between treatment and control group, from baseline in the BHS-6 to after treatment. | 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). | Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up | 
| Difference between treatment and control group, from baseline in the C-SSRS to after treatment. | 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). | Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up | 
| Difference between treatment and control group, from baseline in the NCCN Distress Thermometer after treatment. | 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). | Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up | 
| Difference between treatment and control group, from baseline in the MDADI to after treatment. | 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). | Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up | 
| Difference between treatment and control group, from baseline in the FACT-H&N (Version 4) to after treatment. | 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). | Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of sarcopenia on functioning | Sarcopenia will be measured using bioimpedence spectroscopy technology (BIS), a validated noninvasive measure of volume of fluids in various parts of the body. Functional assessments (sit to stand, grip strength, and two-minute walk test) will be tested as possible predictors of sarcopenia. | Baseline; post-treatment, ranging from 2 weeks to 6 months | 
| Difference between treatment and control group on sarcopenia measures | Sarcopenia measures collected via computed tomography will be used to compare patients who completed the prehabilitation program and those who have not. | Post-treatment, ranging from 2 weeks to 6 months | 
| Change from baseline to after treatment on the BHS-6. | The Behavioral Health Screening 6 (BHS-6) is a validated self-report measure of psychological health, with higher scores indicating greater psychological distress. Change = (Post-treatment score - Baseline score). | Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up | 
| Change from baseline to after treatment on the C-SSRS. | The Columbia-Suicide Severity Rating Scale (C-SSRS) is a validated self-report measure of psychological health, with higher scores indicating greater psychological distress. Change = (Post-treatment score - Baseline score). | Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up | 
| Change from baseline to after treatment on the NCCN Distress Thermometer. | The National Comprehensive Cancer Network (NCCN) Distress Thermometer is a validated self-report measure of psychological health, with higher scores indicating greater psychological distress. Change = (Post-treatment score - Baseline score). | 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. | The 2-min walk test is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score). | 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. | The 30 seconds sit to stand is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score). | Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up | 
| Change from baseline to after treatment on the grip strength. | The grip strength is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score). | Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up | 
| Change from baseline to after treatment on the NFPE. | The Nutrition Focused Physical Exam (NFPE) is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score). | Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up | 
| Change from baseline to after treatment on the MDADI. | 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. Change = (Post-treatment score - Baseline score). | Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up | 
| Change from baseline to after treatment on the BIS. | The Bioelectic impedance spectroscopy (BIS) is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score). | 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). | The FACT-H&N (Version 4) is a validated, self-report instrument of functional assessments of overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Change = (Post-treatment score - Baseline score). | Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up |