Enhanced Care Coordination for Head and Neck Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of a multidimensional symptom management intervention on decreasing symptom burden and thus reducing hospital utilization in patients undergoing radiation with or without chemotherapy for head and neck cancer.

Detailed Description
-----------------
The purpose of this study is to evaluate the effect of a multidimensional symptom assessment intervention on identifying symptoms and alerting care team of changes, and thus reducing hospital utilization, in patients undergoing radiation with or without chemotherapy for head and neck cancer. This is a pilot study. This project is being conducted to 1) examine the symptomatology of head and neck cancer patients undergoing treatment that includes radiation, 2) determine the hospital admission rates of this patient population before, during and post treatment, 3) compare the admission rates of this patient population to historical controls and 4) to examine overall patient compliance.

Official Title
-----------------
The Implementation of Enhanced Care Coordination in Order to Decrease Hospital Utilization for Head & Neck Survivors Undergoing Radiation

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

Intervention / Treatment
-----------------
* Behavioral: Symptom Assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and older Diagnosed with primary, squamous cell carcinoma of the paranasal sinuses, nasal cavity, oral cavity, tongue, salivary glands, larynx, and pharynx (including the nasopharynx, oropharynx, and hypopharynx) Will include squamous cell carcinoma found in lymph nodes as a result of unknown primary location. Prior to the initiation of radiation treatment for qualifying diagnosis Treatment occurring at Hillman Cancer Center Exclusion Criteria: Prior radiation treatment of squamous cell carcinoma of the locations listed in inclusion criteria.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Head and neck cancer patients<br>Patients from the Eye and Ear Institute Survivorship Clinic who are diagnosed with head and neck cancer. | Behavioral: Symptom Assessment<br>* Examine the symptomatology of head and neck cancer patients undergoing treatment that includes radiation by completing the M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN), the Brief Pain Index (BPI)and the Functional Assessment of Cancer Therapy for Head and Neck Cancer (FACT-H&N). They will also be asked to complete the Hearing Handicap Inventory for Adults - Screening (HHIA-S) and the Tinnitus Handicap Inventory - Screening (THI-S) as well as the Flourishing Measure. Each patient enrolled will be followed by a nurse and speech-language pathologist, twice a week, throughout their treatment (from start until 3-month post completion) All assessments are collected on a secure Ipad through REDcap database. If any significant changes occur, within 2 points from their last assessment, the nurse will notify the oncology physician and provide plan of care to avoid emergency room or hospital visit.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency Room Visits | The total number number of emergency room visits from start of radiation therapy until 90 days after treatment completion. | Start of treatment to 3 month post treatment completion | 
| Inpatient Hospitalizations | The total number number of inpatient hospital from start of radiation therapy until 90 days after treatment completion.. The length of each stay will also be counted by the number of days. | Start of treatment to 3 month post treatment completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| M.D. Anderson Symptom Inventory for Head and Neck Cancer | The M.D. Anderson Symptom Inventory for Head and neck Cancer is to assess the severity of symptoms experienced by patients with cancer and the interference with daily living caused by these symptoms. It uses a 0-10 scale 0 (the symptom was NOT present) to 10 (the symptom was As bad as you can imagine). Higher score is worse outcome. | Start of treatment to 3 month post treatment completion | 
| Brief Pain Index (BPI) | The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning in the past 24 hours. It uses a 0-10 scale 0 (the symptom was NOT present) to 10 (the symptom was As bad as you can imagine). The higher the score is worse outcome. | Start of treatment to 3 month post treatment completion | 
| Functional Assessment of Cancer Therapy for Head and Neck Cancer | The Functional Assessment of Cancer Therapy for Head and neck Cancer assesses 5 domains Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being over the past 7 days. It uses a 5 point Likert Scale: Not at all, A little bit, Somewhat, Quite a bit, Very much to rate functioning in the 5 domains. The higher the score, the better the outcome/quality of life. | Start of treatment to 3 month post treatment completion | 
| Hearing Handicap Inventory for Adults | This self-assessment tool is designed to assess the effects of hearing loss and impairment while going through radiation treatment. It is a 10 item instrument that patients select YES, SOMETIMES or NO for each question. A total possible score ranges from minimum score of 0 to maximum score of 40. The higher the score, the more handicap they have due to hearing loss and impairment. | Start of treatment to 3 month post treatment completion | 
| Tinnitus Handicap Inventory | This self assessment tool is designed to assess the severity of tinnitus handicap as well as predicting the psychological distress associated with tinnitus. The instrument consist of three subscales comprising 4 emotional items ,4 functional items and 2 catastrophic items. It is a 10 item instrument that patients select YES, SOMETIMES or NO for each question. A total possible score ranges from minimum score of 0 to maximum score of 40. The higher the score, the more handicap they have due to tinnitus. | Start of treatment to 3 month post treatment completion | 
| Flourishing Measure | The Flourishing Scale is a brief 10-item summary measure of the respondent's self-perceived success in important areas such as relationships, self-esteem, purpose, and optimism. The scale provides a single psychological well-being score. Minimum score is 0 (not satisfied) and maximum score is 10 (extremely satisfied) A high score represents a person with many psychological resources and strengths. A low score represents a person with limited psychological resources and limitations. | Start of treatment to 3 month post treatment completion |