Enhanced Care Coordination for Head and Neck Cancer Survivors (ECC)

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Behavioral: Symptom Assessment

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Eye and Ear Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 and older
• Diagnosed with primary, head and neck cancer 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Head and neck cancer patients; Patients from the Eye and Ear Institute Survivorship Clinic who are diagnosed with head and neck cancer.

Behavioral: Symptom Assessment; 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.

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

Collaborators and Investigators

• Sponsor: University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2020
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: STUDY19120089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No