Clinical trial NCT04813172: Enhanced Care Coordination for Head and Neck Cancer Survivors
Official title: The Implementation of Enhanced Care Coordination in Order to Decrease Hospital Utilization for Head & Neck Survivors Undergoing Radiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Emergency Room Visits
timeFrame: Start of treatment to 3 month post treatment completion
measure: Inpatient Hospitalizations
timeFrame: Start of treatment to 3 month post treatment completion
Secondary outcomes:
measure: M.D. Anderson Symptom Inventory for Head and Neck Cancer
timeFrame: Start of treatment to 3 month post treatment completion
measure: Brief Pain Index (BPI)
timeFrame: Start of treatment to 3 month post treatment completion
measure: Functional Assessment of Cancer Therapy for Head and Neck Cancer
timeFrame: Start of treatment to 3 month post treatment completion
measure: Hearing Handicap Inventory for Adults
timeFrame: Start of treatment to 3 month post treatment completion
measure: Tinnitus Handicap Inventory
timeFrame: Start of treatment to 3 month post treatment completion
measure: Flourishing Measure
timeFrame: Start of treatment to 3 month post treatment completion
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Eye and Ear Institute
state: Pennsylvania
Study officials:
References: