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Clinical Trials/NCT04813172
NCT04813172
Completed
N/A

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

University of Pittsburgh1 site in 1 country250 target enrollmentJanuary 8, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
University of Pittsburgh
Enrollment
250
Locations
1
Primary Endpoint
Emergency Room Visits
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
January 8, 2020
End Date
July 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marci Nilsen

Assistant Professor Acute & Tertiary Care

University of Pittsburgh

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.

Outcomes

Primary Outcomes

Emergency Room Visits

Time Frame: Start of treatment to 3 month post treatment completion

The total number number of emergency room visits from start of radiation therapy until 90 days after treatment completion.

Inpatient Hospitalizations

Time Frame: Start of treatment to 3 month post treatment completion

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.

Secondary Outcomes

  • Tinnitus Handicap Inventory(Start of treatment to 3 month post treatment completion)
  • Brief Pain Index (BPI)(Start of treatment to 3 month post treatment completion)
  • Hearing Handicap Inventory for Adults(Start of treatment to 3 month post treatment completion)
  • Functional Assessment of Cancer Therapy for Head and Neck Cancer(Start of treatment to 3 month post treatment completion)
  • M.D. Anderson Symptom Inventory for Head and Neck Cancer(Start of treatment to 3 month post treatment completion)
  • Flourishing Measure(Start of treatment to 3 month post treatment completion)

Study Sites (1)

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