Enhanced Care Coordination for Head and Neck Cancer Survivors

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Behavioral: Symptom Assessment

• Registration Number: NCT04813172
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study Start: 2020-01-08
• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-24
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Head and neck cancer patients	Symptom Assessment	Patients from the Eye and Ear Institute Survivorship Clinic who are diagnosed with head and neck cancer.

Primary Outcome Measures

Name	Time	Method
Emergency Room Visits	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	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 Outcome Measures

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

Trial Locations

Locations (1)

Eye and Ear Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States