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Completed

NCT Number: NCT04813172

Enhanced Care Coordination for Head and Neck Cancer Survivors

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye and Ear Institute

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Symptom Assessment

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  1. M.D. Anderson Symptom Inventory for Head and Neck Cancer

    Time frame: 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.

  2. Brief Pain Index (BPI)

    Time frame: 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.

  3. Functional Assessment of Cancer Therapy for Head and Neck Cancer

    Time frame: 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.

  4. Hearing Handicap Inventory for Adults

    Time frame: 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.

  5. Tinnitus Handicap Inventory

    Time frame: 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.

  6. Flourishing Measure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Acronym: ECC

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 24, 2021
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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