Enhanced Care Coordination for Head and Neck Cancer Survivors (ECC)
Primary Purpose
Head and Neck Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Symptom Assessment
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria:
- Age 18 and older
- Diagnosed with primary, squamous cell carcinoma 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.
Sites / Locations
- Eye and Ear InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Head and neck cancer patients
Arm Description
Patients from the Eye and Ear Institute Survivorship Clinic who are diagnosed with head and neck cancer.
Outcomes
Primary Outcome Measures
Emergency Room Visits
The total number number of emergency room visits from start of radiation therapy until 90 days after 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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04813172
First Posted
March 1, 2021
Last Updated
January 4, 2023
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT04813172
Brief Title
Enhanced Care Coordination for Head and Neck Cancer Survivors
Acronym
ECC
Official Title
The Implementation of Enhanced Care Coordination in Order to Decrease Hospital Utilization for Head & Neck Survivors Undergoing Radiation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
December 10, 2024 (Anticipated)
Study Completion Date
December 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Head and neck cancer patients
Arm Type
Experimental
Arm Description
Patients from the Eye and Ear Institute Survivorship Clinic who are diagnosed with head and neck cancer.
Intervention Type
Behavioral
Intervention Name(s)
Symptom Assessment
Intervention Description
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 Outcome Measure Information:
Title
Emergency Room Visits
Description
The total number number of emergency room visits from start of radiation therapy until 90 days after treatment completion.
Time Frame
Start of treatment to 3 month post treatment completion
Title
Inpatient Hospitalizations
Description
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.
Time Frame
Start of treatment to 3 month post treatment completion
Secondary Outcome Measure Information:
Title
M.D. Anderson Symptom Inventory for Head and Neck Cancer
Description
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.
Time Frame
Start of treatment to 3 month post treatment completion
Title
Brief Pain Index (BPI)
Description
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.
Time Frame
Start of treatment to 3 month post treatment completion
Title
Functional Assessment of Cancer Therapy for Head and Neck Cancer
Description
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.
Time Frame
Start of treatment to 3 month post treatment completion
Title
Hearing Handicap Inventory for Adults
Description
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.
Time Frame
Start of treatment to 3 month post treatment completion
Title
Tinnitus Handicap Inventory
Description
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.
Time Frame
Start of treatment to 3 month post treatment completion
Title
Flourishing Measure
Description
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.
Time Frame
Start of treatment to 3 month post treatment completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 and older
Diagnosed with primary, squamous cell carcinoma 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marci L Nilsen, MA
Phone
412-648-3027
Email
mlf981@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tina Harrison
Phone
412-953-4850
Facility Information:
Facility Name
Eye and Ear Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marci Nilsen, Ph.D
Phone
412-443-9896
Email
mlf981@pitt.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Enhanced Care Coordination for Head and Neck Cancer Survivors
We'll reach out to this number within 24 hrs