Head and Neck CancerECCNCT04813172
Enhanced Care Coordination for Head and Neck Cancer Survivors
A study testing Symptom Assessment in people with Head and Neck Cancer, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Symptom Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2020to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior radiation treatment of squamous cell carcinoma of the locations listed in inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eye and Ear Institute
Pittsburgh, Pennsylvania, 15213
About this study
Official title: The Implementation of Enhanced Care Coordination in Order to Decrease Hospital Utilization for Head & Neck Survivors Undergoing Radiation
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Symptom Assessment
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom AssessmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Head and neck cancer patients | Experimental | Patients from the Eye and Ear Institute Survivorship Clinic who are diagnosed with head and neck cancer. Receives: Behavioral: Symptom Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Room Visits
The total number number of emergency room visits from start of radiation therapy until 90 days after treatment completion.
Measured: Start of treatment to 3 month post 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.
Measured: Start of treatment to 3 month post treatment completion
Secondary outcomes (6)
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.
Measured: Start of treatment to 3 month post treatment completion
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.
Measured: Start of treatment to 3 month post treatment completion
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.
Measured: Start of treatment to 3 month post treatment completion
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.
Measured: Start of treatment to 3 month post treatment completion
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.
Measured: Start of treatment to 3 month post treatment completion
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.
Measured: Start of treatment to 3 month post treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start8 Jan 2020
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marci Nilsen, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813172
- Sponsor's protocol ID
- STUDY19120089
- Acronym
- ECC
- Status last verified
- Jan 2025
- First submitted
- 1 Mar 2021
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implementation of Enhanced Care Coordination in Order to Decrease Hospital Utilization for Head & Neck Survivors Undergoing Radiation
- ClinicalTrials.gov ID
- NCT04813172
- Acronym / sponsor ID
- ECC / STUDY19120089
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and neck cancer patients | Experimental | Behavioral: Symptom AssessmentPatients from the Eye and Ear Institute Survivorship Clinic who are diagnosed with head and neck cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Prior radiation treatment of squamous cell carcinoma of the locations listed in inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptom AssessmentExamine 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. | Behavioural | Head and neck cancer patients |
Primary outcome
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.
6 secondary outcomes
M.D. Anderson Symptom Inventory for Head and Neck Cancer
Time frame: Start of treatment to 3 month post treatment completion
Brief Pain Index (BPI)
Time frame: Start of treatment to 3 month post treatment completion
Functional Assessment of Cancer Therapy for Head and Neck Cancer
Time frame: Start of treatment to 3 month post treatment completion
Hearing Handicap Inventory for Adults
Time frame: Start of treatment to 3 month post treatment completion
Tinnitus Handicap Inventory
Time frame: Start of treatment to 3 month post treatment completion
Flourishing Measure
Time frame: Start of treatment to 3 month post treatment completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symptom Assessment in people with Head and Neck Cancer, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency Room Visits (time frame: Start of treatment to 3 month post treatment completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.