Enhanced Care Coordination for Head and Neck Cancer Survivors

NCT04813172 | Completed

• 1 other identifier: STUDY19120089
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

• Emergency Room Visits

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

  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.

  Start of treatment to 3 month post treatment completion

Secondary Outcomes (6)

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

  Start of treatment to 3 month post treatment completion

• Brief Pain Index (BPI)

  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

• Hearing Handicap Inventory for Adults

  Start of treatment to 3 month post treatment completion

• Tinnitus Handicap Inventory

  Start of treatment to 3 month post treatment completion

Study Arms (1)

Head and neck cancer patients

EXPERIMENTAL

Patients from the Eye and Ear Institute Survivorship Clinic who are diagnosed with head and neck cancer.

Behavioral: Symptom Assessment

Interventions

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.

Head and neck cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Eye and Ear Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Acute & Tertiary Care

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 24, 2021
• Study Start: January 8, 2020
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)