Enhanced Care Coordination for Head and Neck Cancer Survivors

NCT ID: NCT04813172

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-08
• Study Completion Date: 2024-07-31

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Head and neck cancer patients

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

Group Type: EXPERIMENTAL

Symptom Assessment

Intervention Type: 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.

Interventions

Symptom Assessment

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Marci Nilsen

Assistant Professor Acute & Tertiary Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eye and Ear Institute

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY19120089

Identifier Type: -

Identifier Source: org_study_id