Evaluation of Sleep Quality in Head and Neck Cancer Patients Throughout Treatment Course

This study examines how head and neck cancer treatment affects quality of sleep over time and factors that contribute to sleep quality. Sleep plays a critical role in healing and quality of life, and recent studies investigating sleep disorders in head and neck cancer patients reveal sleep quality is a major determinant of post-treatment outcomes. Information from this study may help researchers better understand how treatment impacts sleep quality so that they can make changes that may help improve patient sleep quality.

Study Overview

• Status: Recruiting
• Conditions: Malignant Head and Neck Neoplasm
• Intervention / Treatment: Other: Survey Administration

Detailed Description

PRIMARY OBJECTIVES:

I. To describe the five (5) components of sleep quality in head and neck patients under different stages of post-op treatment and different environment.

II. To evaluate the effect of surgery, treatment and environment on the five (5) components of sleep quality in head and neck cancer patients.

SECONDARY OBJECTIVES:

I. To evaluate the association between the five (5) components of sleep quality and comorbid obstructive sleep apnea (STOP-BANG and Epworth Sleeping Scale) and depression (Patient Health Questionnaire-2 [PHQ-2]), under different stages of post-op treatment and different environment.

II. To evaluate the association between Fitbit actigraphy data (i.e. the 5th component of sleep quality) and the first 4 components of sleep quality for inpatients.

III. To compare the inpatient versus the outpatient responses on sleep hygiene at different time points of measurement.

EXPLORATORY OBJECTIVE:

I. To assess whether survey results warrant additional counseling or patient education.

OUTLINE:

COHORT 1-TP1: Patients complete surveys over 20 minutes on post-op day 3 and on day of discharge (or within 1 week).

COHORT 1-TP2: Patients complete surveys over 15 minutes at all regularly scheduled follow-up appointments (approximately 1 month, 3 months, 6 months, 12 months).

COHORT 2: Patients complete surveys over 15 minutes once.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital
      • Contact: Richard Goldman, M.D.; Phone Number: 215-955-6760; Email: richard.goldman@jefferson.edu
      • Principal Investigator: Richard Goldman, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with head and neck cancer

Description

Inclusion Criteria:

• Males and females
• Adult at least 18 years old
• Capable of giving informed consent
• Diagnosed with head and neck cancer (previously untreated, any stage)
• Treatment plan involves surgery
• Willing to comply with all study procedures and be available for the duration of the study
• English-speaking

Exclusion Criteria:

• Non-English speaking

• Pre-existing sleep disorder defined below:

  • Obstructive sleep apnea
  • Insomnia
  • Narcolepsy
  • Restless leg syndrome
  • Rapid eye movement (REM) sleep behavior disorder

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (survey); COHORT 1-TP1: Patients complete surveys over 20 minutes on post-op day 3 and on day of discharge (or within 1 week). COHORT 1-TP2: Patients complete surveys over 15 minutes at all regularly scheduled follow-up appointments (approximately 1 month, 3 months, 6 months, 12 months). COHORT 2: Patients complete surveys over 15 minutes once.	Other: Survey Administration; Complete survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in bed	The time difference between time to get into bed and time to get up, measured in minutes	Up to study completion; approximately 12 months
Sleep latency	How long it takes to sleep, measured in minutes.	Up to study completion; approximately 12 months
Number of nighttime awakening		Up to study completion; approximately 12 months
Sleep maintenance latency	How long it takes to fall back to sleep, measured in minutes.	Up to study completion; approximately 12 months
Per-patient average score on Richards-Campbell Sleep Questionnaire		Up to study completion; approximately 12 months
Sleep hygiene		Up to study completion; approximately 12 months
Barriers to sleep quality		Up to study completion; approximately 12 months
Per-patient sum of scores on Epworth Sleepiness Scale		Up to study completion; approximately 12 months
Per-patient sum of positive responses on STOP-BANG		Up to study completion; approximately 12 months
Per-patient sum of scores on Patient Health Questionnaire-2		Up to study completion; approximately 12 months

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 21D.668

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No