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

Malignant Head and Neck Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05108233
• Other study ID #: 21D.668
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Malignant Head and Neck Neoplasm

Intervention

Other:
• Survey Administration
Complete survey

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Sleep latency	How long it takes to sleep, measured in minutes.	Up to study completion; approximately 12 months
Primary	Number of nighttime awakening		Up to study completion; approximately 12 months
Primary	Sleep maintenance latency	How long it takes to fall back to sleep, measured in minutes.	Up to study completion; approximately 12 months
Primary	Per-patient average score on Richards-Campbell Sleep Questionnaire		Up to study completion; approximately 12 months
Primary	Sleep hygiene		Up to study completion; approximately 12 months
Primary	Barriers to sleep quality		Up to study completion; approximately 12 months
Primary	Per-patient sum of scores on Epworth Sleepiness Scale		Up to study completion; approximately 12 months
Primary	Per-patient sum of positive responses on STOP-BANG		Up to study completion; approximately 12 months
Primary	Per-patient sum of scores on Patient Health Questionnaire-2		Up to study completion; approximately 12 months