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

NCT ID: NCT05108233

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2025-12-01

Brief 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.

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.

Conditions

Malignant Head and Neck Neoplasm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Survey Administration

Intervention Type: OTHER

Complete survey

Interventions

Survey Administration

Complete survey

Intervention Type: OTHER

Eligibility Criteria

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

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

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

JT 16663

Identifier Type: OTHER

Identifier Source: secondary_id

21D.668

Identifier Type: -

Identifier Source: org_study_id