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

Recruiting

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Observational (survey)	Survey Administration	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method

Locations (1): Thomas Jefferson University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States