Clinical trial NCT05108233: Evaluation of Sleep Quality in Head and Neck Cancer Patients Throughout Treatment Course
Official title: Evaluation of Sleep Quality in Head and Neck Cancer Patients Throughout Treatment Course
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Head and Neck Neoplasm
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with head and neck cancer

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.

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

Primary outcomes:
measure: Time in bed
timeFrame: Up to study completion; approximately 12 months
measure: Sleep latency
timeFrame: Up to study completion; approximately 12 months
measure: Number of nighttime awakening
timeFrame: Up to study completion; approximately 12 months
measure: Sleep maintenance latency
timeFrame: Up to study completion; approximately 12 months
measure: Per-patient average score on Richards-Campbell Sleep Questionnaire
timeFrame: Up to study completion; approximately 12 months
measure: Sleep hygiene
timeFrame: Up to study completion; approximately 12 months
measure: Barriers to sleep quality
timeFrame: Up to study completion; approximately 12 months
measure: Per-patient sum of scores on Epworth Sleepiness Scale
timeFrame: Up to study completion; approximately 12 months
measure: Per-patient sum of positive responses on STOP-BANG
timeFrame: Up to study completion; approximately 12 months
measure: Per-patient sum of scores on Patient Health Questionnaire-2
timeFrame: Up to study completion; approximately 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References: