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

Thomas Jefferson University

Status: Withdrawn

Conditions: Malignant Head and Neck Neoplasm

Treatments: Other: Survey Administration

Study type: Observational

Funder types: Other

Identifiers

NCT05108233

JT 16663 (Other Identifier)

21D.668

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Observational (survey)

Description:

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.

Treatment:

Other: Survey Administration