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

• Sponsor: Thomas Jefferson University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05108233
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 12.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Head and Neck Neoplasm	Other: Survey Administration

Detailed Description

PRIMARY OBJECTIVES:

1. To describe the five (5) components of sleep quality in head and neck patients under different stages of post-op treatment and different environment.

2. 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:

1. 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.

2. 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.

3. To compare the inpatient versus the outpatient responses on sleep hygiene at different time points of measurement.

EXPLORATORY OBJECTIVE:

1. 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Sleep Quality in Head and Neck Cancer Patients Throughout Treatment Course
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Survey Administration; Complete survey

Outcome Measures

Primary Outcome Measures

1. 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

2. Sleep latency [Up to study completion; approximately 12 months]

   How long it takes to sleep, measured in minutes.

3. Number of nighttime awakening [Up to study completion; approximately 12 months]

4. Sleep maintenance latency [Up to study completion; approximately 12 months]

   How long it takes to fall back to sleep, measured in minutes.

5. Per-patient average score on Richards-Campbell Sleep Questionnaire [Up to study completion; approximately 12 months]

6. Sleep hygiene [Up to study completion; approximately 12 months]

7. Barriers to sleep quality [Up to study completion; approximately 12 months]

8. Per-patient sum of scores on Epworth Sleepiness Scale [Up to study completion; approximately 12 months]

9. Per-patient sum of positive responses on STOP-BANG [Up to study completion; approximately 12 months]

10. Per-patient sum of scores on Patient Health Questionnaire-2 [Up to study completion; approximately 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Thomas Jefferson University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT05108233
• Other Study ID Numbers: 21D.668
• First Posted: Nov 4, 2021
• Last Update Posted: Apr 8, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Head and Neck Neoplasms

Study Results

No Results Posted as of Apr 8, 2022