Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05108233
Other study ID # 21D.668
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date December 1, 2025

Study information

Verified date March 2024
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 1, 2025
Est. primary completion date December 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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: - Non-English speaking - Pre-existing sleep disorder defined below: - Obstructive sleep apnea - Insomnia - Narcolepsy - Restless leg syndrome - Rapid eye movement (REM) sleep behavior disorder

Study Design


Intervention

Other:
Survey Administration
Complete survey

Locations

Country Name City State
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time in bed The time difference between time to get into bed and time to get up, measured in minutes Up to study completion; approximately 12 months
Primary Sleep latency How long it takes to sleep, measured in minutes. Up to study completion; approximately 12 months
Primary Number of nighttime awakening Up to study completion; approximately 12 months
Primary Sleep maintenance latency How long it takes to fall back to sleep, measured in minutes. Up to study completion; approximately 12 months
Primary Per-patient average score on Richards-Campbell Sleep Questionnaire Up to study completion; approximately 12 months
Primary Sleep hygiene Up to study completion; approximately 12 months
Primary Barriers to sleep quality Up to study completion; approximately 12 months
Primary Per-patient sum of scores on Epworth Sleepiness Scale Up to study completion; approximately 12 months
Primary Per-patient sum of positive responses on STOP-BANG Up to study completion; approximately 12 months
Primary Per-patient sum of scores on Patient Health Questionnaire-2 Up to study completion; approximately 12 months
See also
  Status Clinical Trial Phase
Completed NCT03175289 - Expiratory Muscle Strength Training in Improving Bulbar Function and Quality of Life in Patients With Head and Neck Cancer N/A
Completed NCT01896778 - Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer N/A
Completed NCT02960308 - Whole-Neck Computed Tomography Perfusion Scan in Imaging Patients With Head and Neck Tumors
Active, not recruiting NCT05126797 - 3D Printed Oral Stents for Patients With Head and Neck Cancer Receiving Radiation Therapy N/A
Active, not recruiting NCT04607590 - Yoga Program for Improving the Quality of Life in Couples Coping With Cancer
Recruiting NCT01365169 - Association Between Health Care Provider (HCP)-Assessed ECOG Performance Status (PS) and Overall Survival, and Objectively Measure of Physical Activity (PA) Levels in Advance-cancer Patients" N/A
Active, not recruiting NCT05036330 - ProvoxLife Adoption Trends for Heat-Moisture Exchanger
Completed NCT03032250 - Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer N/A
Completed NCT04456140 - Pro-Active Genetic Testing in Patients With Solid Tumors, Inherit Study Phase 1
Active, not recruiting NCT01366144 - Veliparib, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery and Liver or Kidney Dysfunction Phase 1
Completed NCT02480114 - Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy Phase 3
Recruiting NCT05457478 - The Use of "Smart" Body-Weight Scales for Weight and Nutritional Monitoring in Patients With Head and Neck Cancer Undergoing Radiation Therapy N/A
Recruiting NCT04963972 - Digital and Behavioral Tele-Health Tapering Program for Lowering Dependence on Opioids in Patients Undergoing Surgery N/A
Completed NCT05793957 - Use of Virtual Reality Goggles During Chemotherapy Infusion to Reduce Anxiety-Related Symptoms N/A