Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-01-01 @ 12:39 AM
Study NCT ID:
NCT05108233
Status:
WITHDRAWN
Last Update Posted:
2025-09-29
First Post:
2021-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Sleep Quality in Head and Neck Cancer Patients Throughout Treatment Course
Sponsor:
Thomas Jefferson University
Organization:
Study Overview
Official Title:
Evaluation of Sleep Quality in Head and Neck Cancer Patients Throughout Treatment Course
Status:
WITHDRAWN
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI agreed to close study as prompted by PRMC inquiry
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| JT 16663 | OTHER | JeffTrial Number | View |