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| ID | Type | Description | Link |
|---|---|---|---|
| JT 16663 | Other Identifier | JeffTrial Number |
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PI agreed to close study as prompted by PRMC inquiry
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey Administration | Other | Complete survey |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Sleep latency | How long it takes to sleep, measured in minutes. | Up to study completion; approximately 12 months |
| Number of nighttime awakening | Up to study completion; approximately 12 months | |
| Sleep maintenance latency | How long it takes to fall back to sleep, measured in minutes. | Up to study completion; approximately 12 months |
| Per-patient average score on Richards-Campbell Sleep Questionnaire | Up to study completion; approximately 12 months | |
| Sleep hygiene | Up to study completion; approximately 12 months | |
| Barriers to sleep quality | Up to study completion; approximately 12 months | |
| Per-patient sum of scores on Epworth Sleepiness Scale | Up to study completion; approximately 12 months | |
| Per-patient sum of positive responses on STOP-BANG | Up to study completion; approximately 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Non-English speaking
Pre-existing sleep disorder defined below:
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Patients diagnosed with head and neck cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Per-patient sum of scores on Patient Health Questionnaire-2 | Up to study completion; approximately 12 months |