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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-09748 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 864421 | Other Identifier | Roswell Park Cancer Institute |
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PI left institute-no accruals
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This clinical trial studies the effect and underlying mechanisms of sleep and circadian rhythm factors on oral mucositis pain in head and neck cancer patients treated by chemoradiotherapy. Poor sleep may have a correlation to increased pain. A behavioral intervention, Brief Behavioral Therapy for Cancer related Insomnia, may improve patients' sleep and may also reduce oral mucositis pain.
PRIMARY OBJECTIVES:
I. To examine the effect and underlying mechanisms of sleep and circadian rhythm factors on oral mucositis pain in head and neck cancer patients treated by chemoradiotherapy.
Ia. To assess the impact of chemo-radiotherapy (CRT) on the onset and duration of sleep disturbance in head and neck carcinoma (HNC) patients, and identify factors that trigger or aggravate sleep disturbance.
Ib. To examine the effect of the association between sleep and CRT-induced oral mucositis (OM) pain.
SECONDARY OBJECTIVE:
I. To examine the pathways by which sleep disturbance may aggravate radiation-induced OM pain.
OUTLINE:
OBSERVATIONAL STUDY: Patients wear actigraphy watch and complete sleep log at baseline (over the weekend prior to first day of CRT), and weeks 1, 3, and 6 during treatment. Patients also undergo collection of cheek cell samples and may undergo collection of blood samples at weeks 1, 3 and 6 during treatment. Patients' medical records are also reviewed.
INTERVENTION STUDY: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in BBT-CI over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks.
ARM II: Patients meet with therapist over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks.
After completion of study, patients are followed up at 1, 3, 6, and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I - BBT-CI | Experimental | Patients participate in BBT-CI over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks. |
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| Arm II- therapist | Active Comparator | Patients meet with therapist over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks. |
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| Observational Study | Experimental | Patients wear actigraphy watch and complete sleep log at baseline (over the weekend prior to first day of CRT), and weeks 1, 3, and 6 during treatment. Patients also undergo collection of cheek cell samples and may undergo collection of blood samples at weeks 1, 3 and 6 during treatment. Patients' medical records are also reviewed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of cheek cell and blood samples |
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| Measure | Description | Time Frame |
|---|---|---|
| Development of oral mucositis (OM) | OM is assessed weekly during treatment by clinical exam and patient reported Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN). | Up to 1 year |
| Self-reported oral mucositis pain | OM pain is assessed using a visual analog scale that rates patients' overall mouth and throat soreness, on a scale of 0-10, weekly during CRT and after chemoradiotherapy (CRT) up to one year at follow up visits. | Up to 1 year |
| Insomnia Severity Index (ISI) | A brief questionnaire where the total responses are added up with higher scores indicating more acute symptoms of insomnia. | Up to 1 year |
| Sleep Efficiency | Will be measured by using a non-invasive wrist actigraphy monitor. | Up to 1 year |
| Sleep Disturbance | Sleep diaries will assess sleep and wake time | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic inflammatory markers will include IL-6, IL1b and TNF. | Up to 1 year | |
| Correlation of sleep measurement with total opioid use | Opioids are carefully prescribed as standard of care during CRT according to the severity of pain. Total opioid use, summarized by morphine milligram equivalents, will therefore also be assessed as a surrogate for overall pain severity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fangyi Gu | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| Counseling | Other | Meet with therapist |
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| Educational Intervention | Other | Participate in BBT-CI sessions |
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| Electronic Health Record Review | Other | Medical records are reviewed |
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| Medical Device Usage and Evaluation | Other | Wear actigraphy watch |
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| Questionnaire Administration | Other | Ancillary studies |
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| Up to 1 year |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002662 | Child Health Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
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