Sleep and Circadian Rhythm Study in Head and Neck Cancer Patients
NCT ID: NCT05099952
Last Updated: 2022-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-12-15
2026-12-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I - BBT-CI
Patients participate in BBT-CI over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks.
Educational Intervention
Participate in BBT-CI sessions
Questionnaire Administration
Ancillary studies
Arm II- therapist
Patients meet with therapist over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks.
Counseling
Meet with therapist
Questionnaire Administration
Ancillary studies
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.
Biospecimen Collection
Undergo collection of cheek cell and blood samples
Electronic Health Record Review
Medical records are reviewed
Medical Device Usage and Evaluation
Wear actigraphy watch
Questionnaire Administration
Ancillary studies
Interventions
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Biospecimen Collection
Undergo collection of cheek cell and blood samples
Counseling
Meet with therapist
Educational Intervention
Participate in BBT-CI sessions
Electronic Health Record Review
Medical records are reviewed
Medical Device Usage and Evaluation
Wear actigraphy watch
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \>= 18 years of age
* Able to read, comprehend and speak the English language
* Willing to wear a wristwatch (actiwatch) and complete the sleep log to monitor sleep and activity for three weeks (Week 1, 3, and 6) during CRT
* Willing to wear the ApneaLink Air at-home sleep monitor for one night at baseline (pre-CRT)
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
* Willing to provide biospecimen samples (saliva, cheek cells, and blood) twice during CRT (week 1 and week 4) and optional for week 6
* ADDITIONAL INTERVENTIONAL STUDY CRITERIA
* Insomnia Severity Index (ISI) total score \>= 7
* Willing to complete a course of Brief Behavioral Therapy for Insomnia (BBT-CI) during the treatment weeks
* Patients who developed severe oral mucositis with World Health Organization Scale III or above with ulcers on the cheeks
* ADDITIONAL INTERVENTION STUDY (BBT-CI): Currently receiving treatment for insomnia or other sleep disorders
* ADDITIONAL INTERVENTION STUDY (BBT-CI): History of severe mental illness
* ADDITIONAL INTERVENTION STUDY (BBT-CI): Attending behavioral intervention programs for smoking cessation or other substance use disorders
* ADDITIONAL INTERVENTION STUDY (BBT-CI): Shift workers or persons with a known sleep disorder affecting regular sleep phase initiation (e.g. sleep onset outside the 9 pm- 12 am hours)
* Unwilling or unable to follow protocol requirements
* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for study participation
* Cognitively impaired adults/adults with impaired decision-making capacity, individuals who are not yet adults (infants, children, and teenagers), pregnant women, and prisoners are all excluded from this study
18 Years
ALL
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Fangyi Gu
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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NCI-2021-09748
Identifier Type: REGISTRY
Identifier Source: secondary_id
I 864421
Identifier Type: OTHER
Identifier Source: secondary_id
I 864421
Identifier Type: -
Identifier Source: org_study_id
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