Spots Global Cancer Trial Database for Sleep and Circadian Rhythm Study in Head and Neck Cancer Patients

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Trial Identification

Brief Title: Sleep and Circadian Rhythm Study in Head and Neck Cancer Patients

Official Title: Sleep and Circadian Rhythm Study in Head and Neck Cancer Patients

Study ID: NCT05099952

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

Biospecimen Collection

Counseling

Educational Intervention

Electronic Health Record Review

Medical Device Usage and Evaluation

Questionnaire Administration

Study Description

Brief Summary: 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.

Detailed Description: 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.