Sleep and Circadian Rhythm Study in Head and Neck Cancer Patients

Roswell Park Comprehensive Cancer Center

Status: Withdrawn

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Other: Counseling; Other: Questionnaire Administration; Other: Educational Intervention; Other: Electronic Health Record Review; Procedure: Biospecimen Collection; Other: Medical Device Usage and Evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT05099952

NCI-2021-09748 (Registry Identifier)

I 864421 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with histologically confirmed head and neck squamous cell carcinoma who have a CRT treatment scheduled at Roswell Park
• 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

Exclusion criteria

• Participant does not meet the overall Inclusion Criteria for this study
• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Arm I - BBT-CI

Experimental group

Description:

Patients participate in BBT-CI over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks.

Treatment:

Other: Educational Intervention

Other: Questionnaire Administration

Arm II- therapist

Active Comparator group

Description:

Patients meet with therapist over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks.

Treatment:

Other: Counseling

Other: Questionnaire Administration

Observational Study

Experimental group

Description:

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.

Treatment:

Other: Medical Device Usage and Evaluation

Procedure: Biospecimen Collection

Other: Electronic Health Record Review

Other: Questionnaire Administration