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Sleep and Circadian Rhythm Study in Head and Neck Cancer Patients

NCT05099952 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-01-12

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of cheek cell and blood samples

OTHER

Counseling

Meet with therapist

OTHER

Educational Intervention

Participate in BBT-CI sessions

OTHER

Electronic Health Record Review

Medical records are reviewed

OTHER

Medical Device Usage and Evaluation

Wear actigraphy watch

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • Fangyi Gu · Roswell Park Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2025-12-15
Completion
2026-12-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05099952 on ClinicalTrials.gov