Clinical Trial: Insomnia in Patients Undergoing Chemotherapy and Radiation Therapy for Head and Neck Cancer

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

Official Title: Assessment of Insomnia in Patients With Head and Neck Cancer During Treatment

Brief Summary:

RATIONALE: Learning about insomnia and quality of life in patients undergoing chemotherapy and radiation therapy for cancer may help doctors learn about the effects of treatment and plan the best treatment.

PURPOSE: This clinical trial is studying insomnia in patients undergoing chemotherapy and radiation therapy for head and neck cancer.


Detailed Summary:

OBJECTIVES:

  • To assess the prevalence of insomnia, extent of sleep disturbance, and possible contributing factors to sleep disturbance in head and neck cancer patients undergoing chemoradiotherapy.
  • To evaluate the relationships between insomnia and symptom burden, quality of life, mood, fatigue, and tumor/treatment variables in these patients.

OUTLINE: Patients complete a demographic survey and a questionnaire packet comprising The Pittsburgh Sleep Quality Index, The Head and Neck Symptom Survey, Profile of Mood States, Suspected Causes of Insomnia Survey, and a Quality of Life Survey on day 1 of chemoradiotherapy to obtain baseline data on sleep quality, possible causes of sleep disruption, head and neck symptoms, mood state, fatigue, quality of life, and patient demographics. Questionnaires are administered weekly thereafter during therapy visits for up to 6-7 weeks and take 15-30 minutes to complete.

Medical records are reviewed to obtain information regarding medications and tumor- and treatment-related variables.


Sponsor: Vanderbilt University

Current Primary Outcome: Relationships between insomnia and symptom burden, quality of life, mood, fatigue, and tumor/treatment variables as assessed by general demographics, The Head and Neck Symptom Survey, Quality of Life Survey, and Profile of Mood States [ Time Frame: in patient ]

patient given survey while in hospital.


Original Primary Outcome:

  • Prevalence of insomnia, extent of sleep disturbance, and the possible contributing factors to sleep disturbance as assessed by the Pittsburgh Sleep Quality Index and the Suspected Causes of Insomnia Survey
  • Relationships between insomnia and symptom burden, quality of life, mood, fatigue, and tumor/treatment variables as assessed by general demographics, The Head and Neck Symptom Survey, Quality of Life Survey, and Profile of Mood States


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Vanderbilt University

Dates:
Date Received: February 14, 2008
Date Started: July 2007
Date Completion:
Last Updated: June 15, 2014
Last Verified: June 2014