Investigation of Pain and Symptom Burden in Patients With Newly Diagnosed Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00655005|
Recruitment Status : Completed
First Posted : April 9, 2008
Last Update Posted : September 10, 2012
RATIONALE: Collecting information by questionnaire about the quality of life of patients with head and neck cancer may help doctors learn more about the disease.
PURPOSE: This clinical trial is testing a questionnaire for assessing pain control, head and neck symptoms, and general symptoms of illness, demographics, moods, alcohol and tobacco history, and quality of life related to cancer in patients with newly diagnosed head and neck cancer.
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer||Other: questionnaire administration Procedure: quality-of-life assessment|
- To pilot test a questionnaire measuring the collection of the following data from patients with newly diagnosed head and neck cancer: head and neck cancer-related symptoms, general demographics, pain control, general symptoms, mood, smoking and drinking history, and quality of life.
- To identify questions that may be unclear or difficult for patients to understand.
- To determine the time required for each patient to complete the questionnaire and assess the feasibility and burden to the patient.
- To determine the baseline incidence of symptoms and psychosocial issues in these patients.
OUTLINE: Patients complete a timed questionnaire comprising questions of head and neck symptoms, demographic information, pain control, symptom control, mood, smoking and drinking history, and anxiety and depression under the supervision of the investigator.
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Investigation of Pain and Symptom Burden in Patients With Newly Diagnosed Head and Neck Cancer|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||May 2008|
Other: questionnaire administration
- Pilot questionnaire testing of related symptoms, general demographics, pain control, general symptoms, mood, smoking and drinking history, and quality of life [ Time Frame: at time of patient exam ]
collection of the following data from newly diagnosed HNC patients:
- head and neck cancer-related symptoms • general demographics • pain control
- general symptoms • mood • smoking and drinking history • quality of life
Questions will be identified that may be unclear or difficult for patients to understand for future revision.
- Time required for questionnaire completion by each patient [ Time Frame: at time of patient exam ]
The investigator will verbally explain the purpose of the study using a script (provided with this packet) and obtain verbal consent from the patient. The questionnaire will be handed to the patient with instructions on how to complete it. The investigator will remain available in the room to address any concerns regarding the questionnaire and to time how long the patient takes to complete the survey.
When the patient has completed the questionnaire, the investigator will review it for completeness with the patient. The patient's participation in the study ends at this time.
- Feasibility and patient burden assessment [ Time Frame: at time of patient exam ]
- Baseline incidence of symptoms and psychosocial issues [ Time Frame: at time of patient exam ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655005
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Barbara Murphy, MD||Vanderbilt-Ingram Cancer Center|