Investigation of Pain and Symptom Burden in Patients With Newly Diagnosed Head and Neck Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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Investigation of Pain and Symptom Burden in Patients With Newly Diagnosed Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Other: questionnaire administration
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of head or neck carcinoma Newly diagnosed disease Able to speak English Able to give informed consent Exclusion Criteria: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire administration|Newly diagnosed HNC patients|
|Procedure: quality-of-life assessment|following treatment|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pilot questionnaire testing of related symptoms, general demographics, pain control, general symptoms, mood, smoking and drinking history, and quality of life | 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. | at time of patient exam | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required for questionnaire completion by each patient | 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. | at time of patient exam | 
| Feasibility and patient burden assessment |  | at time of patient exam | 
| Baseline incidence of symptoms and psychosocial issues |  | at time of patient exam | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head and neck cancer