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

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00655005
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2008-03
• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-04-08
• Study First Posted: 2008-04-09
• Study Completion: 2008-05
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-07
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pilot questionnaire testing of related symptoms, general demographics, pain control, general symptoms, mood, smoking and drinking history, and quality of life	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.

Secondary Outcome Measures

Name	Time	Method
Time required for questionnaire completion by each patient	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	at time of patient exam
Baseline incidence of symptoms and psychosocial issues	at time of patient exam

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States