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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655005
• Other study ID #: VICC SUPP 0723
• Secondary ID: VU-VICC-SUPP-072
• Status: Completed
• Phase: N/A
• First received: April 8, 2008
• Last updated: September 7, 2012
• Start date: May 2007
• Est. completion date: May 2008

Study information

• Verified date: September 2012
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• questionnaire administration
Newly diagnosed HNC patients

Procedure:
• quality-of-life assessment
following treatment

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Feasibility and patient burden assessment		at time of patient exam	No
Secondary	Baseline incidence of symptoms and psychosocial issues		at time of patient exam	No