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Developing a Questionnaire to Collect Information About Symptoms, Pain Control, Mood, and Quality of Life From Patients With Newly Diagnosed Head and Neck Cancer
This study is ongoing, but not recruiting participants.
First Received: April 8, 2008   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00655005
  Purpose

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 Intervention
Head and Neck Cancer
Other: questionnaire administration
Procedure: quality-of-life assessment

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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Data collecting questionnaire testing of related symptoms, general demographics, pain control, general symptoms, mood, smoking and drinking history, and quality of life [ Designated as safety issue: No ]
  • Time required for questionnaire completion by each patient [ Designated as safety issue: No ]
  • Feasibility and patient burden assessment [ Designated as safety issue: No ]
  • Baseline incidence of symptoms and psychosocial issues [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2007
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of head or neck carcinoma

    • Newly diagnosed disease

PATIENT CHARACTERISTICS:

  • Able to speak English
  • Able to give informed consent

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655005

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: Brittany Holmes Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000583597, VU-VICC-SUPP-0723, VU-VICC-070493
Study First Received: April 8, 2008
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00655005     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
head and neck cancer

Study placed in the following topic categories:
Head and Neck Neoplasms
Quality of Life
Pain

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on September 09, 2009