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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00655005
First received: April 8, 2008
Last updated: September 7, 2012
Last verified: September 2012
  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
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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 Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • Time required for questionnaire completion by each patient [ Time Frame: at time of patient exam ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Baseline incidence of symptoms and psychosocial issues [ Time Frame: at time of patient exam ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: May 2007
Study Completion Date: May 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: questionnaire administration
    Newly diagnosed HNC patients
    Other Name: Non specified
    Procedure: quality-of-life assessment
    following treatment
    Other Name: Non specified
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
Sampling Method:   Non-Probability Sample
Study Population

Newly diagnosed HNC patients.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Principal Investigator: Barbara Murphy, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: Barbara Murphy, MD, Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00655005     History of Changes
Other Study ID Numbers: VICC SUPP 0723, VU-VICC-SUPP-0723, VU-VICC-070493
Study First Received: April 8, 2008
Last Updated: September 7, 2012
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt-Ingram Cancer Center:
head and neck cancer

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

ClinicalTrials.gov processed this record on August 21, 2014