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OpenTrials
Completed

NCT Number: NCT00655005

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

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

Newly diagnosed HNC patients

Other names: Non specified

quality-of-life assessment

Procedure

following treatment

Other names: Non specified

Primary outcomes

  1. 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

    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 outcomes

  1. Time required for questionnaire completion by each patient

    Time frame: 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.

  2. Feasibility and patient burden assessment

    Time frame: at time of patient exam

  3. Baseline incidence of symptoms and psychosocial issues

    Time frame: at time of patient exam

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 9, 2008
Registry last updated
Sep 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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