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

NCT ID: NCT00655005

Last Updated: 2012-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-05-31

Brief Summary

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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

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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.

Conditions

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Head and Neck Cancer

Keywords

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head and neck cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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questionnaire administration

Newly diagnosed HNC patients

Intervention Type OTHER

quality-of-life assessment

following treatment

Intervention Type PROCEDURE

Other Intervention Names

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Non specified Non specified

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Barbara Murphy, MD

Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara Murphy, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

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Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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VU-VICC-SUPP-0723

Identifier Type: -

Identifier Source: secondary_id

VU-VICC-070493

Identifier Type: -

Identifier Source: secondary_id

VICC SUPP 0723

Identifier Type: -

Identifier Source: org_study_id