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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00655005
Enrollment
100
Registered
2008-04-09
Start date
2007-05-31
Completion date
2008-05-31
Last updated
2012-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

head and neck cancer

Brief 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.

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.

Interventions

OTHERquestionnaire administration

Newly diagnosed HNC patients

PROCEDUREquality-of-life assessment

following treatment

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Vanderbilt-Ingram Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pilot questionnaire testing of related symptoms, general demographics, pain control, general symptoms, mood, smoking and drinking history, and quality of lifeat time of patient examcollection 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

MeasureTime frameDescription
Time required for questionnaire completion by each patientat time of patient examThe 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 assessmentat time of patient exam
Baseline incidence of symptoms and psychosocial issuesat time of patient exam

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026