Investigation of Pain and Symptom Burden in Patients With Newly Diagnosed Head and Neck Cancer
3 other identifiers
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2007
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 8, 2008
CompletedFirst Posted
Study publicly available on registry
April 9, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedSeptember 10, 2012
September 1, 2012
10 months
April 8, 2008
September 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pilot questionnaire testing of related symptoms, general demographics, pain control, general symptoms, mood, smoking and drinking history, and quality of life
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.
at time of patient exam
Secondary Outcomes (3)
Time required for questionnaire completion by each patient
at time of patient exam
Feasibility and patient burden assessment
at time of patient exam
Baseline incidence of symptoms and psychosocial issues
at time of patient exam
Interventions
Eligibility Criteria
Newly diagnosed HNC patients.
You may qualify if:
- Diagnosis of head or neck carcinoma
- Newly diagnosed disease
- Able to speak English
- Able to give informed consent
You may not qualify if:
- Not specified
- PRIOR CONCURRENT THERAPY:
- Not specified
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt-Ingram Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Murphy, MD
Vanderbilt-Ingram Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist
Study Record Dates
First Submitted
April 8, 2008
First Posted
April 9, 2008
Study Start
May 1, 2007
Primary Completion
March 1, 2008
Study Completion
May 1, 2008
Last Updated
September 10, 2012
Record last verified: 2012-09