Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-21 @ 3:00 PM
Study NCT ID:
NCT00655005
Status:
COMPLETED
Last Update Posted:
2012-09-10
First Post:
2008-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Pain and Symptom Burden in Patients With Newly Diagnosed Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-07', 'studyFirstSubmitDate': '2008-04-08', 'studyFirstSubmitQcDate': '2008-04-08', 'lastUpdatePostDateStruct': {'date': '2012-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pilot questionnaire testing of related symptoms, general demographics, pain control, general symptoms, mood, smoking and drinking history, and quality of life', 'timeFrame': 'at time of patient exam', 'description': 'collection of the following data from newly diagnosed HNC patients:\n\n* head and neck cancer-related symptoms • general demographics • pain control\n* general symptoms • mood • smoking and drinking history • quality of life\n\nQuestions will be identified that may be unclear or difficult for patients to understand for future revision.'}], 'secondaryOutcomes': [{'measure': 'Time required for questionnaire completion by each patient', 'timeFrame': 'at time of patient exam', 'description': "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.\n\nWhen 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."}, {'measure': 'Feasibility and patient burden assessment', 'timeFrame': 'at time of patient exam'}, {'measure': 'Baseline incidence of symptoms and psychosocial issues', 'timeFrame': 'at time of patient exam'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['head and neck cancer'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n* To identify questions that may be unclear or difficult for patients to understand.\n* To determine the time required for each patient to complete the questionnaire and assess the feasibility and burden to the patient.\n* To determine the baseline incidence of symptoms and psychosocial issues in these patients.\n\nOUTLINE: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed HNC patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of head or neck carcinoma\n\n * Newly diagnosed disease\n* Able to speak English\n* Able to give informed consent\n\nExclusion Criteria:\n\nNot specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00655005', 'briefTitle': 'Investigation of Pain and Symptom Burden in Patients With Newly Diagnosed Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'Investigation of Pain and Symptom Burden in Patients With Newly Diagnosed Head and Neck Cancer', 'orgStudyIdInfo': {'id': 'VICC SUPP 0723'}, 'secondaryIdInfos': [{'id': 'VU-VICC-SUPP-0723'}, {'id': 'VU-VICC-070493'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'questionnaire administration', 'type': 'OTHER', 'otherNames': ['Non specified'], 'description': 'Newly diagnosed HNC patients'}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'otherNames': ['Non specified'], 'description': 'following treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232-6838', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Barbara Murphy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist', 'investigatorFullName': 'Barbara Murphy, MD', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}