Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT00105651
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Smoking, Alcohol, and Depression Intervention for Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'completionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2005-03-16', 'studyFirstSubmitQcDate': '2005-03-16', 'lastUpdatePostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-03-17', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '16036280', 'type': 'RESULT', 'citation': 'Lambert MT, Terrell JE, Copeland LA, Ronis DL, Duffy SA. Cigarettes, alcohol, and depression: characterizing head and neck cancer survivors in two systems of care. Nicotine Tob Res. 2005 Apr;7(2):233-41. doi: 10.1080/14622200500055418.'}, {'pmid': '15210560', 'type': 'RESULT', 'citation': 'Taylor JC, Terrell JE, Ronis DL, Fowler KE, Bishop C, Lambert MT, Myers LL, Duffy SA, Bradford CR, Chepeha DB, Hogikyan ND, Prince ME, Teknos TN, Wolf GT; University of Michigan Head and Neck Cancer Team. Disability in patients with head and neck cancer. Arch Otolaryngol Head Neck Surg. 2004 Jun;130(6):764-9. doi: 10.1001/archotol.130.6.764.'}, {'pmid': '16785412', 'type': 'RESULT', 'citation': 'Cheng SS, Terrell JE, Bradford CR, Ronis DL, Fowler KE, Prince ME, Teknos TN, Wolf GT, Duffy SA. Variables associated with feeding tube placement in head and neck cancer. Arch Otolaryngol Head Neck Surg. 2006 Jun;132(6):655-61. doi: 10.1001/archotol.132.6.655.'}, {'pmid': '15096421', 'type': 'RESULT', 'citation': 'Terrell JE, Ronis DL, Fowler KE, Bradford CR, Chepeha DB, Prince ME, Teknos TN, Wolf GT, Duffy SA. Clinical predictors of quality of life in patients with head and neck cancer. Arch Otolaryngol Head Neck Surg. 2004 Apr;130(4):401-8. doi: 10.1001/archotol.130.4.401.'}, {'pmid': '12062138', 'type': 'RESULT', 'citation': 'Duffy SA, Terrell JE, Valenstein M, Ronis DL, Copeland LA, Connors M. Effect of smoking, alcohol, and depression on the quality of life of head and neck cancer patients. Gen Hosp Psychiatry. 2002 May-Jun;24(3):140-7. doi: 10.1016/s0163-8343(02)00180-9.'}, {'pmid': '16420213', 'type': 'RESULT', 'citation': 'Duffy SA, Jackson FC, Schim SM, Ronis DL, Fowler KE. Racial/ethnic preferences, sex preferences, and perceived discrimination related to end-of-life care. J Am Geriatr Soc. 2006 Jan;54(1):150-7. doi: 10.1111/j.1532-5415.2005.00526.x.'}, {'pmid': '17329608', 'type': 'RESULT', 'citation': 'Duffy SA, Ronis DL, Valenstein M, Fowler KE, Lambert MT, Bishop C, Terrell JE. Depressive symptoms, smoking, drinking, and quality of life among head and neck cancer patients. Psychosomatics. 2007 Mar-Apr;48(2):142-8. doi: 10.1176/appi.psy.48.2.142.'}, {'pmid': '17119047', 'type': 'RESULT', 'citation': 'Duffy SA, Ronis DL, Valenstein M, Lambert MT, Fowler KE, Gregory L, Bishop C, Myers LL, Blow FC, Terrell JE. A tailored smoking, alcohol, and depression intervention for head and neck cancer patients. Cancer Epidemiol Biomarkers Prev. 2006 Nov;15(11):2203-8. doi: 10.1158/1055-9965.EPI-05-0880.'}, {'pmid': '17040147', 'type': 'RESULT', 'citation': "Duffy SA, Ronis D, Fowler K, Schim SM, Jackson FC. Differences in veterans' and nonveterans' end-of-life preferences: a pilot study. J Palliat Med. 2006 Oct;9(5):1099-105. doi: 10.1089/jpm.2006.9.1099."}, {'pmid': '18509185', 'type': 'RESULT', 'citation': 'Karvonen-Gutierrez CA, Ronis DL, Fowler KE, Terrell JE, Gruber SB, Duffy SA. Quality of life scores predict survival among patients with head and neck cancer. J Clin Oncol. 2008 Jun 1;26(16):2754-60. doi: 10.1200/JCO.2007.12.9510.'}]}, 'descriptionModule': {'briefSummary': 'Data from the Surveillance, Epidemiology and End Results (SEER) cancer registry indicates that head and neck cancers (HN Ca) are nearly twice as common in veterans as non-veterans. HN Ca patients are at an increased risk for smoking, alcohol consumption and depression, all of which contribute to a further decline in their quality of life (QoL). In the HN Ca population, diagnosis and treatment of smoking, alcohol intake and depression are sub-optimal, thereby affecting QoL and survival. Numerous studies have documented that smoking, alcohol and depression are interrelated and research on multi-modal interventions has been suggested.', 'detailedDescription': 'Background:\n\nData from the Surveillance, Epidemiology and End Results (SEER) cancer registry indicates that head and neck cancers (HN Ca) are nearly twice as common in veterans as non-veterans. HN Ca patients are at an increased risk for smoking, alcohol consumption and depression, all of which contribute to a further decline in their quality of life (QoL). In the HN Ca population, diagnosis and treatment of smoking, alcohol intake and depression are sub-optimal, thereby affecting QoL and survival. Numerous studies have documented that smoking, alcohol and depression are interrelated and research on multi-modal interventions has been suggested.\n\nObjectives:\n\nTo determine whether a combined intervention for smoking, alcohol intake, and depression improves the QoL of veterans with HN Ca.\n\nMethods:\n\nPatients from three VA medical centers (Ann Arbor, MI; Dallas, TX; Gainesville, FL) who have at least one of the three disorders of smoking, drinking and depression were randomized to either usual care or the combined intervention. Data was collected on smoking, alcohol consumption, depression and QoL at baseline, 6- and 12- months after the intervention (or non-intervention). The main analyses consisted of analysis of covariance (ANCOVA) to compare the scores on the SF-36 mental health scores and on the emotional domain of Head and Neck Quality of Life Questionnaire between the experimental and control group at 6- and 12- month follow up. Additional analyses examineded smoking, alcohol intake, and depression scores at these same time points.\n\nStatus:\n\nCompleted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHead and Neck Cancer patients who: 1) screen positive for at least one of the three health problems of smoking, alcohol and depression; 2) are not pregnant; 3) are greater than 18 years of age; and 4) speak english. Exclusion criteria include patients who: 1) have metastatic disease (terminal); or 2) have unstable psychiatric/mental conditions such as suicidal ideation, acute psychosis, severe alcohol dependence or dementia.\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT00105651', 'briefTitle': 'A Smoking, Alcohol, and Depression Intervention for Head and Neck Cancer', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'A Smoking, Alcohol, and Depression Intervention for Head and Neck Cancer', 'orgStudyIdInfo': {'id': 'IIR 98-500'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm 1', 'interventionNames': ['Behavioral: Combined nursing invention']}], 'interventions': [{'name': 'Combined nursing invention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'VA Ann Arbor Healthcare System, Ann Arbor, MI', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Sonia A. Duffy, PhD MS RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, MI'}, {'name': 'Larry Myers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}