A Smoking, Alcohol, and Depression Intervention for Head and Neck Cancer
NCT ID: NCT00105651
Last Updated: 2015-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
128 participants
INTERVENTIONAL
2004-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Alcohol Cessation Among Head and Neck Cancer Survivors
NCT05570851
Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use
NCT00799669
Alcohol and Tobacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support
NCT01652456
Smoking Cessation Treatment for Head & Neck Cancer Patients
NCT01098955
Personalized Alerts and Care Pathways to Prompt Prevention Interventions for Alcohol and Tobacco Users in Primary Care
NCT03108144
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Objectives:
To determine whether a combined intervention for smoking, alcohol intake, and depression improves the QoL of veterans with HN Ca.
Methods:
Patients 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.
Status:
Completed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1
Combined nursing invention
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Combined nursing invention
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Head 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.
Exclusion Criteria:
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
US Department of Veterans Affairs
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sonia A. Duffy, PhD MS RN
Role: PRINCIPAL_INVESTIGATOR
VA Ann Arbor Healthcare System, Ann Arbor, MI
Larry Myers, MD
Role: PRINCIPAL_INVESTIGATOR
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IIR 98-500
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.