A Smoking, Alcohol, and Depression Intervention for Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00105651
First received: March 16, 2005
Last updated: October 25, 2013
Last verified: February 2007

March 16, 2005
October 25, 2013
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Complete list of historical versions of study NCT00105651 on ClinicalTrials.gov Archive Site
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A Smoking, Alcohol, and Depression Intervention for Head and Neck Cancer
A Smoking, Alcohol, and Depression Intervention for Head and Neck Cancer

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.

Background:

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Cancer
Behavioral: Combined nursing invention
Arm 1
Intervention: Behavioral: Combined nursing invention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
March 2004
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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:

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00105651
IIR 98-500
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Sonia A. Duffy, PhD MS RN VA Ann Arbor Healthcare System
Principal Investigator: Larry Myers, MD North Texas Veterans Healthcare System
Department of Veterans Affairs
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP