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Completed

NCT Number: NCT00105651

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.

Completed

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined nursing invention

Behavioral

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study completion
2004
First posted
Mar 17, 2005
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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