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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00105651
Enrollment
128
Registered
2005-03-17
Start date
Unknown
Completion date
2004-03-31
Last updated
2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALCombined nursing invention

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026