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


N/A
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

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


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.


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:

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Principal Investigator

Sonia A. Duffy, PhD MS RN

Investigator Role:

Principal Investigator

Investigator Affiliation:

VA Ann Arbor Healthcare System

Authority:

United States: Federal Government

Study ID:

IIR 98-500

NCT ID:

NCT00105651

Start Date:

Completion Date:

March 2004

Related Keywords:

  • Cancer
  • Depression
  • Depressive Disorder
  • Head and Neck Neoplasms

Name

Location

VA Ann Arbor Healthcare System Ann Arbor, Michigan  48113
VA North Texas Health Care System Dallas, Texas  75216