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

Sponsor
US Department of Veterans Affairs (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00105651
Collaborator
(none)
128
2
1
64

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Combined nursing invention
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
A Smoking, Alcohol, and Depression Intervention for Head and Neck Cancer
Actual Study Completion Date :
Mar 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Other: Arm 1

Behavioral: Combined nursing invention

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 VA Ann Arbor Healthcare System, Ann Arbor, MI Ann Arbor Michigan United States 48105
    2 VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX Dallas Texas United States 75216

    Sponsors and Collaborators

    • US Department of Veterans Affairs

    Investigators

    • Principal Investigator: Sonia A. Duffy, PhD MS RN, VA Ann Arbor Healthcare System, Ann Arbor, MI
    • Principal Investigator: Larry Myers, MD, VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    US Department of Veterans Affairs
    ClinicalTrials.gov Identifier:
    NCT00105651
    Other Study ID Numbers:
    • IIR 98-500
    First Posted:
    Mar 17, 2005
    Last Update Posted:
    Apr 7, 2015
    Last Verified:
    Feb 1, 2007
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 7, 2015