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


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Clinical Trial: A Smoking, Alcohol, and Depression Intervention for Head and Neck Cancer

This study has been completed.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs

Purpose

Data from the Surveilance, 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.

This study will determine whether a combined intervention for smoking, alcohol consumption and depression improves the QoL of veterans with HN Ca. Patients (n=200) 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 will be recruited to the study and randomized to either usual care (n=100) or the combined intervention (n=100).

Data will be collected on smoking, alcohol consumption, depression and QoL at baseline, 6- and 12- months after the intervention (or non-intervention). The main analyses will consist 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. In order to control for baseline differences between the groups, pretest scores on the same variables and demographic variables (such as tumor site) will be included as covariates. Additional analyses will examine smoking, alcohol intake and depression scores at these same time points. A cost effectiveness analysis will also be conducted.

Condition Treatment or Intervention
Head and Neck Cancer
 Behavior: Combined nursing intervention

MedlinePlus related topics:  Head and Neck Cancer

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Further Study Details: 

Expected Total Enrollment:  128

Study start: October 2000;  Study completion: March 2004

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria include:

Head and Neck Cancer patients who:

  • Screen positive for at least one of the three health problems of smoking, alcohol and depression;
  • Are not pregnant;
  • Are greater than 18 years of age; and
  • Speak english

Exclusion Criteria include patients who:

  • Have metastatic disease (terminal); or
  • Have unstable psychiatric/mental conditions such as suicidal ideation, acute psychosis, severe alcohol dependence or dementia

Location Information


Michigan
      VA Ann Arbor Healthcare System, Ann Arbor,  Michigan,  48113-0170,  United States

More Information

Publications

Duffy SA, Terrell JE, Valenstein M, Ronis DL, Copeland LA, Connors M. Effect of smoking, alcohol, and depression on the quality of life of head and neck cancer patients. Gen Hosp Psychiatry. 2002 May-Jun;24(3):140-7.

Study ID Numbers:  IIR 98-500
Record last reviewed:  March 2005
Last Updated:  March 16, 2005
Record first received:  March 16, 2005
ClinicalTrials.gov Identifier:  NCT00105651
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 2, 2009



Page Updated: December 17, 2004
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