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Clinical Trial: A Smoking, Alcohol, and Depression Intervention for Head and Neck Cancer
This study has been completed.
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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
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.
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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