A Smoking, Alcohol, and Depression Intervention for Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00105651|
Recruitment Status : Completed
First Posted : March 17, 2005
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Behavioral: Combined nursing invention||Not Applicable|
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.
To determine whether a combined intervention for smoking, alcohol intake, and depression improves the QoL of veterans with HN Ca.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|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 :||March 2004|
|Arm 1||Behavioral: Combined nursing invention|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105651
|United States, Michigan|
|VA Ann Arbor Healthcare System, Ann Arbor, MI|
|Ann Arbor, Michigan, United States, 48105|
|United States, Texas|
|VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX|
|Dallas, Texas, United States, 75216|
|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|