Family-supported Smoking Cessation for Chronically Ill Veterans
|ClinicalTrials.gov Identifier: NCT00448344|
Recruitment Status : Completed
First Posted : March 16, 2007
Results First Posted : August 27, 2014
Last Update Posted : April 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Disease Neoplasm Cardiovascular Disease Pulmonary Disease, Chronic Obstructive Diabetes Mellitus Hypertension||Behavioral: Family-supported Behavioral: Standard Telephone counseling||Not Applicable|
ANTICIPATED IMPACT(S) ON VETERAN'S HEALTHCARE:
Veterans with chronic disease who continue to smoke exact a significant burden on the VA health care system. Effective smoking cessation programs, that target veterans who continue to smoke after the diagnosis of a smoking-related chronic illness, are needed.
Chronic diseases related to tobacco exposure are common among veterans. Persistent tobacco use after being diagnosed with these diseases decreases quality of life and survival. Yet, 30% of veterans with these conditions continue to smoke. Researchers have found that the social environment is important for smokers. In our current NCI-funded study, 70% of veterans with lung cancer identified at least one family member who smokes and 45% live with a family member that smokes. A family-supported smoking cessation intervention timed to follow a veteran's diagnosis of cancer or heart disease could be effective for helping veterans quit smoking.
The overarching aim of the study is to evaluate in a randomized trial the impact of a family-supported intervention compared to a standard veteran-focused telephone counseling control group to promote smoking cessation among cancer and heart disease patients.
AIM 1: To evaluate the impact of a family-supported intervention on rates of abstinence from cigarettes (self-reported 7-day point prevalent abstinence) at 2 weeks, and 12-month post-treatment follow-ups.
Hypothesis 1: Abstinence rates will be significantly higher among veterans who receive the family-supported intervention than those who receive the standard telephone counseling control.
AIM 2: To evaluate the impact of a family-supported intervention on perceived support for quitting 2 weeks and 12-month post-treatment follow-ups.
Hypothesis 2: Perceived support for quitting smoking will be significantly greater among veterans who receive the family-supported intervention than those who receive the standard telephone counseling control.
AIM 3: To measure the impact of a family-supported intervention on quality of life in veterans 2 weeks, and 12-month post-treatment follow-ups.
Hypothesis 3: Symptom-related quality of life will be significantly greater among veterans who receive the family-supported intervention than those who receive the standard telephone counseling control.
METHODS: Proposed is a two-group design in which 470 veterans who smoke will be randomized to receive:
STANDARD TELEPHONE COUNSELING control including a letter from a VA physician encouraging the patient to quit smoking, nicotine replacement (if not contraindicated), a self-help cessation kit, and 5 standard telephone counseling calls; or FAMILY-SUPPORTED intervention that includes all components of the control arm plus a Family-supported intervention that includes a support skills booklet and an additional telephone counseling protocol focusing on social support. .
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||471 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Family-Supported Smoking Cessation for Chronically Ill Veterans|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||July 2012|
Experimental: Arm 1
Family-supported smoking cessation
Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking
Other Name: Intervention
Standard smoking cessation
Behavioral: Standard Telephone counseling
Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions
Other Name: Control
- The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention [ Time Frame: 5 months ]self-reported 7-day point prevalent abstinence
- The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up [ Time Frame: 12-months follow-up ]self-reported 7- day point prevalent abstinence
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448344
|United States, North Carolina|
|Durham VA Medical Center, Durham, NC|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Lori Anne Bastian, MD MPH||Durham VA Medical Center, Durham, NC|