Trials / Completed
CompletedNCT00448344
Family-supported Smoking Cessation for Chronically Ill Veterans
Family-Supported Smoking Cessation for Chronically Ill Veterans
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 471 (actual)
- Sponsor
- US Department of Veterans Affairs · Federal
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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. BACKGROUND/RATIONALE: 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. OBJECTIVES: 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. .
Conditions
- Chronic Disease
- Neoplasm
- Cardiovascular Disease
- Pulmonary Disease, Chronic Obstructive
- Diabetes Mellitus
- Hypertension
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Family-supported | 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 |
| BEHAVIORAL | Standard Telephone counseling | Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2010-09-01
- Completion
- 2012-07-01
- First posted
- 2007-03-16
- Last updated
- 2015-04-24
- Results posted
- 2014-08-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00448344. Inclusion in this directory is not an endorsement.