Family-supported Smoking Cessation for Chronically Ill Veterans

Study Overview
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Brief Summary
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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
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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. .

Official Title
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Family-Supported Smoking Cessation for Chronically Ill Veterans

Conditions
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Chronic Disease, Neoplasm, Cardiovascular Disease, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Hypertension

Intervention / Treatment
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* Behavioral: Family-supported
* Behavioral: Standard Telephone counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in the Durham VA for ongoing care Seen at a DVAMC clinic for care of cancer or cardiovascular disease within the previous 3 months Current smokers and planning to quit smoking in the next 30 days Exclusion Criteria: Active diagnosis of psychosis documented in medical record Does not have access to a telephone Refusal to provide informed consent Severely impaired hearing or speech

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Family-supported smoking cessation | Behavioral: Family-supported<br>* 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<br>* Other names: Intervention;|
| Other: Arm 2<br>Standard smoking cessation | Behavioral: Standard Telephone counseling<br>* Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention | self-reported 7-day point prevalent abstinence | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up | self-reported 7- day point prevalent abstinence | 12-months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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veterans, smoking cessation