Family-supported Smoking Cessation for Chronically Ill Veterans

Not Applicable

Completed

• Conditions: Neoplasm; Chronic Disease; Pulmonary Disease, Chronic Obstructive; Diabetes Mellitus; Hypertension; Cardiovascular Disease
• Interventions: Behavioral: Family-supported; Behavioral: Standard Telephone counseling

• Registration Number: NCT00448344
• Lead Sponsor: US Department of Veterans Affairs

Brief 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. .

Study Timeline

• Study First Submitted: 2007-03-14
• Study First Submitted QC: 2007-03-15
• Study First Posted: 2007-03-16
• Study Start: 2008-02
• Primary Completion: 2010-09
• Study Completion: 2012-07
• Status Verified: 2014-08
• Results First Submitted: 2014-08-13
• Results First Submitted QC: 2014-08-13
• Results First Posted: 2014-08-27
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 471

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Family-supported	Family-supported smoking cessation
Arm 2	Standard Telephone counseling	Standard smoking cessation

Primary Outcome Measures

Name	Time	Method
The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention	5 months	self-reported 7-day point prevalent abstinence

Secondary Outcome Measures

Name	Time	Method
The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up	12-months follow-up	self-reported 7- day point prevalent abstinence

Trial Locations

Locations (1)

Durham VA Medical Center, Durham, NC; 🇺🇸 Durham, North Carolina, United States