Clinical trial NCT00448344: Family-supported Smoking Cessation for Chronically Ill Veterans
Official title: Family-Supported Smoking Cessation for Chronically Ill Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Neoplasm
Cardiovascular Disease
Pulmonary Disease, Chronic Obstructive
Diabetes Mellitus
Hypertension
Keywords: veterans
smoking cessation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2007-03-16
Enrollment: 471
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. .

Eligibility criteria: 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

Primary outcomes:
measure: The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention
timeFrame: 5 months
Secondary outcomes:
measure: The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up
timeFrame: 12-months follow-up
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Lori Anne Bastian, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bastian LA. If it is as simple as AAAAA B C, why don't we do it? J Gen Intern Med. 2009 Feb;24(2):284-5. doi: 10.1007/s11606-008-0896-2. No abstract available.
citation: Bastian LA, Sherman SE. Effects of the wars on smoking among veterans. J Gen Intern Med. 2010 Feb;25(2):102-3. doi: 10.1007/s11606-009-1224-1. No abstract available.
citation: Rohrer LD, Gierisch JM, Fish LJ, Blakeney JK, Bastian LA. A five-step guide for moving from observational studies to interventional research for women veterans. Womens Health Issues. 2011 Jul-Aug;21(4 Suppl):S98-102. doi: 10.1016/j.whi.2011.05.004. No abstract available.
citation: Fish LJ, Gierisch JM, Stechuchak KM, Grambow SC, Rohrer LD, Bastian LA. Correlates of expected positive and negative support for smoking cessation among a sample of chronically ill veterans. Addict Behav. 2012 Jan;37(1):135-8. doi: 10.1016/j.addbeh.2011.08.013. Epub 2011 Sep 17.
citation: Bastian LA, Fish LJ, Gierisch JM, Rohrer LD, Stechuchak KM, Grambow SC. Comparative effectiveness trial of family-supported smoking cessation intervention versus standard telephone counseling for chronically ill veterans using proactive recruitment. Comparative Effectiveness Research. 2012 Jan 1; 2012(2):45-56.
citation: Bastian LA, Fish LJ, Gierisch JM, Stechuchak KM, Grambow SC, Keefe FJ. Impact of Smoking Cessation on Subsequent Pain Intensity Among Chronically Ill Veterans Enrolled in a Smoking Cessation Trial. J Pain Symptom Manage. 2015 Dec;50(6):822-9. doi: 10.1016/j.jpainsymman.2015.06.012. Epub 2015 Jul 22.