Family-supported Smoking Cessation for Chronically Ill Veterans

NCT ID: NCT00448344

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 471 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2012-07-31

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. .

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Family-supported smoking cessation

Group Type: EXPERIMENTAL

Family-supported

Intervention Type: BEHAVIORAL

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

Arm 2

Standard smoking cessation

Group Type: OTHER

Standard Telephone counseling

Intervention Type: BEHAVIORAL

Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions

Interventions

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

Intervention Type: BEHAVIORAL

Standard Telephone counseling

Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions

Intervention Type: BEHAVIORAL

Other Intervention Names

Intervention; Control

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lori Anne Bastian, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Durham VA Medical Center, Durham, NC

Locations

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 19139966 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20077050 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21724150 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21978930 (View on PubMed)

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.

Reference Type: RESULT

Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

Reference Type: DERIVED

PMID: 39868569 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26210348 (View on PubMed)

Other Identifiers

IIR 05-202

Identifier Type: -

Identifier Source: org_study_id