Family-supported Smoking Cessation for Chronically Ill Veterans

Overview

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.

Full Title of Study: “Family-Supported Smoking Cessation for Chronically Ill Veterans”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2010

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. .

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Arm 1
    • Family-supported smoking cessation
  • Other: Arm 2
    • Standard smoking cessation

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • US Department of Veterans Affairs
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lori Anne Bastian, MD MPH, Principal Investigator, Durham VA Medical Center, Durham, NC

Citations Reporting on Results

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.

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.

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.

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.

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.

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