Family-supported Smoking Cessation for Chronically Ill Veterans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00448344
First received: March 14, 2007
Last updated: April 15, 2014
Last verified: April 2014

March 14, 2007
April 15, 2014
February 2008
September 2010   (final data collection date for primary outcome measure)
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-months post-treatment follow-ups. [ Time Frame: 2 weeks and 12-months post-treatment follow-ups ] [ Designated as safety issue: No ]
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-months post-treatment follow-ups.
Complete list of historical versions of study NCT00448344 on ClinicalTrials.gov Archive Site
The impact of a family-supported intervention on perceived support for quitting and on quality of life in veterans at 2 weeks and 12-months post-treatment follow-ups. [ Time Frame: 2 weeks and 12-months post-treatment follow-ups ] [ Designated as safety issue: No ]
  • The impact of a family-supported intervention on perceived support for quitting 2 weeks and 12-months post-treatment follow-ups.
  • The impact of a family-supported intervention on quality of life in veterans at 2 weeks and 12-months post-treatment follow-ups.
Not Provided
Not Provided
 
Family-supported Smoking Cessation for Chronically Ill Veterans
Family-Supported Smoking Cessation for Chronically Ill Veterans

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.

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. .

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Disease
  • Neoplasm
  • Cardiovascular Disease
  • Pulmonary Disease, Chronic Obstructive
  • Diabetes Mellitus
  • Hypertension
  • 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
    Other Name: Intervention
  • Behavioral: Standard Telephone counseling
    Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions
    Other Name: Control
  • Experimental: Arm 1
    Family-supported smoking cessation
    Intervention: Behavioral: Family-supported
  • Arm 2
    Standard smoking cessation
    Intervention: Behavioral: Standard Telephone counseling

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
471
July 2012
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00448344
IIR 05-202
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Lori Bastian, MD MPH VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP