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: August 27, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Chronic Disease
Neoplasm
Cardiovascular Disease
Pulmonary Disease, Chronic Obstructive
Diabetes Mellitus
Hypertension
Behavioral: Family-supported
Behavioral: Standard Telephone counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Family-Supported Smoking Cessation for Chronically Ill Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    self-reported 7-day point prevalent abstinence


Secondary Outcome Measures:
  • The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up [ Time Frame: 12-months follow-up ] [ Designated as safety issue: No ]
    self-reported 7- day point prevalent abstinence


Enrollment: 471
Study Start Date: February 2008
Study Completion Date: July 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Family-supported smoking cessation
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
Arm 2
Standard smoking cessation
Behavioral: Standard Telephone counseling
Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions
Other Name: Control

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448344

Locations
United States, North Carolina
VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Investigators
Principal Investigator: Lori A Bastian, MD MPH VA Connecticut Healthcare System West Haven Campus, West Haven, CT
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00448344     History of Changes
Other Study ID Numbers: IIR 05-202
Study First Received: March 14, 2007
Results First Received: August 13, 2014
Last Updated: August 27, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
veterans
smoking cessation

Additional relevant MeSH terms:
Cardiovascular Diseases
Chronic Disease
Diabetes Mellitus
Hypertension
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Endocrine System Diseases
Glucose Metabolism Disorders
Lung Diseases, Obstructive
Metabolic Diseases
Pathologic Processes
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014