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Family-supported Smoking Cessation for Chronically Ill Veterans

US Department of Veterans Affairs (VA) logo

US Department of Veterans Affairs (VA)

Status

Completed

Conditions

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

Treatments

Behavioral: Standard Telephone counseling
Behavioral: Family-supported

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00448344
IIR 05-202

Details and patient eligibility

About

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 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. .

Enrollment

471 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

471 participants in 2 patient groups

Arm 1
Experimental group
Description:
Family-supported smoking cessation
Treatment:
Behavioral: Family-supported
Arm 2
Other group
Description:
Standard smoking cessation
Treatment:
Behavioral: Standard Telephone counseling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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