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Family-Supported Smoking Cessation for Chronically Ill Veterans


N/A
18 Years
N/A
Not Enrolling
Both
Chronic Disease, Neoplasm, Cardiovascular Disease, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Hypertension

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Trial Information

Family-Supported Smoking Cessation for Chronically Ill Veterans


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. .


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

2 weeks and 12-months post-treatment follow-ups

Safety Issue:

No

Principal Investigator

Lori Bastian, MD MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Authority:

United States: Federal Government

Study ID:

IIR 05-202

NCT ID:

NCT00448344

Start Date:

February 2008

Completion Date:

July 2012

Related Keywords:

  • Chronic Disease
  • Neoplasm
  • Cardiovascular Disease
  • Pulmonary Disease, Chronic Obstructive
  • Diabetes Mellitus
  • Hypertension
  • veterans
  • smoking cessation
  • Neoplasms
  • Cardiovascular Diseases
  • Chronic Disease
  • Diabetes Mellitus
  • Hypertension
  • Lung Diseases
  • Respiration Disorders
  • Pulmonary Disease, Chronic Obstructive
  • Smoking

Name

Location

VA Medical CenterDurham, North Carolina  27705