Hypertension Clinical Trial
Official title:
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. .
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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