Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448344
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2007-03-14
Brief Title:
Family-supported Smoking Cessation for Chronically Ill Veterans
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Family-Supported Smoking Cessation for Chronically Ill Veterans
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
ANTICIPATED IMPACTS ON VETERANS 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
BACKGROUNDRATIONALE
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 veterans 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
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
BACKGROUNDRATIONALE
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 veterans 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None