Family-supported Smoking Cessation for Chronically Ill Veterans
Primary Purpose
Chronic Disease, Neoplasm, Cardiovascular Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-supported
Standard Telephone counseling
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Disease focused on measuring veterans, smoking cessation
Eligibility 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
Sites / Locations
- Durham VA Medical Center, Durham, NC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Arm 1
Arm 2
Arm Description
Family-supported smoking cessation
Standard smoking cessation
Outcomes
Primary Outcome Measures
The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention
self-reported 7-day point prevalent abstinence
Secondary Outcome Measures
The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up
self-reported 7- day point prevalent abstinence
Full Information
NCT ID
NCT00448344
First Posted
March 14, 2007
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00448344
Brief Title
Family-supported Smoking Cessation for Chronically Ill Veterans
Official Title
Family-Supported Smoking Cessation for Chronically Ill Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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. .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Neoplasm, Cardiovascular Disease, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Hypertension
Keywords
veterans, smoking cessation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
471 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Family-supported smoking cessation
Arm Title
Arm 2
Arm Type
Other
Arm Description
Standard smoking cessation
Intervention Type
Behavioral
Intervention Name(s)
Family-supported
Other Intervention Name(s)
Intervention
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Standard Telephone counseling
Other Intervention Name(s)
Control
Intervention Description
Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions
Primary Outcome Measure Information:
Title
The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention
Description
self-reported 7-day point prevalent abstinence
Time Frame
5 months
Secondary Outcome Measure Information:
Title
The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up
Description
self-reported 7- day point prevalent abstinence
Time Frame
12-months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Anne Bastian, MD MPH
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19139966
Citation
Bastian LA. If it is as simple as AAAAA B C, why don't we do it? J Gen Intern Med. 2009 Feb;24(2):284-5. doi: 10.1007/s11606-008-0896-2. No abstract available.
Results Reference
result
PubMed Identifier
20077050
Citation
Bastian LA, Sherman SE. Effects of the wars on smoking among veterans. J Gen Intern Med. 2010 Feb;25(2):102-3. doi: 10.1007/s11606-009-1224-1. No abstract available.
Results Reference
result
PubMed Identifier
21724150
Citation
Rohrer LD, Gierisch JM, Fish LJ, Blakeney JK, Bastian LA. A five-step guide for moving from observational studies to interventional research for women veterans. Womens Health Issues. 2011 Jul-Aug;21(4 Suppl):S98-102. doi: 10.1016/j.whi.2011.05.004. No abstract available.
Results Reference
result
PubMed Identifier
21978930
Citation
Fish LJ, Gierisch JM, Stechuchak KM, Grambow SC, Rohrer LD, Bastian LA. Correlates of expected positive and negative support for smoking cessation among a sample of chronically ill veterans. Addict Behav. 2012 Jan;37(1):135-8. doi: 10.1016/j.addbeh.2011.08.013. Epub 2011 Sep 17.
Results Reference
result
Citation
Bastian LA, Fish LJ, Gierisch JM, Rohrer LD, Stechuchak KM, Grambow SC. Comparative effectiveness trial of family-supported smoking cessation intervention versus standard telephone counseling for chronically ill veterans using proactive recruitment. Comparative Effectiveness Research. 2012 Jan 1; 2012(2):45-56.
Results Reference
result
PubMed Identifier
26210348
Citation
Bastian LA, Fish LJ, Gierisch JM, Stechuchak KM, Grambow SC, Keefe FJ. Impact of Smoking Cessation on Subsequent Pain Intensity Among Chronically Ill Veterans Enrolled in a Smoking Cessation Trial. J Pain Symptom Manage. 2015 Dec;50(6):822-9. doi: 10.1016/j.jpainsymman.2015.06.012. Epub 2015 Jul 22.
Results Reference
derived
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Family-supported Smoking Cessation for Chronically Ill Veterans
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