Family-supported Smoking Cessation for Chronically Ill Veterans

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00448344
• Collaborator: (none)
• Enrollment: 471
• Location: 1
• Arms: 2
• Duration (Months): 53
• Patients Per Site Per Month: 8.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Disease; Neoplasm; Cardiovascular Disease; Pulmonary Disease, Chronic Obstructive; Diabetes Mellitus; Hypertension	Behavioral: Family-supported; Behavioral: Standard Telephone counseling	N/A

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. .

Study Design

• Study Type: Interventional
• Actual Enrollment: 471 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Family-Supported Smoking Cessation for Chronically Ill Veterans
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Family-supported smoking cessation	Behavioral: Family-supported; 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; Other Names: Intervention
Other: Arm 2 Standard smoking cessation	Behavioral: Standard Telephone counseling; Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions; Other Names: Control

Outcome Measures

Primary Outcome Measures

1. The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention [5 months]

   self-reported 7-day point prevalent abstinence

Secondary Outcome Measures

1. The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up [12-months follow-up]

   self-reported 7- day point prevalent abstinence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Durham VA Medical Center, Durham, NC	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: Lori Anne Bastian, MD MPH, Durham VA Medical Center, Durham, NC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00448344
• Other Study ID Numbers: IIR 05-202
• First Posted: Mar 16, 2007
• Last Update Posted: Apr 24, 2015
• Last Verified: Aug 1, 2014

• Keywords provided by US Department of Veterans Affairs: veterans; smoking cessation
• Additional relevant MeSH terms: Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases; Chronic Disease

Study Results

Participant Flow

Arm/Group Title	Family-supported Smoking Cessation	Standard Smoking Cessation
Arm/Group Description	Family-supported smoking cessation Family-supported: 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	Standard smoking cessation Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions
Period Title: Overall Study
STARTED	235	236
COMPLETED	205	200
NOT COMPLETED	30	36

Baseline Characteristics

Arm/Group Title	Arm 1	Arm 2	Total
Arm/Group Description	Family-supported smoking cessation Family-supported: 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	Standard smoking cessation Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions	Total of all reporting groups
Overall Participants	235	236	471
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.1 (8)	59.2 (7.7)	59.2 (7.9)
Sex: Female, Male (Count of Participants)
Female	21 8.9%	19 8.1%	40 8.5%
Male	214 91.1%	217 91.9%	431 91.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	4 1.7%	7 3%	11 2.3%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	1 0.4%	1 0.2%
Black or African American	92 39.1%	96 40.7%	188 39.9%
White	130 55.3%	121 51.3%	251 53.3%
More than one race	8 3.4%	7 3%	15 3.2%
Unknown or Not Reported	1 0.4%	4 1.7%	5 1.1%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	Family-supported smoking cessation Family-supported: 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	Standard smoking cessation Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions
Measure Participants	235	236
Number [percentage of participants that quit]	19.8 8.4%	22.0 9.3%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	Family-supported smoking cessation Family-supported: 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	Standard smoking cessation Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions
Measure Participants	235	236
Number [percentage of participants that quit]	22.4 9.5%	22.4 9.5%

Adverse Events

Arm/Group Title	Arm 1		Arm 2
Arm/Group Description	Family-supported smoking cessation Family-supported: 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		Standard smoking cessation Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions
All Cause Mortality
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/235 (3%)		13/236 (5.5%)
Cardiac disorders
deceased during study	7/235 (3%)		13/236 (5.5%)
Other (Not Including Serious) Adverse Events
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/235 (0%)		0/236 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.