|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00448344 |
Purpose
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 | Intervention |
|---|---|
|
Chronic Disease Neoplasm Cardiovascular Disease |
Behavioral: Family-supported Behavioral: Standard Telephone counseling |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Family-Supported Smoking Cessation for Chronically Ill Veterans |
| Estimated Enrollment: | 470 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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
|
|
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
|
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. .
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lesley Rohrer | (919) 668-0305 | lesley.rohrer@va.gov |
| Contact: Lori Bastian, MD MPH | (919) 286-6936 | Lori.Bastian@va.gov |
| United States, North Carolina | |
| VA Medical Center | Recruiting |
| Durham, North Carolina, United States, 27705 | |
| Contact: Kathy L Weatherspoon 919-286-6936 Kathy.weatherspoon@va.gov | |
| Contact: Susan B Armstrong (919) 286-6936 beth.armstrong@med.va.gov | |
| Sub-Investigator: Hayden B. Bosworth, PhD | |
| Principal Investigator: Lori Bastian, MD MPH | |
| Principal Investigator: | Lori Bastian, MD MPH | Department of Veterans Affairs |
More Information
| Responsible Party: | Department of Veterans Affairs ( Bastian, Lori - Principal Investigator ) |
| Study ID Numbers: | IIR 05-202 |
| Study First Received: | March 14, 2007 |
| Last Updated: | November 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00448344 |
| Health Authority: | United States: Federal Government |
|
veterans smoking cessation |
|
Nicotine polacrilex Smoking Nicotine Chronic Disease |
|
Disease Attributes Neoplasms Pathologic Processes Cardiovascular Diseases |
