Chronic DiseaseNCT00448344
Family-supported Smoking Cessation for Chronically Ill Veterans
A study testing Family-supported and Standard Telephone counseling in people with Chronic Disease and Neoplasm, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease, Neoplasm, Cardiovascular Disease
- What is being tested?
- Family-supported and Standard Telephone counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 471 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
About this study
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.
Read the 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. .
- Conditions
- Chronic Disease, Neoplasm, Cardiovascular Disease, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Hypertension
- Being tested
- Family-supported, Standard Telephone counseling
- Keywords
- veterans, smoking cessation
- Medical subject headings
- Chronic Disease, Neoplasms, Cardiovascular Diseases, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Hypertension, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-supportedBehavioural
Also called Intervention
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 Telephone counselingBehavioural
Also called Control
Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Family-supported smoking cessation Receives: Behavioral: Family-supported |
| Arm 2 | Other | Standard smoking cessation Receives: Behavioral: Standard Telephone counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 months
Secondary outcomes (1)
The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up
self-reported 7- day point prevalent abstinence
Measured: 12-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2007 (estimated)
- Study startFeb 2008
- Primary completionSep 2010
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lori Anne Bastian, MD MPH, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448344
- Sponsor's protocol ID
- IIR 05-202
- Status last verified
- Aug 2014
- First submitted
- 14 Mar 2007
- Last updated
- 24 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 19139966Bastian 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.
PubMed 20077050Rohrer 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.
PubMed 21724150Fish 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.
PubMed 21978930Bastian 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.
Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
PubMed 39868569Bastian 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.
PubMed 26210348
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Supported Smoking Cessation for Chronically Ill Veterans
- ClinicalTrials.gov ID
- NCT00448344
- Acronym / sponsor ID
- IIR 05-202
- Conditions
- Chronic Disease, Neoplasm, Cardiovascular Disease, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Hypertension
- Keywords
- veterans, smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Feb 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 16 Mar 2007 (estimated)
- Results
- Posted 27 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Family-supportedFamily-supported smoking cessation |
| Arm 2 | Other | Behavioral: Standard Telephone counselingStandard smoking cessation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-supportedAlso: InterventionGroup 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 | Behavioural | Arm 1 |
| Standard Telephone counselingAlso: ControlGroup receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions | Behavioural | Arm 2 |
Primary outcome
The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention
Time frame: 5 months
self-reported 7-day point prevalent abstinence
1 secondary outcome
The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up
Time frame: 12-months follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19139966Bastian 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 publication: PubMed 20077050Bastian 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 publication: PubMed 21724150Rohrer 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 publication: PubMed 21978930Fish 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 publicationBastian 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.
- Derived from this study: PubMed 39868569Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
- Derived from this study: PubMed 26210348Bastian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Anne Bastian, MD MPH principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-supported and Standard Telephone counseling in people with Chronic Disease and Neoplasm, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00448344, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.