NCT00448344

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
471

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2007

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 27, 2014

Completed
Last Updated

April 24, 2015

Status Verified

August 1, 2014

Enrollment Period

2.6 years

First QC Date

March 14, 2007

Results QC Date

August 13, 2014

Last Update Submit

April 6, 2015

Conditions

Keywords

veteranssmoking cessation

Outcome Measures

Primary Outcomes (1)

  • 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

    5 months

Secondary Outcomes (1)

  • The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up

    12-months follow-up

Study Arms (2)

Arm 1

EXPERIMENTAL

Family-supported smoking cessation

Behavioral: Family-supported

Arm 2

OTHER

Standard smoking cessation

Behavioral: Standard Telephone counseling

Interventions

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

Also known as: Intervention
Arm 1

Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions

Also known as: Control
Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related Publications (7)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

    RESULT
  • 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.

  • 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.

MeSH Terms

Conditions

Chronic DiseaseNeoplasmsCardiovascular DiseasesPulmonary Disease, Chronic ObstructiveDiabetes MellitusHypertensionSmoking Cessation

Interventions

Methods

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Dr. Lori Bastian
Organization
VA Connecticut

Study Officials

  • Lori Anne Bastian, MD MPH

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2007

First Posted

March 16, 2007

Study Start

February 1, 2008

Primary Completion

September 1, 2010

Study Completion

July 1, 2012

Last Updated

April 24, 2015

Results First Posted

August 27, 2014

Record last verified: 2014-08

Locations