NCT00345891

Brief Summary

The purpose of this study is to evaluate the impact of delivering a coping-focused intervention as an adjunct to a self-help program to promote smoking cessation among relatives of lung cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
496

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

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

Study Start

First participant enrolled

June 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 25, 2014

Status Verified

May 1, 2010

Enrollment Period

3.5 years

First QC Date

June 27, 2006

Last Update Submit

July 23, 2014

Conditions

Keywords

Lung neoplasmsFamilyStress

Outcome Measures

Primary Outcomes (1)

  • 7-day point-prevalence abstinence at 2 weeks and 6 month follow-up

Secondary Outcomes (1)

  • 7-day point-prevalence abstinence at the 12-month follow-up and prolonged abstinence

Interventions

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of lung cancer
  • Ages 18 or older
  • Able to consent
  • Patient has given consent to contact the family member
  • Ages 18 or older
  • Speaks and reads English
  • Cognitively able to give consent to participate
  • Has access to a telephone
  • Smoked at least 100 cigarettes in his/her life
  • Smoked any cigarettes in the prior 7 days at screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

H. Lee Moffitt Cancer Center & Research Institute Thoracic Oncology Program

Tampa, Florida, 33612, United States

Location

UNC Chapel Hill Multidisciplinary Thoracic Oncology Program

Chapel Hill, North Carolina, 27599, United States

Location

Durham VAMC Medical Thoracic Oncology Clinic

Durham, North Carolina, 27705, United States

Location

Duke University Medical Center Thoracic Oncology Program

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

  • 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, Peterson BL, Biddle AK, Garst J, Lyna P, Molner S, Bepler G, Kelley M, Keefe FJ, McBride CM. Assessment of the impact of adjunctive proactive telephone counseling to promote smoking cessation among lung cancer patients' social networks. Am J Health Promot. 2013 Jan-Feb;27(3):181-90. doi: 10.4278/ajhp.101122-QUAN-387.

MeSH Terms

Conditions

Smoking CessationLung Neoplasms

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Lori A Bastian, MD, MPH

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 27, 2006

First Posted

June 29, 2006

Study Start

June 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

July 25, 2014

Record last verified: 2010-05

Locations