NCT00341341

Brief Summary

This study will explore beliefs and knowledge about genetics and smoking among smokers who have a first or second degree relative with advanced lung cancer, and whether their understanding of genetic risk influences their desire to quit smoking. Healthy adult smokers between 18 and 55 years of age who are first or second degree relatives (e.g., siblings, children, grandchildren, nieces, nephews, grandnieces or grandnephews) of a patient with advanced lung cancer who is receiving care at the Moffitt Cancer Center and Research Institute in Tampa, Fla. and the GUMC/LCCC, may be eligible for this study. Participants must be able to complete computer online surveys. Participants log on to a password-protected website to complete online educational sessions and surveys. The educational sessions include information on: 1) the role of smoking and genetics in the development of lung cancer; 2) glutathione S transferase (GSTM1), an enzyme made by the GSTM1 gene that "cleans up" toxins such as cigarette smoke and that may play a role in preventing lung cancer from developing; 3) pros and cons of being tested for GSTM1; and 5) a series of questions and answers about genetic testing. Participants are offered free genetic testing for GSTM1, and those who wish to be tested are sent materials to collect a sample from inside the cheek using a mouth rinse and return it to a laboratory at Duke University Medical Center. They later receive their results online. Participants also complete online surveys that ask about their risk perceptions, beliefs and attitudes related to lung cancer, emotional responses to their relative's diagnosis, smoking history and motivation to quit, reactions to information about smoking and genetic risk, and interest in receiving smoking cessation services. They are asked to review depictions and descriptions of smoking cessation materials offered through a quit smoking program at Duke University Medical Center and to evaluate the extent to which the various materials might be helpful. They are offered additional information among categories they can choose from. Participants are surveyed again by telephone 6 months after completing the online surveys.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
757

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2004

Longer than P75 for all trials

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

Study Start

First participant enrolled

December 7, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2010

Completed
Last Updated

July 2, 2017

Status Verified

July 16, 2010

First QC Date

June 19, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

SmokingSmoking CessationGSTM1Glutathione S. TransferaseLung CancerSmokersGenetic Risk Communication

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The target sample for the study is healthy adult smokers ages 18 to 55 who are first or second degree blood relatives (e.g., siblings, sons, daughters, grandsons, granddaughters, nieces, nephews, grandnieces, grandnephews) of a late stage lung cancer patient (Stage IIIB or IV) who is receiving care at MCC.
  • Aside from age and blood relationship to the lung cancer patient, eligibility criteria also will include the following:
  • No current or previous diagnosis of cancer;
  • Has access and some willingness to use the internet;
  • Is willing to be contacted by NIH study staff;
  • Has a score lower than 14 on the Centers for Epidemiological Survey of Depression (CESD);
  • Is English speaking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Human Genome Research Institute (NHGRI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Alexandrie AK, Nyberg F, Warholm M, Rannug A. Influence of CYP1A1, GSTM1, GSTT1, and NQO1 genotypes and cumulative smoking dose on lung cancer risk in a Swedish population. Cancer Epidemiol Biomarkers Prev. 2004 Jun;13(6):908-14.

    PMID: 15184245BACKGROUND
  • Aspinwall LG, Taylor SE. Effects of social comparison direction, threat, and self-esteem on affect, self-evaluation, and expected success. J Pers Soc Psychol. 1993 May;64(5):708-22. doi: 10.1037//0022-3514.64.5.708.

    PMID: 8505703BACKGROUND
  • Belogubova EV, Togo AV, Karpova MB, Kuligina ESh, Buslova KG, Ulibina JM, Lemehov VG, Romanenko SM, Shutkin VA, Hanson KP, Hirvonen A, Imyanitov EN. A novel approach for assessment of cancer predisposing roles of GSTM1 and GSTT1 genes: use of putatively cancer resistant elderly tumor-free smokers as the referents. Lung Cancer. 2004 Mar;43(3):259-66. doi: 10.1016/j.lungcan.2003.08.019.

    PMID: 15165083BACKGROUND

MeSH Terms

Conditions

Lung NeoplasmsSmokingSmoking Cessation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehaviorHealth Behavior

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

December 7, 2004

Study Completion

July 16, 2010

Last Updated

July 2, 2017

Record last verified: 2010-07-16

Locations