NCT01862770

Brief Summary

Background: \- A health event can be a powerful motivator for abrupt behavior changes. For instance, many people who smoke stop after having a heart attack or being diagnosed with cancer. A relative s health event may have a similar effect. For instance, smokers may try to quit after learning that a parent or sibling has lung cancer. Researchers want to study relatives of people with lung cancer to see how the relative s diagnosis affects a person s willingness to quit smoking or have genetic testing. Objectives: \- To study the impact of a relative s lung cancer diagnosis on a person s approach to genetic testing and smoking cessation services. Eligibility: \- Current smokers between 18 and 55 years of age who are close blood relatives of people being treated for lung cancer. Design:

  • Participants will be recruited through telephone surveys. Participants will log on to a password-protected website. The site has two educational sessions and three surveys to complete.
  • Participants will also be offered free genetic testing. The test will see whether they have a gene that can reduce the effectiveness of some cancer treatment drugs. Those who agree to the test will collect a cheek swab sample at home and send the sample in for testing. They will receive the test results through the website.
  • The surveys will ask about risk perceptions and emotional responses to the relative s diagnosis. They will also ask about smoking history, motivation to quit, and reactions to information about smoking and genetic risk.
  • All participants will be able to receive free smoking cessation services.
  • Six months after completing the surveys, participants will have a follow-up phone call. The call will ask whether participants used the smoking cessation services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
507

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

Geographic Reach
1 country

2 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

December 18, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2013

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2016

Completed
Last Updated

April 5, 2018

Status Verified

February 25, 2016

Enrollment Period

11 months

First QC Date

May 23, 2013

Last Update Submit

April 4, 2018

Conditions

Keywords

Lung CancerSmokersGenetic Risk CommunicationSmoking Cessation

Outcome Measures

Primary Outcomes (1)

  • The primary aim of the analyses is to identify for whom genetic testing for lung cancer susceptibility may be a teachable moment to promote behavior change.

    ongoing

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
* ELIGIBILITY CRITERIA: * 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. * 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) * English speaking

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Moffitt Cancer Center

Tampa, Florida, 33647, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, 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 NeoplasmsSmoking Cessation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesHealth BehaviorBehavior

Study Officials

  • Laura M. Koehly, Ph.D.

    National Human Genome Research Institute (NHGRI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2013

First Posted

May 24, 2013

Study Start

December 18, 2012

Primary Completion

November 25, 2013

Study Completion

February 25, 2016

Last Updated

April 5, 2018

Record last verified: 2016-02-25

Locations