Effect of Lung Cancer Diagnoses on Family Behaviors

Sponsor
National Human Genome Research Institute (NHGRI) (NIH)
Overall Status
Completed
CT.gov ID
NCT01862770
Collaborator
(none)
507
2
38.2
253.5
6.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The overarching objective of this observational prospective Family Risk & Lung Cancer Study is to evaluate the impact of a loved one s lung cancer diagnosis on relative s seeking and processing of information related to risks of smoking, genetic susceptibility, and their receptivity to smoking cessation services. We plan to recruit 150 relatives of lung cancer patients who are receiving care at H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida. First- or second-degree blood relatives who are current smokers between the ages 18 to 55 will be eligible for the study. Because these relatives will be living throughout the United States, a web-based research protocol will be employed. A nurse recruiter will approach patients at Moffitt and assess their willingness to do a telephone survey to enumerate their relatives who smoke and be asked to give permission to contact none, some or all of these relatives. These survey contacts with patients and contacts with relatives for screening and recruitment will be conducted in partnership with an ongoing recruitment activities for a five-year, NCI-funded randomized controlled intervention trial (RCT) at Duke University Medical Center (Quit Smoking Program for Lung Cancer Patient s Families or Family Ties ; Duke IRB# 4620, Bastian, PI). Relatives who agree to participate will be asked to log on to a password protected website and view two online educational sessions and complete three online surveys. As part of the educational session, participants will be offered free genetic susceptibility testing for glutathione S transferase (GSTM1). Participants who accept testing will receive their result online. Participants who decline testing will be retained in the study and offered all the same smoking cessation services provided to those who accept testing. Participants will be sent instructions to collect their own buccal samples and postage-paid mailing envelopes to return the sample to a CLIA-approved laboratory at Duke. Survey assessments will include questions about risk perceptions, beliefs and attitudes related to lung cancer, emotional responses to the patient s diagnosis, smoking history, motivation to quit, reactions to information about smoking and genetic risk, interest in genetic testing, comprehension of susceptibility feedback, and interest in receiving smoking cessation services. The primary outcome variable will be seeking of free quit smoking services. Participating relatives will be surveyed by telephone via the Duke RCT infrastructure 6-months after completing the online protocol.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    507 participants
    Time Perspective:
    Prospective
    Official Title:
    Impact of a Patient's Lung Cancer Diagnosis on Relatives' Understanding of Genetic Risk Information and Receptivity to Quit Smoking
    Study Start Date :
    Dec 18, 2012
    Actual Primary Completion Date :
    Nov 25, 2013
    Actual Study Completion Date :
    Feb 25, 2016

    Outcome Measures

    Primary Outcome Measures

    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

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Moffitt Cancer Center Tampa Florida United States 33647
    2 Duke University Medical Center Durham North Carolina United States 27710

    Sponsors and Collaborators

    • National Human Genome Research Institute (NHGRI)

    Investigators

    • Principal Investigator: Laura M. Koehly, Ph.D., National Human Genome Research Institute (NHGRI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Human Genome Research Institute (NHGRI)
    ClinicalTrials.gov Identifier:
    NCT01862770
    Other Study ID Numbers:
    • 999913050
    • 13-HG-N050
    First Posted:
    May 24, 2013
    Last Update Posted:
    Apr 5, 2018
    Last Verified:
    Feb 25, 2016
    Keywords provided by National Human Genome Research Institute (NHGRI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 5, 2018