Effect of Lung Cancer Diagnoses on Family Behaviors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
ClinicalTrials.gov Identifier:
NCT01862770
First received: May 23, 2013
Last updated: October 8, 2014
Last verified: November 2013
  Purpose

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
Lung Cancer
Blood Relatives of Patient w/Lung Cancer
Cigarette Smokers

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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. [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: December 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01862770

Locations
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33647
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Investigators
Principal Investigator: Laura M. Koehly, Ph.D. National Human Genome Research Institute (NHGRI)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
ClinicalTrials.gov Identifier: NCT01862770     History of Changes
Other Study ID Numbers: 999913050, 13-HG-N050
Study First Received: May 23, 2013
Last Updated: October 8, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Lung Cancer
Smokers
Genetic Risk Communication
Smoking Cessation

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 16, 2014