Lung CancerNCT01862770
Effect of Lung Cancer Diagnoses on Family Behaviors
An observational study of Lung Cancer and Blood Relatives of Patient w/Lung Cancer, run by National Human Genome Research Institute (NHGRI) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Lung Cancer, Blood Relatives of Patient w/Lung Cancer, Cigarette Smokers
- How many people
- 507 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Dec 2012to 25 Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
Moffitt Cancer Center
Tampa, Florida, 33647
About this study
Official title: Impact of a Patient's Lung Cancer Diagnosis on Relatives' Understanding of Genetic Risk Information and Receptivity to Quit Smoking
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.
Read more
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.
Read the 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.
- Keywords
- Lung Cancer, Smokers, Genetic Risk Communication, Smoking Cessation
- Medical subject headings
- Lung Neoplasms, Smoking Cessation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study start18 Dec 2012
- Primary completion25 Nov 2013
- Study completion25 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 507 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Laura M. Koehly, Ph.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862770
- Sponsor's protocol ID
- 999913050
- Other IDs
- 13-HG-N050
- Status last verified
- 25 Feb 2016
- First submitted
- 23 May 2013
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
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.
PubMed 15184245Aspinwall 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.
PubMed 8505703Belogubova 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.
PubMed 15165083
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Patient's Lung Cancer Diagnosis on Relatives' Understanding of Genetic Risk Information and Receptivity to Quit Smoking
- ClinicalTrials.gov ID
- NCT01862770
- Acronym / sponsor ID
- 999913050
- Keywords
- Lung Cancer, Smokers, Genetic Risk Communication, Smoking Cessation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 507 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 18 Dec 2012
- Primary completion
- 25 Nov 2013 (actual)
- Study completion
- 25 Feb 2016 (actual)
- First posted
- 24 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 15184245Alexandrie 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.
- Background: PubMed 8505703Aspinwall 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.
- Background: PubMed 15165083Belogubova 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura M. Koehly, Ph.D. principal investigator
National Human Genome Research Institute (NHGRI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Blood Relatives of Patient w/Lung Cancer, run by National Human Genome Research Institute (NHGRI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01862770, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.