Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341341
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Impact of Lung Cancer Diagnosis on Relatives Understanding of Genetic Risk and Receptivity to Quit Smoking
Sponsor:
National Human Genome Research Institute NHGRI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Impact of a Patients Lung Cancer Diagnosis on Relatives Understanding of Genetic Risk Information and Receptivity to Quit Smoking
Status:
COMPLETED
Status Verified Date:
2010-07-16
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 GUMCLCCC 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 relatives 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
Healthy adult smokers between 18 and 55 years of age who are first or second degree relatives eg 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 GUMCLCCC 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 relatives 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
Detailed Description:
The overarching objective of this observational prospective Genetic Risk Lung Cancer Study is to evaluate the impact of a loved ones lung cancer diagnosis on relatives 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 and the Lombardi Comprehensive Cancer Center at the Georgetown University Medical Center GUMCLCCC First- or second-degree blood relatives who are current smokers between the ages of 18 to 55 will be eligible for the study Because these relatives will be living throughout the United Sates 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 The overarching objective of this observational prospective Genetic Risk Lung Cancer Study is to evaluate the impact of a loved ones lung cancer diagnosis on relatives seeking and processing of information related to risk 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 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 wil 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 Patients 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 geneticsusceptibility testing for glutathione S transferase GSTM1 Participants who accept testing will receive their result online Participants who decline testing will be retained in the 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-HG-N054 | None | None | None |