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Impact of Lung Cancer Diagnosis on Relatives' Understanding of Genetic Risk and Receptivity to Quit Smoking

Impact of a Patient's Lung Cancer Diagnosis on Relatives' Understanding of Genetic Risk Information and Receptivity to Quit Smoking

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 (e.g., 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 GUMC/LCCC, 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 relative's 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

The overarching objective of this observational prospective "Genetic 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 and the Lombardi Comprehensive Cancer Center at the Georgetown University Medical Center (GUMC/LCCC). 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 one's lung cancer diagnosis on relative's 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 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 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 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.

Type d'étude

Observationnel

Inscription (Anticipé)

757

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Maryland
      • Bethesda, Maryland, États-Unis, 20892
        • National Human Genome Research Institute (NHGRI), 9000 Rockville Pike

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 55 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

  • INCLUSION CRITERIA:

The target sample for the study is 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.

Aside from age and blood relationship to the lung cancer patient, eligibility criteria also will include the following:

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);

Is English speaking.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

7 décembre 2004

Achèvement de l'étude

16 juillet 2010

Dates d'inscription aux études

Première soumission

19 juin 2006

Première soumission répondant aux critères de contrôle qualité

19 juin 2006

Première publication (Estimation)

21 juin 2006

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 juillet 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 juin 2017

Dernière vérification

16 juillet 2010

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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