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

30. Juni 2017 aktualisiert von: National Human Genome Research Institute (NHGRI)

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

757

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Maryland
      • Bethesda, Maryland, Vereinigte Staaten, 20892
        • National Human Genome Research Institute (NHGRI), 9000 Rockville Pike

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 55 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

  • 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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

7. Dezember 2004

Studienabschluss

16. Juli 2010

Studienanmeldedaten

Zuerst eingereicht

19. Juni 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Juni 2006

Zuerst gepostet (Schätzen)

21. Juni 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juli 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Juni 2017

Zuletzt verifiziert

16. Juli 2010

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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