African American Families and Lung Cancer Study
|First Received Date ICMJE||June 16, 2007|
|Last Updated Date||September 26, 2015|
|Start Date ICMJE||June 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00487760 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||African American Families and Lung Cancer Study|
|Official Title ICMJE||African American Families and Lung Cancer Study|
This study will learn more about the beliefs of family members of African American patients with lung cancer and whether these beliefs are associated with their interest in genetic testing for disease risk and willingness to participate in genetics research. Lung cancer is the second most common form of cancer and the leading cause of cancer deaths for men and women in the United States. Like most cancers, there are racial and ethnic disparities (gaps) in lung cancer cases and deaths. The age-adjusted rates for blacks and whites (years 2000 to 2003) was 76.9 per 100,000 and 66.0 per 100,000, respectively. Mortality rates were 62.5 per 100,000 for blacks and 55.3 per 100,000 for whites. Cigarette smoking is the most preventable cause of lung cancer. Findings are that African Americans begin smoking at older ages and smoke fewer cigarettes per day than Caucasian Americans do. Yet the severity of lung cancer is greater for African Americans. Behavioral, social, environmental, and genetic factors may explain the differences.
Participants (subjects) ages 18 to 55 who are family of patients with lung cancer who self-identify as African Americans may be eligible for this study. Washington, D.C., researchers plan to recruit 115 lung cancer patients and 200 family members-100 current smokers and 100 who never smoked. Lung cancer patients, who must have been born in the United States, will be recruited from those who are receiving care at the Washington Cancer Institute at the Washington Hospital Center. They will be asked to list relatives and friends they consider to be as close as family. Patients will be asked permission for researchers to contact those people. Family members will receive a letter telling them that unless they decline to participate, they will be contacted by a telephone interviewer.
The survey will feature questions to evaluate family members' explanations for the causes of lung cancer, as well as their reactions to possible reasons for the disparity in lung cancer between African Americans and Caucasian Americans. Subjects will be asked about perceived personal risk, worry about developing lung cancer, smoking history, motivation to quit smoking, feelings about the lung cancer patient's diagnosis, racial identify, experience with racial discrimination, pros and cons of genetic testing, and interest in genetic testing. The survey will take up to 20 minutes to complete.
This study may or may not have a direct benefit for those who participate. However, lung cancer patients and their families will be offered a free self-help guide to stop smoking. They will be referred to local smoking cessation programs. Knowledge gained from the study may be used to design smoking cessation methods and research studies related to genetics for minority populations.
|Detailed Description||The purpose of the African American (AA) Families and Lung Cancer Study is to learn more about (1) the beliefs of family members of AA patients with lung cancer about why AA get lung cancer and (2) whether these beliefs are associated with their interest in genetic testing for lung cancer risk and willingness to participate in clinical genetics research. We plan to recruit 200 AAs (n = 100 current smokers and n = 100 never smokers) who are considered to be as close as family (both biological and non-biological kin) to patients with lung cancer who self-identify as AA (n = 115). Patients will be recruited from Washington Cancer Institute at the Washington Hospital Center in Washington, DC. Family members who self-identify as AA and are between the ages 18 and 55 will be eligible for the study. A Washington Hospital Center recruiter will approach patients and ask their willingness to be contacted for a telephone survey about their general well-being. As part of the survey, patients will be asked to enumerate family and friends who they consider to be as close as family, and asked to specifically focus on those who are current cigarette smokers and those who have never smoked. Patients will be asked to give permission to contact some or all of those enumerated. These family members will be mailed a letter to inform them that unless they call to decline they will be contacted by a telephone interviewer. The survey will include questions to assess family members' explanations for the causes of lung cancer and reactions to possible explanations for disparities in lung cancer between AA and Caucasian Americans (CA), perceived personal risk and worry about developing lung cancer, smoking history, motivation to quit smoking, emotional responses to the patient's diagnosis, racial identity, experience with racial discrimination, pros and cons of genetic testing, and interest in genetic testing (the primary outcome variable). Data analysis using hierarchical linear modeling will assess whether patient characteristics and family members' endorsement of genetics as the cause of lung cancer are associated with their interest in genetic testing and participation in clinical genetics research.|
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Lung Cancer|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||400|
|Estimated Completion Date||August 2011|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
In order to be included in this study, patients with lung cancer must meet inclusion criteria at 2 steps: (1) initial screening and written consent to be contacted by telephone, and (2) provision of verbal consent at the time of telephone contact to complete the survey.
Step 1a: In order to be approached about the study, patients must be (1) at least 18 years of age, (2) diagnosed with lung cancer at any stage (Stages Ia-IV), (3) approved for contact by their oncologist, and (4) identified by the recruiter or identified in medical records as Black.
Step 1b: In order to provide consent for contact for the telephone survey, patients must self-identify as AA/Black and must have been born in the U.S. Also, patients must be willing to give permission to contact at least one family member or friend considered as close as family who is a current cigarette smoker between the ages of 18 and 55 in order to provide consent.
Step 2: At the point of the patient survey, all patients will be asked their race/ethnicity. All patients who self-identify as AA/Black as defined by this research will be administered the patient survey.
Family members must self-identify as AA and be between the ages of 18 and 55 to be eligible for the study. Family also must meet the following inclusion criteria to be classified as either a current smoker (defined below) or a never smoker (defined below). These criteria for current smoker and never smoker are based on standard criteria used in smoking research.
Current Smoker: to be included as a smoker , the family member must report having smoked at least 100 cigarettes in their lifetime, and smoked 7 or more cigarettes in the past 7 days at the time of the family member survey.
Never Smokers: to be included as a never smoker , a family member must report no to having smoked at least 100 cigarettes in their lifetime.
Former smokers (i.e., family who have smoked at least 100 cigarettes in their lifetime but smoked fewer than 7 cigarettes in the past 7 days) because previous research shows consistently that these individuals hold attitudes and beliefs more similar to those of current smokers than never smokers.
Patients who describe themselves as AA or Black but were not born in the U.S. will be excluded from participation.
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00487760|
|Other Study ID Numbers ICMJE||999907161, 07-HG-N161|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Human Genome Research Institute (NHGRI)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP