Lung CancerNCT00487760
African American Families and Lung Cancer Study
An observational study of Lung Cancer, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2007to 2 Aug 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients:
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this 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.
Read more
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.
Read the 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.
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, African-American Families, Genetic Risk Communication, Interest in Genetic Testing and Genetics Research, Health Disparities, Smoking Cessation
- Medical subject headings
- Lung Neoplasms, Smoking Cessation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2007 (estimated)
- Study start11 Jun 2007
- Study completion2 Aug 2011
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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487760
- Sponsor's protocol ID
- 999907161
- Other IDs
- 07-HG-N161
- Status last verified
- 2 Aug 2011
- First submitted
- 16 Jun 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Arthur CM, Katkin ES. Making a case for the examination of ethnicity of Blacks in United States Health Research. J Health Care Poor Underserved. 2006 Feb;17(1):25-36. doi: 10.1353/hpu.2006.0017.
PubMed 16520504Baty BJ, Kinney AY, Ellis SM. Developing culturally sensitive cancer genetics communication aids for African Americans. Am J Med Genet A. 2003 Apr 15;118A(2):146-55. doi: 10.1002/ajmg.a.10150.
PubMed 12655495Clark R, Anderson NB, Clark VR, Williams DR. Racism as a stressor for African Americans. A biopsychosocial model. Am Psychol. 1999 Oct;54(10):805-16. doi: 10.1037//0003-066x.54.10.805.
PubMed 10540593
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- African American Families and Lung Cancer Study
- ClinicalTrials.gov ID
- NCT00487760
- Acronym / sponsor ID
- 999907161
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, African-American Families, Genetic Risk Communication, Interest in Genetic Testing and Genetics Research, Health Disparities, Smoking Cessation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 11 Jun 2007
- Study completion
- 2 Aug 2011
- First posted
- 19 Jun 2007 (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.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 16520504Arthur CM, Katkin ES. Making a case for the examination of ethnicity of Blacks in United States Health Research. J Health Care Poor Underserved. 2006 Feb;17(1):25-36. doi: 10.1353/hpu.2006.0017.
- Background: PubMed 12655495Baty BJ, Kinney AY, Ellis SM. Developing culturally sensitive cancer genetics communication aids for African Americans. Am J Med Genet A. 2003 Apr 15;118A(2):146-55. doi: 10.1002/ajmg.a.10150.
- Background: PubMed 10540593Clark R, Anderson NB, Clark VR, Williams DR. Racism as a stressor for African Americans. A biopsychosocial model. Am Psychol. 1999 Oct;54(10):805-16. doi: 10.1037//0003-066x.54.10.805.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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, run by National Human Genome Research Institute (NHGRI) at 1 site 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?
The sponsor lists 9 inclusion and 2 exclusion criteria. 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00487760, 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 2 Jul 2017.