FREQUENTLY ASKED QUESTIONS
The purpose of this study is to identify why African American men have higher risk of prostate cancer and more aggressive forms of the disease. The study will focus on a wide range of potential factors (e.g. genetic, lifestyle, social, medical care-related).
Your participation will help future generations of African American men. We hope to learn how to better develop treatments and strategies to reduce the prostate cancer burden for African American men. You can also receive up to $50 for your time and effort.
No. This is not a clinical study and does not require you to see a doctor or have any medical tests performed. You will be asked to complete a questionnaire and provide a saliva sample.
We received your name from the cancer registry in the state where you were diagnosed. Each state is required by law to report the names of patients who are diagnosed with cancer. We did not obtain your name from your health care provider. Information on individuals with cancer can only be released for research purposes to qualified researchers who have obtained approval for the study.
We take confidentiality of information very seriously. All of the data and information that you will provide for this study will be kept confidential and will only be used for research purposes. All of the information about yourself as well as your genetic information will be kept in password protected files on secure computer servers. This study is overseen by the Institutional Review Boards (IRBs) that ensures we maintain strict confidentiality of the data in this study. Results from this research project may be published in scientific journals but your identity will not be released. All members of the research team have also signed a confidentiality document regarding the importance of data privacy. RESPOND researchers have many years of experience in protecting patient confidentiality in cancer research.
Participation is open to African American (or Black) men who were first diagnosed with prostate cancer in the United States on January 1, 2010 or later.
We expect that at least 10,000 African American men with prostate cancer will participate from across the United States. Active recruitment through the Cancer Registries will take place in the states of California, Texas, Louisiana, Florida, Georgia, and New Jersey, as well as from the Detroit metropolitan area. However, men from other states can volunteer to participate through our website (RESPONDstudy.org).
Participation involves completing a survey. This survey includes questions about your family, health history, neighborhood, community, life experiences, prostate cancer treatment, health behaviors and lifestyle. Participation also may include providing a saliva sample, and allowing us to obtain a small piece of tissue from your prostate biopsy or prostate surgery that your doctor already collected as part of your treatment or care.
There is no cost to you to participate in the study.
Yes. You could receive up to $80 for your time and effort. You will receive $30 for completing the survey, $30 for providing the saliva sample and another $20 for providing HIPAA authorization for obtaining your tumor sample.
No. You do not have to agree to all components of the study. Your participation in the study can just be limited to the survey, or survey and saliva kit, or survey and HIPAA authorization. However, we encourage you to participate in all components of the study (survey, saliva, and HIPAA authorization) as it will give a more comprehensive picture of the causes behind prostate cancer.
The survey will take about 30 to 60 minutes to complete. Providing a saliva sample will take 5-10 minutes. Reading and signing the informed consent form and HIPAA form will take 10-15 minutes.
People often believe that cancer is caused by poor health habits or “bad genes”. However, researchers are beginning to understand that living conditions and difficult life experiences can also impact health. On the survey we have included some sensitive questions about crime, neighborhood safety, discrimination, trust in the medical care system, and adverse childhood experiences. The childhood experience questions are standard questions used to assess one's lifetime exposure to stressful experiences such as physical, verbal, and sexual abuse as well as exposure to people who used drugs, abused alcohol, or were incarcerated. This information will allow us to identify whether early life adversity may affect health later in life.
Saliva has cells from your mouth from which your DNA can be isolated. DNA is your genetic code and is a blueprint of who you are. By studying your DNA we may be able to understand why some men have a greater risk of developing prostate cancer.
We use methods called 'DNA sequencing' and 'DNA genotyping' to determine the order of the genetic code. These laboratory methods allow researchers to study changes in your DNA code which may be related to one's risk of developing prostate cancer.
Your saliva, tumor and DNA sample will be stored for use in future research studies. It is important to store these samples as new technologies may be developed that will allow researchers to investigate new important questions about what causes prostate cancer.
The National Institutes of Health has a large research repository called the Database of Genotypes and Phenotypes (dbGaP) which allows for broad-sharing of genetic data with qualified investigators. Your genetic information may be sent to this repository for research purposes only. Your name and other information that could identify you will never be put into this scientific database. This is a controlled database that is only available to researchers who have been approved to view and use the data. All researchers who would like to access these genetic data must have research plans approved by their institution and a review board before they can access the data. Your genetic information will not be linked or shared with any federal or state DNA data base that may be used for criminal investigations.
In this study, your DNA results will be identified only by a random study ID number. Nobody will be able to know just from looking at the DNA results that it would belong to you. The only way someone could identify you is if they were able to get another sample from you, and do many genetic tests on that sample and then compare the genetic information from those tests with the information in the database. If a relative thought your information might be in the database, they could compare their own DNA, which is similar to yours, with the information in the database and may be able to trace the information back to you or at least to your family. However, the controlled database will only provide information to qualified researchers with an approved protocol and not to anyone else.
Yes. We plan to keep men informed about the results from the research study through newsletters as well as on the respond website (RESPONDstudy.org).
Yes. If you would like to speak with someone about the recruitment process and materials please contact us through the RESPOND study email (RespondStudy@med.usc.edu).
There are instructions included in the mailing that we send to you that describes the saliva collection process using the kit. We ask that you spit into the tube, and fill the tube up to the line with saliva, not counting the "bubbles." It can take a few “spits” and a few minutes to fill. After you have filled the tube, you can throw away the funnel top. Then please place the tube in the provided mailer, and send it back to us. If you have any questions about this process, please contact us at RespondStudy@med.usc.edu.
HIPAA stands for 'Health Insurance Portability and Accountability Act'. This Act protects your health information by law. You must sign this form to give us permission to request a small piece of tissue that was stored after you had your surgery (including your prostate biopsy and prostatectomy if relevant). This HIPAA form is required by the hospitals to provide us with access to your stored prostate tissue.
Yes. If for any reason you decide to withdraw from the study, you may request that your data and samples stored by study investigators be destroyed. If you would like to withdraw from this study, you can contact Christopher Haiman, ScD at 323-442-7755, Christopher.Haiman@med.usc.edu, or through our website (www.RESPONDStudy.org). If you withdraw, your DNA and tumor sample will be destroyed and your data will not be used in the future.
The RESPOND study is supported by the National Institutes of Health (NIH). The University of Southern California in Los Angeles was awarded a grant (# CA214253) from the NIH through the National Cancer Institute and the National Institute on Minority Health and Health Disparities of the National Institutes of Health. Additional funding for RESPOND is provided by the Prostate Cancer Foundation (PCF). NIH is providing 96% of the total funding ($25.5 million) and PCF is providing 4% of the funding ($1 million).
RESPOND stands for Research on Prostate Cancer in African American Men: Defining the Roles of Genetics, Tumor Markers, and Social Stress.
The RESPOND investigators include prostate cancer researchers and physicians from 11 institutions in the United States. Meet the RESPOND researcher team here.