What is the purpose of CPS-3?

The goal of CPS-3 is to better understand the factors (lifestyle, environmental, genetic) that cause or prevent cancer and, ultimately, to help eliminate cancer as a major health concern for future generations.

What does study participation involve?

Enrollment is a simple, two-phase process. One phase takes place at home and the other takes place on-site at an enrollment opportunity in select communities. On-site you will be asked to: read and sign an informed consent, complete a brief written survey, provide a waist measurement, and give a small blood sample (similar to a doctor’s visit) drawn by a trained, certified phlebotomist. At home you will complete a more detailed survey. This survey will ask for information on your lifestyle, behavioral, and other factors related to your health. We will continue to mail follow-up surveys periodically.

Who is running the study?

CPS-3 is funded and managed by the American Cancer Society Department of Epidemiology & Surveillance Research (Analytic Epidemiology program). The Analytic Epidemiology program conducts, analyzes, and publishes original research on the causes and prevention of cancer utilizing these large follow-up studies.

How long will the study last?

Participants will be followed for at least 20 years. This means that once you are enrolled we will be contacting you every two years with mailed questionnaires for you to answer. While you may be in the study for many years, we expect the amount of time it will take you to answer a questionnaire to be minimal (about 45 minutes for the follow-up questionnaires).

Who can enroll?

Men and women between the ages of 30 and 65 who have never been personally diagnosed with cancer and are willing to make a long-term commitment to the study.

Why is there an age range from 30-65?

An important part of maintaining the scientific validity of this study is being able to follow individuals over time. Generally young adults in their 20’s tend to be more transient and it becomes more difficult to follow these individuals. For individuals over the age of 65, much of the relevant time period for exposures of interest (such as during early and middle adult years) has to be recalled and remembering events, behaviors, or other lifestyle information from many years ago with accuracy can be more difficult. For these reasons, we are looking for individuals between ages 30 adn 65 and will follow them while collecting relevant lifestyle, behavioral, and medical information moving into the future.

Why not study individuals who have had cancer?

Since the goal of CPS-3 is to better understand ways to prevent cancer, it is important to begin with a population who is cancer free. Once a person has cancer, the body has been affected by the disease, treatment, and/or lifestyle changes. For this reason it is difficult to collect certain kinds of information and study how to prevent the disease. Additionally, various factors in their blood may be altered due to their treatment. Enrolling individuals without a personal history of cancer to enroll will enable us to study how to prevent the disease.

Why do you need people to be willing to make a long-term commitment to CPS-3?

There are two equally important pieces to building a study like CPS-3. The first, and more obvious piece, is getting 500,000 individuals to enroll into the study. The second piece is to keep these individuals in your study over a long period of time. Large-scale studies like CPS-3 are scientifically valid only if you can successfully track and “follow” your participants over time. So, maintaining contact with participants is critical. This is the main reason we are going to Relay events to recruit our study participants because we need individuals who not only meet the eligibility criteria, but also are willing and able to make the long-term commitment to the study.

Why is the goal to enroll at least 25% minority (racial and ethnic) representation?

To determine whether risk factors for cancer are different across various racial/ethnic groups, we need to enroll men and women across a wide range of racial/ethnic groups as well as across a range of ages.

Will every state have CPS-3 enrollment available?

While we will be enrolling in every division of the American Cancer Society within the next five years, we will not enroll in every state in the US. This decision was based on various factors including quality of state cancer registries, population density, and proximity of the study laboratory partner facilities. The states that will be participating are: AL, AZ, CA, CO, CT, FL, GA, IL, IN, LA, MD, MA, MI, MN, MO, NM, NJ, NY, NC, OH, PA, SC, TX, WA, WI, as well as D.C. and Puerto Rico. Since you do not have to be a registered Relay For Life participant to enroll, you may attend a nearby Relay event and become a participant. The CPS-3 website,www.cancer.org/cps3 will post the most up-to-date enrollment dates and locations.

Will translated materials be available?

Study materials will be translated to Spanish only.

Do I have to live in the U.S. to be eligible?

Due to the difficulity in following individuals for the length of the study, individuals must live in one of the following countries or territories to be eligible for enrollment: United States, Puerto Rico, and Guam.

Who makes sure this study is safe and scientifically sound?

There will be ongoing peer review of CPS-3 by cancer researchers from many prominent university and research institutions. Review and oversight by the Emory University IRB (Institutional Review Board) continues throughout the study. When a study has completed active enrollment, the IRB continues to provide oversight while investigators analyze questionnaire and biological data.

What is an Institutional Review Board?

An Institutional Review Board (IRB) is a research oversight committee charged with assuring, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in approved research studies based on the ethical principles of the Belmont Report.

What is the Belmont Report?

In 1974 Congress passed the National Research Act which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission wrote the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (commonly referred to as the Belmont Report). The Belmont Report contains the ethical principles upon which the federal regulations for protection of human subjects are based.

How is Cancer Prevention Study-3 different from the Tuskegee Experiment (aka Tuskegee Syphilis Study)?

The Tuskegee Experiment was a clinical study, conducted between 1932 and 1972 in which 399 poor and mostly illiterate African American sharecroppers were studied to observe the natural progression of syphilis if left untreated. Individuals in that study were not informed that they had syphilis, and treatment was withheld. Cancer Prevention Study-3 is not a clinical study, nor are we providing (or withholding) treatment for cancer or other diseases. Blood samples of individuals enrolled in CPS-3 are to study what causes cancer and how to prevent it.

In addition, individuals in the Tuskegee Syphilis Study were not given the opportunity to provide informed consent. As a result of the Tuskegee Experiment, the 1979 Belmont Report, the establishment of the National Human Investigation Board, and the requirement for Institutional Review Board approval for any study involving human subjects was mandated. Cancer Prevention Study-3 and all research studies started after 1979 must conform to the guidelines set forth by the Belmont Report, and are subject to extensive review and approval by the Institutional Review Board, and all individuals who participate in Cancer Prevention Study-3 must provide written informed consent.

How will you use all of my information?

We begin the study by collecting information on various exposures from individuals who do not have cancer and we continue to update this information over time. As cases of cancer or other diseases develop, we will compare those participants who develop cancer with those participants who do not. By doing so, we are able to understand the differences (in lifestyle, environment, and genetic factors) between people who get cancer and those who do not, what the likely risk factors are for cancer, and how to best prevent disease in the future.

Will I ever have to provide medical records?

If you are diagnosed with cancer while you are still participating in CPS-3, we will ask you for written permission to seek more information about your diagnosis and treatment from your doctor and from your medical record. At that time, you can agree to give us permission or not. Since risk factors for cancer may differ by various pathologic characteristics (like tumor location, tissue type, etc.) the best source for accurate information on specific tumor features is the medical record.

Will my information be kept confidential? How will this be done?

Yes. Every effort will be made to protect the identity of the participants in this study. All of the study staff sign confidentiality forms and undergo training in research ethics. When your data are collected, they are labeled with a unique identification number. After your data are collected, your blood samples, questionnaires, and other study materials are stored separately from all personal identifiers, such as your name, address, phone number, and social security number. All study materials will be stored in a locked facility and secured computer files, and your personal contact information will be kept in separate files accessible only to a limited number of CPS staff. This information will not be shared with anyone, including other staff at the American Cancer Society, unless they are directly involved in managing CPS-3.

Why do I have to provide my social security number?

We understand that social security numbers are private and many individuals are worried about sharing this information. However, social security numbers are very important in long-term follow-up studies like CPS-3. We use them to link with cancer registries and death certificates, to learn who in the study has developed cancer or who has died. We will never willingly share this number with anyone and only key study personnel will have access to use it for purposes related directly to CPS-3. These personnel are part of the scientific research team and understand the importance of protecting your privacy.

Why is a waist measurement required?

Many conditions, such as insulin resistance, diabetes, and other metabolic conditions, are highly related to waist circumference. Many of these conditions are also related to the development of cancer. Thus, getting this simple waist measurement will provide very important information to researchers in the future.

What if I don’t want to give a waist measurement, can I still be in the study?

Providing your waist measurement is part of the enrollment process. The more complete the data you provide us about yourself, the more valuable our research resource becomes.

Why am I completing a menstrual postcard (women)?

Hormone levels are strongly related to the development of many types of cancer in women (such as breast, endometrial, and ovarian cancer). A woman's hormone levels vary greatly during the monthly course of her menstrual cycle (or period). For this reason, it is critical for us to understand where in the monthly menstrual cycle a woman is when she provides her blood sample. We obtain the first date of the last period (on the enrollment survey) and also the first day of the subsequent period (through the postcard) so that we can pinpoint the exact date of your cycle when blood is drawn. This postcard will be mailed to each participant so that you can indicate when your next cycle begins and return it to the Epidemiology Department.

What if I no longer have my periods? Do I still have to complete the postcard (women only)?

No, if you no longer have your menstrual periods, you do not have to complete your mailing address on the postcard.

Why is a blood sample required?

We need a blood sample to measure things such as hormones, nutrients, vitamins, chemicals, metals, and genetic factors that may be related to your risk of developing cancer. Questionnaire data provide a detailed picture of your lifestyle and environment, but the most accurate picture of your actual exposures or susceptibility to disease may come from what we can measure in your blood. It is important that we collect this sample when you first enroll in the study so that a new health problem does not alter the levels of anything we measure.

What if I don’t want to give a blood sample, can I still be in the study?

Providing a blood specimen is part of the enrollment process. The more complete the data you provide us about yourself, the more valuable our research resource becomes. Without your blood sample, we are unable to examine any blood or genetic measures in relation to cancer risk.

Why don’t you do all of the blood tests at the start of the study? Why do you need to store my blood?

At the start of the study, we do not know who may develop cancer. As cancer cases occur, we will study measures in the blood that may be important in cancer development. We would also like to take advantage of advances in science and technology as well as explore potentially new hypotheses in the future and having blood samples stored will allow us to do the tests that are most likely to give us new information about cancer development.

Phlebotomists often times have difficulty drawing my blood, will I be dropped from the study if they can’t get my blood?

No. Per our scientific protocol, trained phlebotomists will make two attempts to withdraw blood from a study participant after which they will stop trying. If the phlebotomist is unable to draw blood, you still will be enrolled in the study.

Is there any risk involved with this type of blood collection?

There is limited risk with this type of collection. Collecting blood from a vein in someone’s arm is a standard medical procedure; however, there is a small risk of some discomfort or bruising at the spot where blood is withdrawn.

Will I be notified of any results from tests done on my blood?

No. By enrolling in CPS-3, you are donating your blood sample for research purposes. You will not be informed of any of the results of any tests that may be performed using your blood sample. Reasons for not sharing individual results include: testing is not performed in certified clinical labs, and testing is not intended to be used as a diagnostic test or to make decisions about your medical care. Although, we will not be able to provide you with your individual test results, we will share results from our overall analyses with all study participants through newsletters, e-mail, articles on our website or other means.

Why would I want to participate in this research study?

Most people who participate in research studies hope they will contribute to a better understanding of how to prevent disease. For CPS-3, this knowledge will help reduce the burden of cancer for this and future generations.

Will it cost me anything to participate in the study?

There are no costs to you other than your time for participating in the study. Costs for the blood draw, survey materials, and postage will be paid by the American Cancer Society.

Will I get paid to participate in the study?

You will not receive any direct payment from participating in this study. However, by taking part, you will help us learn more about the causes of cancer and other diseases, and perhaps find ways to prevent cancer in the future.

Can I still be in the study if I develop cancer

Yes. As cases of cancer or other diseases develop, we will compare those participants who develop cancer with those participants who do not. By doing so, we are able to understand the differences (in lifestyle, environment, and genetic factors) between people who get cancer and those who do not, what the likely risk factors are for cancer, and how to best prevent disease in the future. We also want to learn if environmental, lifestyle, and genetic factors influence treatment outcomes, survival, and quality of life following a cancer diagnosis. It will be important for us to follow all participants, including those who develop cancer, for the full length of the study.

How do I enroll in CPS-3?

Enrollment in CPS-3 will be conducted at Relay For Life events across the nation.

Can I enroll if I am not a Relay For Life participant (If enrolling at a Relay for Life event)?

Yes. You do not have to be a registered Relay participant to enroll in CPS-3. You simply have to meet eligibility requirements and be willing to make the commitment to the study.

How do I find the closest Relay that is enrolling?

See the section Locations of CPS-3 Enrollment or email cps3@cancer.org.

Will all Relays enroll?

No. We will select Relays that are large or offer potential for minority recruitment. Not all Relay sites will have CPS-3 enrollment. Ideally Relays will have at least 1,000 registered team members to be included as an enrollment site. If your site is not selected, see the section Locations of CPS-3 Enrollment or email cps3@cancer.org.

Can I sign up outside of a Relay or prior to the Relay?

Relay is the only venue for enrollment. If you cannot participate in your Relay, visit the CPS-3 website to find another Relay near you where you might enroll in CPS-3.

What happens if I move or change my phone number or email address while I’m in the study?

We want you to let us know about changes in your contact information as soon as possible. You can call us toll free at 1-888-604-5888 or email us at cps3@cancer.org to report any changes. We also will give you the opportunity to provide new contact information every time we mail a follow-up questionnaire.

How will I get results of the study?

It is important to us that you learn results from CPS-3 as soon as possible. We will send you annual newsletters with highlights of study results. CPS-3 results also will be published in scientific journals, and we will post these on the American Cancer Society website (www.cancer.org), and provide links to the articles.

Where can I find out more about risk factors, diagnosis, and treatment for cancer?

You can contact the American Cancer Society by calling 1-800-ACS-2345 or by visiting the American Cancer Society website at www.cancer.org. Cancer information specialists are available 24-hours a day 365-days a year to answer questions about diagnosis, treatment, statistics, financial assistance, and support programs. Spanish services are available.