The National Cancer Institute (NCI) has updated its cancer information delivery services. In the future, please use the Cancer.gov web site (Http: //cancer.gov/) to meet your cancer information needs. CancerMail users in the United States can obtain cancer information by telephone at 1-800-4-CANCER (1-800-422-6237).

The NCI will no longer support CancerMail after November 2002. If you have comments about the NCI's cancer information delivery services, contact us by e-mail at cancer.govstaff@mail.nih.gov or call 301-496-9096.

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An interagency agreement between the Department of Defense (DoD) and the National Cancer Institute (NCI) gives TRICARE^1 beneficiaries more options for cancer care and greater access to the latest advances in cancer prevention (including screening and early detection) and treatment through clinical trials. Known as the DoD/NCI Cancer Clinical Trials Demonstration Project, this agreement was signed in June 1999. It represents the first time that a national health plan has agreed to provide coverage for patients to participate in cancer prevention trials.

The DoD/NCI clinical trials agreement allows cancer patients who are beneficiaries of TRICARE, the medical program of the DoD, to participate in phase II and phase III NCI-sponsored cancer prevention (including screening and early detection) and treatment clinical trials and have the associated medical costs reimbursed.

Phase II clinical trials provide preliminary information about the anticancer effects of drugs or prevention agents; phase III clinical trials compare promising new cancer treatments or prevention strategies with standard care. About 20,000 cancer patients enroll in NCI treatment clinical trials each year.

During a cancer clinical trial, patients are cared for in the same facilities where standard care is provided. These facilities include more than 2,000 sites throughout the United States, including military hospitals, clinics, cancer centers, community hospitals, and doctors offices. Costs for screening tests to determine clinical trial eligibility, and the associated costs of participation in cancer clinical trials are covered for qualified TRICARE members. Family members of active duty personnel, as well as TRICARE-eligible retired service members and their families, may participate in trials at military treatment facilities or in civilian health care settings. Active duty members may participate in NCI-sponsored clinical trials at military treatment facilities.

DoDs primary medical mission is to provide medical services and support to the Armed Forces during military operations, but DoD also offers health services during peacetime to members of the Armed Forces, their family members, and others entitled to DoD medical care. The DoD administers health benefits to about 8.3 million beneficiaries through its direct care system at military hospitals and clinics, as well as care purchased from civilian providers who are reimbursed by DoD.

1TRICARE provides medical coverage for active duty members, qualified family members, CHAMPUS-eligible retirees and their family members, and survivors of all uniformed service members.

Questions and Answers About the DoD/NCI Clinical Trials Agreement

1. What are clinical trials?

Clinical trials are research studies conducted with people to find better ways to prevent, detect, diagnose, and treat cancer. The DoD/NCI clinical trials agreement allows TRICARE beneficiaries to participate in NCI-sponsored phase II and phase III cancer prevention and treatment trials. Under this agreement, cancer prevention clinical trials will include not only studies designed to prevent cancer but also studies to screen for cancer and to find cancer in its early stages.

+ A phase II cancer prevention trial focuses on learning

whether the agent being studied (medicine, vitamin,
mineral, food supplement, or a combination of these) has
an effect on preventing a particular type of cancer. It may
also involve the use of cancer screening tests or evaluation
of a method to better detect a cancer.

+ A phase III cancer prevention trial compares promising new agents with a standard agent or a placebo (an inactive substance that looks the same as, and is administered in the same way as, a drug in a clinical trial). Some phase III trials evaluate cancer screening tests to see if they can decrease the cancer death rate.

+ A phase II cancer treatment trial usually focuses on a

particular type of cancer and provides preliminary
information on the anticancer effect of a new drug or
therapy.

+ A phase III cancer treatment trial compares a promising new treatment with standard treatment.

People who do not have cancer can take part in cancer prevention clinical trials to try to prevent the disease from occurring. Some people who have had cancer can participate in prevention trials to try to reduce the chance of either developing a new type of cancer or to prevent the cancer from recurring (coming back). Prevention clinical trials are important because through research, scientists hope to determine what steps are effective in preventing cancer or finding cancer early.

There are two kinds of cancer prevention clinical trials. Action studies (doing something) focus on finding out whether actions people take, such as exercising more or quitting smoking, can prevent cancer. Agent studies (taking something) focus on examining whether taking certain medicines, vitamins, minerals, or food supplements (or a combination of them) can prevent cancer.

5. Why participate in a cancer treatment clinical trial?

Patients take part in cancer treatment clinical trials in hopes for a cure, a longer time to live, or a way to feel better. Often, patients feel that taking part in clinical trials benefits others by improving future cancer treatment options. Many clinical trial participants may be the first to receive new treatments before they are widely available. No cancer patient goes without treatment or receives a placebo (inactive substance) when there is a standard cancer therapy available. Cancer treatment studies lead to advances in cancer treatment, which may become the future standard care.

6. Where do patients receive care?

When participating in a DoD/NCI clinical trial, patients are closely monitored and cared for in the same facilities where standard care is provided. These facilities include more than 2,000 sites throughout the United States, such as military hospitals, clinics, cancer centers, community hospitals, and doctors offices.

TRICARE beneficiaries, including retired service members and their families, and family members of active duty personnel are eligible. Medical care costs are covered when participating in both phase II and phase III NCI-sponsored clinical trials in civilian health care facilities and in military treatment facilities. Active duty members can participate in clinical trials at military treatment facilities.

8. What is covered?

Costs for screening tests to determine clinical trial eligibility, as well as the related costs of participating in the trial, are covered under this demonstration project. All usual TRICARE rules, cost shares, and deductibles apply, and eligible patients may receive care out of the TRICARE network. For more information, you may consult your health benefits advisor, or call the DoD cancer trials demonstration coordinator for your TRICARE region. For regions 6, 7, 8, 9, 10, 11, and 12, the telephone number is 18003957821. For all other regions, the telephone number is
18007793060.

Patients and providers can learn more about patient participation in the DoD/NCI clinical trials demonstration project through the resources listed below.

+ Over the phone: Call the NCIs Cancer Information Service (CIS) at 18004CANCER (18004226237), Monday through Friday, 9:00 a.m. to 4:30 p.m., local time. The CIS is a national information and education network that provides up-to-date cancer information to patients, their families, health professionals, and the general public. CIS information specialists have access to PDQ, NCIs comprehensive computer database of cancer information, and can share information from PDQ about clinical trials covered by the demonstration project. The CIS responds to calls in English and Spanish. Deaf and hard of hearing callers may use the toll-free TTY number at 18003328615.

Also, the DoD cancer trials demonstration project coordinator may be contacted at 18007793060 in regions 15, or at 18003957821 in regions 612. Patients and health care providers can call for more information about using and authorizing this benefit, or they may contact a case manager. Pre-authorization is required only when patients are treated in a clinical trial outside of a military treatment facility.

+ On the Internet: The NCI has many online resources to help you locate cancer clinical trials and cancer information. The NCIs Web site (Http: //cancer.gov) provides up-to-date PDQ cancer information summaries on prevention, screening, treatment, supportive care, and complementary and alternative medicine for many types of cancer. The clinical trials page of NCIs Web site (Http: //cancer.gov/clinical_trials/) provides the latest news in cancer research and general information about clinical trials. This page also has a feature that allows users to search for trials being conducted at VA hospitals/medical centers or other military treatment facilities (Http: //cancer.gov/search/clinical_trials/va_military/). TRICAREs guide to the cancer clinical trials demonstration project is available at Http: //www.tricare.osd.mil/cancertrials/ on the Internet.

+ CancerNet Search Service: Physicians and other health care providers can request customized PDQ and CANCERLIT searches and receive information by telephone, e-mail, or fax. The toll-free number for the CancerNet Search Service (in the United States) is 18003453300. Hours of operation are Monday through Friday, 8:00 a.m. to 5:00 p.m. Eastern time. Requests can also be faxed to 18003801575 (3018979563 outside the United States) or sent via e-mail to pdqsearch@cips.nci.nih.gov.

You may want more information for yourself, your family, and your doctor. The following National Cancer Institute (NCI) services are available to help you.

Telephone...

Cancer Information Service (CIS)

Provides accurate, up-to-date information on cancer to patients and their families, health professionals, and the general public. Information specialists translate the latest scientific information into understandable language and respond in English, Spanish, or on TTY equipment.

Toll-free: 1-800-4-CANCER (1-800-422-6237)
TTY: 1-800-332-8615

Http: //cancer.gov - Cancer.gov is the NCI s primary web site and provides immediate access to critical cancer information and resources. It contains material for health professionals, patients, and the public, including information from PDQ about cancer treatment, screening, prevention, genetics, supportive care, and clinical trials, and CANCERLIT, a bibliographic database. Cancer.gov also includes information on understanding trials, deciding whether to participate in trials, finding specific trials, plus research news and other resources.

E-mail...

CancerMail

Includes NCI information about cancer treatment, screening, prevention, genetics, and supportive care. To obtain a contents list, send e-mail to cancermail@cips.nci.nih.gov with the word "help" in the body of the message.

Fax...

CancerFax

Includes NCI information about cancer treatment, screening, prevention, genetics, and supportive care. To obtain a contents list, dial 301-402-5874 or 1-800-624-2511 from a touch-tone telephone or fax machine hand set and follow the recorded instructions.

Date Last Modified: 07/2002

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