An interagency agreement between the Department of Defense (DoD) and the National Cancer Institute (NCI) gives TRICARE* beneficiaries more options for cancer care and greater access to the latest advances in cancer prevention and treatment through clinical trials. The DoD has added the coverage of certain cancer clinical trials to the permanent health care benefits for TRICARE beneficiaries.

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 clinical trials (including screening and early detection) and treatment clinical trials and have the associated medical costs reimbursed. Phase II trials study the safety and effectiveness of an agent or intervention and evaluate how it affects the human body. Phase III trials compare a new agent or intervention (or new use of a standard one) with the current standard therapy. More than 25,000 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 TRICARE beneficiaries. 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.

DoD’s primary medical mission is to provide medical services and support to the Armed Forces during military operations. 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 9.2 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.

* TRICARE provides medical coverage for active duty members, their eligible family members, retirees and their eligible 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 diseases such as 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 (early detection).

2. What happens in phase II and phase III cancer prevention clinical trials?
   
   
   • 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.
     
     
3. What happens in phase II and phase III cancer treatment clinical trials?
   
   
   • 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 new treatment (or new use of a standard one) with the current standard treatment.
     
     
4. Why participate in a cancer prevention clinical trial?

   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. Cancer treatment studies lead to advances in cancer treatment, which may become the future standard care. 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.

6. Where do patients receive care?

   When participating in an NCI-sponsored 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.

7. Who is eligible to participate in the DoD/NCI clinical trials agreement?

   TRICARE beneficiaries, including retired service members and their eligible 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 cancer 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 cancer clinical trial eligibility, as well as the related costs of participating in the trial, are covered under TRICARE. All usual TRICARE rules, cost shares, and deductibles apply, and eligible patients may receive care out of the TRICARE network.

9. How can patients and health care providers learn more?

   Patients and providers can learn more about patient participation in NCI-sponsored clinical trials through the resources listed below.

   • Over the phone: The NCI's Cancer Information Service (CIS) provides personal, confidential help. The CIS is the source for the latest, most accurate cancer information for patients, their families, the general public, and health professionals. To talk with an information specialist, please call 1–800–4–CANCER (1–800–422–6237) Monday through Friday, 9:00 a.m. to 4:30 p.m., local time. For callers with TTY equipment, the number is 1–800–332–8615. CIS information specialists have access to PDQ®, NCI’s comprehensive cancer information database, and can share information from PDQ about NCI-sponsored clinical trials. The CIS responds to calls in English and Spanish.

     Also, the regional TRICARE contractor cancer trials coordinators may be contacted.

     The Palmetto Government Benefits Administrators (PGBA) are the point-of-contact for cancer trials for the TRICARE North and South Regions:
     Call 1–800–395–7821 for the North Region.
     Call 1–800–444–5445 for the South Region.

     TriWest is the point-of-contact for cancer trials for the TRICARE West Region:
     Call 1–866–427–6610 for the TRICARE West Region.

     Wisconsin Physicians Service (WPS) is the point-of-contact for cancer trials for TRICARE for Life:
     Call WPS at 1–608–301–3243.

     Patients and health care providers can call for more information about using and authorizing this benefit. 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 people locate cancer clinical trials and cancer information.

     The NCI’s Web site (http://www.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 NCI’s Web site (http://www.cancer.gov/clinicaltrials/) 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 using specific criteria, including the trial’s location. Instructions for finding trials being conducted at military treatment facilities are available on the Veterans Affairs and Department of Defense Beneficiaries Digest Page at http://www.cancer.gov/clinicaltrials/digestpage/VA-DOD on the Internet.

     CIS information specialists also offer live, online assistance through the LiveHelp^® link on the NCI's Web site at http://www.cancer.gov/ (click on “LiveHelp online chat”) or at https://cissecure.nci.nih.gov/livehelp/welcome.asp on the Internet. Through LiveHelp, information specialists provide Internet users with help in navigating the NCI’s Web site, searching for clinical trials, and finding answers to questions about cancer. The service is available from 9:00 a.m. to 11:00 p.m., Eastern time, Monday through Friday.

     TRICARE’s guide to cancer clinical trials is available at http://tricare.osd.mil/cancertrials/ on the Internet.

     See also Agreement Allows TRICARE Beneficiaries to Continue Participation in NCI Cancer Trials at http://www.tricare.mil/pressroom/news.aspx?fid=381 on the Internet.

Related NCI materials and Web pages:

• National Cancer Institute Fact Sheet 2.11, Clinical Trials: Questions and Answers ¹
  (http://www.cancer.gov/cancertopics/factsheet/Information/clinical-trials)
• Clinical Trials Home Page ²
  (http://www.cancer.gov/clinicaltrials)
• Veterans Affairs and Department of Defense Beneficiaries Web Page ³
  (http://www.cancer.gov/clinicaltrials/digestpage/VA-DOD)

For more help, contact:

NCI's Cancer Information Service
Telephone (toll-free): 1–800–4–CANCER (1–800–422–6237)
TTY (toll-free): 1–800–332–8615
LiveHelp^® online chat: https://cissecure.nci.nih.gov/livehelp/welcome.asp

Glossary Terms

A term for diseases in which abnormal cells divide without control and can invade nearby tissues. Cancer cells can also spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is a cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is a cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is a cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood. Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system. Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord. Also called malignancy.

The Cancer Information Service is the National Cancer Institute's link to the public, interpreting and explaining research findings in a clear and understandable manner, and providing personalized responses to specific questions about cancer. Access the CIS by calling 1-800-4-CANCER (1-800-422-6237), or by using the LiveHelp instant-messaging service at https://cissecure.nci.nih.gov/livehelp/welcome.asp. Also called CIS.

A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical study.

Forms of treatment that are used in addition to (complementary) or instead of (alternative) standard treatments. These practices generally are not considered standard medical approaches. Standard treatments go through a long and careful research process to prove they are safe and effective, but less is known about most types of CAM. CAM may include dietary supplements, megadose vitamins, herbal preparations, special teas, acupuncture, massage therapy, magnet therapy, spiritual healing, and meditation. Also called CAM.

To heal or restore health; a treatment to restore health.

The process of identifying a disease, such as cancer, from its signs and symptoms.

Any substance, other than food, that is used to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition. Also refers to a substance that alters mood or body function, or that can be habit-forming or addictive, especially a narcotic.

In medicine, a mineral is a nutrient that is needed in small amounts to keep the body healthy. Mineral nutrients include the elements calcium, magnesium, and iron.

The National Cancer Institute, part of the National Institutes of Health of the United States Department of Health and Human Services, is the Federal Government's principal agency for cancer research. The National Cancer Institute conducts, coordinates, and funds cancer research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer. Access the National Cancer Institute Web site at http://www.cancer.gov. Also called NCI.

PDQ is an online database developed and maintained by the National Cancer Institute. Designed to make the most current, credible, and accurate cancer information available to health professionals and the public, PDQ contains peer-reviewed summaries on cancer treatment, screening, prevention, genetics, complementary and alternative medicine, and supportive care; a registry of cancer clinical trials from around the world; and directories of physicians, professionals who provide genetics services, and organizations that provide cancer care. Most of this information, and more specific information about PDQ, can be found on the NCI's Web site at http://www.cancer.gov/cancertopics/pdq. Also called Physician Data Query.

A study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.

A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.

An inactive substance or treatment that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.

In medicine, action taken to decrease the chance of getting a disease or condition. For example, cancer prevention includes avoiding risk factors (such as smoking, obesity, lack of exercise, and radiation exposure) and increasing protective factors (such as getting regular physical activity, staying at a healthy weight, and having a healthy diet).

To come back or to return.

Checking for disease when there are no symptoms. Since screening may find diseases at an early stage, there may be a better chance of curing the disease. Examples of cancer screening tests are the mammogram (breast), colonoscopy (colon), Pap smear (cervix), and PSA blood level and digital rectal exam (prostate). Screening can also include checking for a person’s risk of developing an inherited disease by doing a genetic test.

The extent of a cancer in the body. Staging is usually based on the size of the tumor, whether lymph nodes contain cancer, and whether the cancer has spread from the original site to other parts of the body.

In medicine, treatment that experts agree is appropriate, accepted, and widely used. Health care providers are obligated to provide patients with standard therapy. Also called best practice and standard of care.

Adding nutrients to the diet.

Care given to improve the quality of life of patients who have a serious or life-threatening disease. The goal of supportive care is to prevent or treat as early as possible the symptoms of a disease, side effects caused by treatment of a disease, and psychological, social, and spiritual problems related to a disease or its treatment. Also called comfort care, palliative care, and symptom management.

Treatment.

A nutrient that the body needs in small amounts to function and stay healthy. Sources of vitamins are plant and animal food products and dietary supplements. Some vitamins are made in the human body from food products. Vitamins are either fat-soluble (can dissolve in fats and oils) or water-soluble (can dissolve in water). Excess fat-soluble vitamins are stored in the body’s fatty tissue, but excess water-soluble vitamins are removed in the urine. Examples are vitamin A, vitamin C, and vitamin E.