Division of Cancer Prevention and Control


The American Stop Smoking Intervention Study (ASSIST)

ASSIST is a collaborative effort between the NCI and the American Cancer Society (ACS), along with state and local health departments and other voluntary organizations to develop comprehensive tobacco control programs in 17 states. Its purpose is to demonstrate that the wide-spread, coordinated application of the best available strategies to prevent and control tobacco use will significantly accelerate the current downward trend in smoking and tobacco use. The five year intervention phase began in 1993 and continues through 1998 (Phase II) during which smoking control strategies, adapted from science-based models developed through NCI research and other sources, will be implemented. Through ASSIST, media, policy, and cessation support will be delivered to target groups using the health care system, schools, the worksite, and other community channels.

National 5-A-DAY Program

The National 5-A-Day Program, designed to encourage Americans to eat five or more servings of fruits and vegetables every day, represents a significant public/private enterprise between NCI and the Produce for Better Health Foundation. NCI's role as the educator and providing credible information plays an integral part in communicating the 5-A-DAY message. Research grants awarded to state health agencies, universities, and cancer centers are evaluating the effect of 5-A-DAY activities in schools, workplaces and other community settings.

Cancer in Minorities and the Underserved

Reducing cancer in minority and underserved populations is facilitated by the mobilization of professional and lay leaders in the community to address the specific cancer needs of that community as well as through coalition building among health-related, academic and community organizations. The NCI supports three such initiatives in an effort to address the cancer prevention and control needs of certain populations. The National Black Leadership Initiative on Cancer (NBLIC), as of January 1993, has establised 47 coalitions and is forming 19 others within six regional areas of the United States: Northeastern, Mid-Atlantic, Mid-Western, Southwestern, Western, and Southeastern. A major goal of the NBLIC is to address the barriers that limit or prevent Black Americans from gaining access to quality cancer control services. The National Hispanic Leadership Initiative on Cancer (NHLIC) brings together Hispanic investigators from five major Hispanic groups whose outreach activities strategically cover areas with a large population of Latino residents and representation from five major Hispanic groups. The NHLIC has established nine coalition sites where baseline data collection and needs assessments are underway with the aim of advancing the Healthy People 2000 goals on cancer in Hispanics. The third of these initiatives, the Appalachia Leadership Initiative (ALIC) on Cancer is targeted to all persons, particularly those who are medically underserved, who reside in the region of the United States known as Appalachia. Among the ALIC's priorities are the promotion of smoking cessation, diet modification, and early detection screening and treatment. The four awards made in 1992 cover 330 counties in the Appalachian region from New York to Georgia.

Cancer has become the leading cause of death for Alaskan Native women and the second leading cause of death among both Native American and Native Hawaiian women. The Native American Women's Cancer Initiative was developed by the NCI in response to emerging cancer needs and issues of Native American women. The goals of ongoing research include: the identification of barriers to culturally appropriate quality cancer control services including screening, appropriate follow-up, diagnostic, treatment and rehabilitation programs for cancers common and/or disproportionately elevated among indigenous women; and the reduction of cancer risk behaviors in Native American women.

Women's Health Trial: Feasibility Study in Minority Populations

NCI also has been exploring a dietary intervention, specifically fat restriction, to reduce the risk of developing breast, colorectal, and possibly cardiovascular diseases in postmenopausal women in the Women's Feasibility Study in Minority Populations. The study, which began recruitment in August 1992, targets minority and underserved women and addresses the probability of achieving and sustaining dietary modification. The study will also endeavor to determine whether adoption of a low fat dietary pattern will reduce breast and colorectal cancer incidence and reduce overall mortality from cancer and heart disease in postmenopausal women. Elements of the study design and the generated results will contribute to and be coordinated with the projected 10-year, trans-NIH, multidisciplinary Women's Health Initiative, especially those portions that focus on community-based interventions and diet/micronutrient studies.

National DES Educational Program for Health Professionals and the Public

An NCI-initiative is in progress to provide information and recommendations to women exposed to diethylstilbestrol (DES), their families, and health care professionals. DES, a synthetic nonsteroidal estrogen, was frequently prescribed to pregnant women in several areas of the United States from 1945 to 1955 and less frequently from 1955 to the early 1970s, with the intention of preventing miscarriages and other pregnancy complications.

Physicians and other health care professionals will be informed of the risks faced by patients exposed to DES and to their children. Standards for treatment also will be developed and widely disseminated. Methods will be developed and tested to reach those individuals at risk for medical conditions associated with exposure to DES with appropriate educational messages.

Screening for Prostate, Lung, Colorectal, and Ovarian Cancers

Through this 16-year randomized trial, 37,000 men will be screened for four years for prostate, lung, and colorectal cancers and 37,000 women will be screened for the same period of time for lung, colorectal, and ovarian cancers. The trial, which began patient accrual in 1993, is employing the following screening modalities: prostate specific antigen (PSA) and digital rectal exam for prostate cancer; chest x-ray for lung cancer; 60-cm flexible sigmoidoscopy for colorectal cancer; and ovarian palpatation, CA125 blood test and transvaginal sonography for ovarian cancer. Equal numbers of men and women are being followed with routine medical care as controls. There will be a 10-year follow-up of both study subjects and controls to determine the effects of screening for those four sites on disease specific mortality. Diagnostic biopsy specimens will be examined to characterize genetic alterations in these screen-detected cancers. The anticipated benefits of this large scale screening trial include the identification of biomarkers that will pinpoint cancers in their earliest stages as well as serve as intermediate endpoints that will allow prevention trials to be conducted in a more efficient and cost effective manner.

Prostate Cancer Prevention Trial

A Prostate Cancer Prevention Trial (PCPT) using finasteride (Proscar) began accrual in October of 1993. This study is an intergroup study in the Community Clinical Oncology Program (CCOP) clinical trials network. As prostate cancer is influenced by androgens, the study tests the ability of finasteride, a 5-alpha- reductase inhibitor of androgen synthesis, to reduce the incidence of prostate cancer. Because finasteride blocks the production of the hormone dihydrotestosterone, the trial will also focus on whether the long-term prophylactic use of the drug prevents the occurrence of benign prostate hyperplasia. The trial will involve 15,000-20,000 men at risk for prostate cancer. Subjects are randomized to receive finasteride or placebo for up to ten years. The endpoint of the study will be diagnosis of clinically significant prostate cancer.

Breast Cancer Prevention Trial

The Breast Cancer Prevention Trial (BCPT) with tamoxifen is underway in the Community Clinical Oncology Program (CCOP) clinical trials network. Implemented through the National Surgical Adjuvant Breast and Bowel Project (NSABP), this trial is testing the ability of tamoxifen, an anti-estrogen medication used in postsurgical treatment of early stage breast cancer, to prevent the development of breast cancer in women at increased risk for developing the disease. Based on results from treatment clinical trials in which tamoxifen reduced the incidence of breast cancer in the opposite breast in women already diagnosed with breast cancer, scientists estimate that tamoxifen has the potential to reduce the incidence rate of breast cancer in high-risk women by at least 30 percent. Approximately 16,000 women at increased risk for breast cancer due to age, family history, and personal history (i.e., age at first birth, age at menarche, and previous breast biopsies) are being randomized to receive tamoxifen (20 mg/day) or placebo for an initial period of five years. The study, which will last ten years, is being implemented in over 250 nucleus and sub-centers across the United States and in Canada. Samples are being collected from the trial participants to analyze any inherent genetic factors that may contribute to the risk of developing breast cancer in this population. In addition, an in-depth evaluation of any breast tissue abnormalities that are detected at biopsy in BCPT participants will be analyzed for both inherited and acquired genetic mutations.

Community Clinical Oncology Program (CCOP)

The Community Clinical Oncology Program (CCOP) is a network of cancer specialists, primary care physicians, and other health professionals who conduct both clinical treatment research and cancer prevention and control research studies. The primary objectives of the CCOP encompass the development of clinical trials for effective implementation of cancer prevention and control research in multi-institutional settings in early detection and screening, chemoprevention, smoking, patient management, and rehabilitation. The current program involves 49 CCOPs including over 300 hospitals and 2,800 physicians. Several large-scale chemoprevention trials are are being implemented through this network to study the effectiveness of various agents to prevent cancer such as The Breast Cancer Prevention Trial with tamoxifen and the recently initiated Prostate Cancer Prevention Trial with finasteride (Proscar).

Minority-Based Community Clinical Oncology Program (MBCCOP)

The Minority-Based Community Clinical Oncology Program (MBCCOP) was initiated to provide minority cancer patients with access to state-of-the-art cancer treatment and control technology. MBCCOP consists of eight programs with greater than fifty percent of new cancer patients from minority populations and involves 31 hospitals and 300 physicians. Since funding began in 1990, patient accrual from these eight MBCCOPs has grown to account for approximately 10 percent of all ethnic minorities enrolled in NCI- approved clinical trials. In addition to providing a service to their patient populations, the MBCCOPs allow for study of minority recruitment and accrual to cancer clinical trials.

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