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Education And Information Resources |
Education And Information Resources
You can never have enough information about every aspect of your disease. With decisive information, better care decisions can be made to guide you to optimal interventions. Therefore, you may wish to check the World Wide Web where the National Cancer Institute (NCI) maintains a site called Physician Data Query (PDQ) http://cancernet.nci.nih.gov/pdqfull.html . The site, which includes information on clinical trials, cancer treatment, and prevention, maintains a directory of facilities with accredited cancer care programs. PDQ and another NCI site, CancerNet http://www.cancer.gov/ also provide information (in English and Spanish) on supportive care for digestive problems, nausea, vomiting, fatigue, and depression.
The National Cancer Institute: A Reliable Source of Current and Comprehensive Cancer Information
Information is a critical component of shared decision making for any patient with a diagnosis of cancer and any individual known to be at high risk of developing cancer. The challenge facing patients, families and individuals at risk is finding readily available, authoritative and current information from a trustworthy source. The World Wide Web, a worldwide network of computers on the Internet, now provides a readily accessible, inexpensive and popular source of almost any type of information imaginable. The National Cancer Institute (NCI), the major source of federal funding for cancer research, has developed a computerized information system called PDQ (Physician Data Query) to make the most current information on the treatment of cancer, cancer screening and prevention and approaches to the management of disease and treatment-related complications more widely known. Information in the PDQ system is based on careful and ongoing reviews of the medical literature by cancer experts. PDQ also contains up-to-date information on clinical trials that are being conducted to evaluate new approaches to cancer treatment in patients with cancer and new approaches to cancer screening, and prevention in those at risk of developing cancer; a directory of physicians who care for cancer patients and individuals with significant risk factors, and a directory of facilities that have accredited cancer screening and/or cancer care programs.
NCI staff also developed, maintain and update CancerNet, a World Wide Web site that features information from PDQ and CANCERLIT, a bibliographic database of published cancer literature, educational resources produced by other NCI divisions and offices, a glossary of medical terms and links to complementary web sites with supplemental cancer information. The address is: http://cancernet.nci.nih.gov.
PDQ and CancerNet are reliable resources that cancer patients, those at significant risk of developing cancer and their loved ones can options with medical experts as well as prevention and screening options that may be use to find up-to-date information to enable them to discuss management appropriate for family members and actively participate in the decision-making process.
- The cancer information developed for the PDQ system and CancerNet contains treatment summaries for adult and pediatric cancers, supportive care information on common complications of cancer or its treatment, and statements on approaches to cancer prevention and screening. The summaries feature information on:
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the prognosis (chance of recovery)
staging (extent of spread)
histopathology (tumor cell type)
state-of-the-art (effective or standard) treatment options
promising clinical research (research studies, protocols or clinical trials)
the management of complications (supportive care)
the early detection of cancer (screening)
approaches in use to prevent cancer development (cancer prevention)
- The treatment summaries in PDQ and CancerNet are written by cancer specialists with input from experts around the country and are available in both English and Spanish. Treatment options are provided for more than 90 different types of cancer, and information on rare cancers is being added over time. They are provided in two formats:
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Statements for health care professionals written in highly technical medical terminology that contain references to medical literature containing information that supports the use of the treatment options discussed; and
Complementary summaries written for patients and the public that contain references to additional, less-technical educational resources written for cancer patients, their families and the public. These summaries are designed to complement discussions with a health care professional and to be shared with patients when prognosis and treatment options are discussed rather than to serve as a primary and freestanding source of treatment advice.
Because treatments that are appropriate for patients with cancers that are very localized (have not spread from the site of origin) are often markedly different from those that can be offered to a patient whose tumor has spread to other organs (metastasized), PDQ and CancerNet generally present treatment options by stage of disease (extent of spread). In certain types of cancer, other considerations, such as the anatomic location of the tumor or the type of cells that have become cancerous, can be more important in the selection of treatment. In such situations, these features govern the discussion of treatment options. When there is no effective therapy, PDQ and CancerNet recommend that patients consider participation in clinical trials that are evaluating new approaches to treatment.
Supportive Care and Survivorship Issues
PDQ and CancerNet provide information on support that can ease the physical and psychosocial adverse effects of cancer or its treatment, such as pain, digestive problems, nausea and vomiting, fever, itching, fatigue, depression and grief and loss. These statements are also available in both English and Spanish.
Cancer survivors serve on the Editorial Boards that develop these summaries and participate in the refinement of existing summaries. Survivors are also setting priorities for the development of new topics.
Information on screening for cancers of the breast, cervix, colon and rectum, stomach, oral cavity, ovaries, prostate, skin and testes is also summarized in PDQ and CancerNet. Each summary provides information on the strength of the evidence supporting the use of the technique
- to detect cancer in asymptomatic individuals and
- to reduce cancer mortality.
Evidence-based statements on the prevention of cancers of the lung, breast, cervix, colon and rectum, ovaries and skin are also available. These summaries provide information on matters that increase or decrease cancer risk and information on current approaches to cancer prevention.
Information on Cancer in Racial and Ethnic Minorities. In the near future, users will be able to search CancerNet for information on the incidence, mortality, screening, prevention and treatment of cancer in racial and ethnic groups. The resource features data from an NCI monograph on racial and ethnic patterns of cancer and prompts that point the user to the PDQ screening, prevention, treatment statements and clinical trials that may be appropriate for patients and individuals at high risk of developing certain cancers. A fully functional resource for both health professionals and patients on cancer in African-Americans was implemented on CancerNet 1997. This prototype is the model for a similar resource for Alaskan Natives, Asian Americans, Hispanic Americans, Native Americans, Native Hawaiian/Pacific Islanders and white non-Hispanics.
Keeping PDQ and CancerNet Information Current. All of the treatment, supportive care and screening and prevention summaries in PDQ and CancerNet are regularly updated by the members of four Editorial Boards. These boards are composed of more than 60 prominent physicians, nurses, psychiatrists, pharmacists, statisticians and social workers with expertise in the care of cancer patients. The Editorial Board that reviews information on the treatment of cancers that occur in adults and the Supportive Care and Survivorship Board each meet nine times a year; the boards that review information on pediatric cancers and on Cancer Screening and Prevention each meet five times a year. At each board meeting, members review and discuss information from recently published medical and scientific articles to update existing statements and develop new ones. An International Advisory Board of Editors comprising more than 100 specialists with expertise in cancer treatment, supportive care, screening and prevention complements and extends the expertise of these four core Editorial Boards.
Information on Clinical Trials in PDQ and CancerNet
New methods of cancer screening, prevention and treatment must be proved safe and effective before they can become standards of care and made widely available to individuals at risk and cancer patients. PDQ and CancerNet contain summaries of interventions under evaluation in patients that are designed to identify new and better ways to help cancer patients. These organized research programs are called research studies, clinical trials or protocols.
PDQ and CancerNet provide two overviews on the design and conduct of clinical trials: one written for health professionals and one for patients and their families. These summaries describe what protocols or clinical trials are, what their objectives are, the types of research questions they attempt to answer, and how the trials are conducted. These summaries also discuss the many biomedical, ethical and practical concerns that pertain to participation in cancer clinical trials.
There are many types of clinical trials. They range from studies of new methods to prevent, detect, diagnose, control and treat cancer to studies of new measures to enhance comfort and quality of life or measure the psychological impact of cancer on individuals. On average, about 1,500 clinical trials that actively seek patient participation are summarized in PDQ and CancerNet. All of the clinical trials supported by the NCI are listed in PDQ and CancerNet. NCI also invites physicians conducting clinical trials that are being supported by other sources to submit them to PDQ and CancerNet. These clinical trials are listed following review and approval by a board of cancer specialists that ensures that each trial is appropriate for use in the patient population that is to be studied.
- The review evaluates whether the clinical trial adequately meets the following basic criteria:
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Is it based on rational scientific information?
Is it likely to yield some useful information?
Is it unduly risky to patients?
Are the entry criteria clear and complete?
Is the statistical section clear and complete?
If the board decides that the trial does not meet one or more of the criteria, the chairperson sends a letter explaining the board's concerns to the principal investigator, who is invited to modify the protocol document to respond to their concerns or to clarify information in the protocol document. Once the principal investigator responds, the protocol is re-reviewed and a decision is made. More than 93 percent of the non-NCI sponsored trials submitted for review are included in PDQ.
- New treatments often employ new methods of surgery, radiation therapy, chemotherapy and/or biological therapy. New treatments may be given alone or in combination with one another. Clinical trials in PDQ and CancerNet are classified by:
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the research goal (prevention, screening, treatment or management of complications)
the primary tumor type (colon or breast cancer, for example)
specific drugs or biologic substances
the modality, or type, of treatment (surgery, radiotherapy,
chemotherapy, biological therapy, screening, chemoprevention or supportive care)
accrual status (open, closed, approved but not yet active, or investigational)
the study phase (Phase I, II, III or adjuvant trial)
sponsorship (NCI-sponsored, pharmaceutical or other organizational support)
Information on clinical trials is provided in two formats: physician-oriented and consumer-oriented summaries. The physician-oriented summaries provide technical details on the objectives of the study, the patient entry criteria (medical requirements) and the regimen, including drug dosages and schedules. In addition, each clinical trial includes the names, addresses and phone numbers of the physicians conducting the study. Information on clinical trials in PDQ and CancerNet is updated monthly. It's easy to search PDQ and CancerNet to identify clinical trials for a specific type and stage of cancer as well as a specific location (one or more cities, states, countries or ZIP codes) in the United States, Canada, Europe, Asia and several other locations.
Concise, consumer-oriented summaries were created for all active breast cancer clinical trials in PDQ and CancerNet in 1996. These single-paragraph summaries describe the rationale, purpose, entry criteria and regimen so patients can understand the basic design of the trials and find those for which they might be eligible. Special links in the text of the summary enable patients searching CancerNet to click on words that are hyperlinked to a glossary containing the definitions of medical terms used in the trial summaries. Each summary also provides the names and phone numbers of a physician conducting the study and a link to the longer and more technical summary written for physicians. NCI staff evaluated and refined the breast cancer prototype in collaboration with the patient advocate community and can distribute consumer-oriented summaries for all types of trials on CancerNet, patient advocate web sites and newsletters. In the future, short summaries will be integrated into the online PDQ system as well.
The Phases of a Clinical Trial
Clinical trials are designed to demonstrate whether a therapy is effective and/or if it is more effective than another treatment. They are designed to take advantage of what has worked in the past and to improve on this foundation. For example, a clinical trial may compare the best-known surgical treatment with a newer operation to see if one produces more cures and/or causes fewer side effects than the other.
Clinical trials are carried out in stages called phases of investigation. Each phase is designed to discover different types of information. Each phase depends on, and builds on, information from an earlier phase. Patients may be eligible for studies in different phases, depending on their general condition and the type and stage of their cancer.
Most of the treatments we now consider standard therapies were first shown to be effective in clinical trials.
Phase I trials
The purpose of a Phase I study is to find the best way to give a new treatment and, if it is a new drug or biologic substance, how much of it can be given safely. Important findings of Phase I trials include the documentation of anticancer activity and any adverse effects associated with the treatment. Each new treatment (or new dose level) is given to a small number of patients under the careful eye of health professionals who evaluate each individual for any harmful side effects. Each patient is carefully assessed for anticancer effects via the measurement of tumor masses that are present at the beginning of the treatment. If any or all of the masses shrink appreciably, the patient is said to have responded to the treatment. Although each treatment has been thoroughly tested in laboratory animal studies, side effects in humans are not always predictable. For this reason, Phase I studies may involve significant risks and are offered only to patients whose cancers have spread and who are not likely to be helped by other known treatments.
Phase II trials
Once a safe dose and schedule for the treatment are established in Phase I trials, it can be advanced to a Phase II study, where investigators try to determine how effective it is against different types of cancer. Usually, 30 to 40 patients with a specific type and stage of cancer receive a Phase II treatment. Anticancer activity and adverse effects are assessed and a tentative response rate to the new therapy is established. If at least one out of five patients (20 percent) responds, the treatment is judged active against their tumor type. A treatment that shows this level of activity will move to Phase III. Since more patients receive the new treatment in Phase II trials, each patient is carefully assessed for new or unusual side effects.
Phase III trials
Phase III trials are comparative studies that require large numbers of patients, sometimes many thousands, to determine the superiority of one treatment over others in a special type of clinical trial. In Phase III trials, patients are assigned to a treatment group in a random (by chance) manner to avoid any bias in the selection of treatment for any patient. One group of patients receives the standard care for that type and stage of cancer (the control group). The other group receives the new treatment. At the end of the study, treatment outcomes are compared. All patients are monitored closely for anticancer and adverse effects. A Phase III trial is conducted under strict rules that terminate the study if outcomes show that one treatment is significantly superior to the other or if the treatments appear equal in efficacy but the side effects of one treatment are significantly more severe than the other.
Adjuvant trials
Adjuvant trials are conducted to determine if the administration of a supplemental form of therapy (the adjuvant therapy) can improve the chance of a cure in patients with localized cancer who are known to have a significant risk of recurrence after surgery or radiation therapy. Adjuvant trials of chemotherapy that compared surgery alone against surgery plus chemotherapy in women with breast cancer showed that the combination of surgery and chemotherapy led to fewer recurrences than the use of surgery alone. As a result of these studies, surgery and chemotherapy has become the standard therapy for many women with localized breast cancer who are at significant risk of recurrence.
Taking Part in a Clinical Trial
Clinical trials offer patients the most up-to-date care available. Patients who take part in clinical trials have the first opportunity to benefit from new research and can make a very important contribution to medicine and science. The medical requirements for participating in a clinical trial depend on many factors. Patients who want to know more about clinical trials should review the summary on the design of clinical trials in PDQ and CancerNet and talk with their physicians about their options.
- Patients should learn as much as they can about the trials before making up their minds. A cancer specialist is often the best person to counsel a patient about the selection of a standard option or a clinical trial. Patients should ask questions about the clinical trials that are available before deciding whether to participate in one. Some of the right questions to ask include:
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What is the purpose of the study?
What are other choices and their advantages and disadvantages? Are there standard treatments for my case and how does the study compare with them?
What does the study involve? What kinds of tests and treatments are done and how are they done?
What is likely to happen in my case with or without this new research treatment?
How could the study affect my daily life?
What side effects could I expect from the study?
How long will the study last? Will it require an extra time commitment on my part?
Will I have to be hospitalized? If so, how often and for how long?
Will the treatment be free? Will I incur any costs? If so, what are they?
If I am harmed as a result of the research, what treatment would I be entitled to?
What type of long-term follow-up care is part of the study?
This directory contains the names, addresses, telephone numbers and medical specialties of more than 24,000 physicians who spend the majority of their time managing cancer patients or individuals at significant risk of developing cancer. These names have been compiled from the membership directories of 17 medical specialty organizations. All of the physicians conducting clinical trials listed in the PDQ and CancerNet are in the directory file.
Since 1997, CancerNet users can search for genetic counselors by name, city, state and by the professional services required. Genetics counselors submitting applications for inclusion in the CancerNet database must have (1) a professional degree in genetics counseling or (2) a professional license or national certification, and (3) a membership in an approved national oncology or genetics society.
PDQ and CancerNet list more than 2,500 health care organizations that have certified programs of cancer care, and more than 9,500 mammography screening facilities approved by the Food and Drug Administration.
Note: The inclusion of individual doctors, counselors and organizations in the directory file does not imply endorsement by the NCI.
Patients and others who want to know more about cancer and how it may be screened for, prevented and treated can also obtain information from PDQ and CancerNet by contacting the NCI's Cancer Information Service (CIS). The CIS is staffed by trained information specialists who provide up-to-date information and answer questions from the public, cancer patients and their families, health care professionals and the media about cancer and cancer-related issues. Counselors who speak Spanish are available. Individuals with questions can call a toll-free number, 1-800-2-CANCER (1-800-222-6237), TTY 1-800-332-8615, to be connected to the CIS office serving their area. The counselors at the CIS use PDQ to obtain information about cancer screening, prevention, treatment, supportive care and clinical trials.
Patients and the public can access the PDQ database directly in several different ways. The PDQ system can be searched interactively over the Internet via the NCI's Information Associates Program, the National Library of Medicine's (NLM) MEDLARS system or through commercial and nonprofit information providers who have licensed PDQ as an online or CD-ROM service. A user needs a computer, a modem and telecommunications software to link over a standard telephone line to a remote computer containing the PDQ system. Those using a CD-ROM product need a CD-ROM reader. Although not essential, it is also highly desirable to have a printer so that the information seen on the screen can be produced for review. Information on vendors can be obtained from the International Cancer Information Center by contacting the Licensing Coordinator at 301-296-2907.
The NCI disseminates PDQ data in English and Spanish through its CancerFax service, which enables people to obtain access to cancer treatment information via a facsimile machine. Users dial the CancerFax telephone number (301-202-5874) from the telephone handset on their fax machine, request a contents list, enter a code number from the CancerFax contents list for the desired information and follow the voice prompts to receive a faxed image of any of the information that is available through the CancerNet Mail Service. The service is available 24 hours a day and there is no cost to the user other than the telephone call. In addition, CancerFax provides current information on the NCI's scientific journals, its patient education materials and commercial vendors that distribute PDQ.
Another source of PDQ information is CancerMail, an electronic mail service. An e-mail user simply submits an electronic message (e-mail) to the ICIC's mail server (cancermail@icicc.nci.nih.gov) with the word help in the body of the message to get a table of contents and instructions for requesting information. Almost all of the information on CancerFax can be found on CancerMail. (Graphics cannot be transmitted on CancerMail.) Like PDQ, CancerMail and CancerFax are updated each month.
As has been discussed, users can also get information from CancerNet, the ICIC's web site located at http://cancernet.nci.nih.gov. Users need a computer equipped with a modem and telecommunications software and Internet browsing software. Almost all of the information from PDQ is available in CancerNet, including all of the cancer information summaries for health professionals and patients, in English and Spanish, and the abstracts for all 1,500 or so ongoing clinical trials. In addition, CancerNet contains more than 80 topic-specific citations and abstract digests derived from the monthly updates to CANCERLIT, a bibliographic database of more than 1.2 million citations, also produced by the ICIC. CancerNet includes nearly 20 different CANCERLIT topic searches in the field of genetics, NCI news articles, educational booklets and bulletins, a variety of scientific and science policy publications and information produced by NCI researchers. The ease of updating a web site makes it a particularly suitable medium for transmitting time-sensitive material, including late-breaking news from the NCI and the National Institutes of Health (NIH).
Both CancerNet and the CancerNet Mail Service have greatly improved foreign access to PDQ information. One-third of the users on the Internet are accessing these services from foreign countries. By September of 1997, CancerNet was accessed more than 1.8 million times a month, and a growing number of medical facilities, cancer centers, community health information networks and health-oriented web sites link to CancerNet.
Along with the wide range of information contained in CancerNet, ICIC provides hyperlinks to other web sites that offer valuable information. In keeping with the ICIC's goal of offering current, reliable information, each site is reviewed by an editorial board comprising health professionals, health educators and patient advocates before a link is established. Each review is designed to determine if the site meets the following criteria:
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Is the information related to the ICIC's mission of information dissemination?
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Is the information something that the ICIC does not already provide that would be useful to users?
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Is the information accurate and up-to-date?
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Is there an acceptable review process in place to maintain the quality and currency of the material on the site? Review board members also consider the following characteristics in their review of each site:
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Information on which users would base important health care decisions: reviewers are asked to carefully review any information in this category that may be incorrect or misleading,
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Inaccuracies that compromise meaning (missing text, misaligned tables): whether or not to link to a site with problems of this nature is decided by assessing the importance of information and the extent to which the information is likely to be misinterpreted, and
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Organizational and cosmetic flaws: whether or not to link to a site with these problems will be decided by assessing the importance of information versus the difficulty of locating specific details, and the unprofessional appearance of the information.
Once a link has been established, each site is reviewed at least twice a year. These criteria and information on how to request a link from CancerNet can be found on CancerNet's global resources page.
The information in PDQ is developed, maintained and disseminated by the staff at the International Cancer Information Center. The staff includes content and technical specialists whose goal is to ensure that PDQ is of high quality and easily accessible to health professionals, patients and the public. The author gratefully acknowledges their work and the many contributions of the patients who have advanced our knowledge on cancer screening, prevention, treatment and support.
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