As you may know, October is National Breast Cancer Awareness Month. This is the perfect month for the Army of Women members to shine! Some of you may be thinking, "What can I do to help? How can I make a difference?" Well, the Army of Women has the answers for you! To start, read on to learn about an exciting breast cancer research study that needs African-American breast cancer survivors AND their female relatives with a history of breast cancer, from ANYWHERE in the US. If you are a breast cancer survivor, see how you can participate. If you are NOT a breast cancer survivor, but have relatives who are, take action and invite them to join the Army of Women and let them know about this study today! The researchers need them–and possibly you, too! Together you may be able to take part in important research investigating the higher rates of breast cancer in young African-American women. Read on to learn how.
If you aren't able to participate in this study, you can still do YOUR part: forward the Call to Action to someone you know who might be interested. As a member of the Army of Women you have an important opportunity to accelerate breast cancer research by forwarding our e-blast and helping to fill this study. And that's not all! YOU can make a difference by inviting your friends, family, colleagues–ANYONE you know over the age of 18–to join the Army of Women. Together, we can reach our goal of ONE MILLION strong!
Women of African ancestry living in the United States have higher rates of premenopausal breast cancer than women of European ancestry. They are also more likely to die of breast cancer. Is it possible that there are certain hereditary genetic mutations that may explain why? A research team at the University at Buffalo thinks the answer is yes. And they need African-American women who were diagnosed with breast cancer of any stage, including metastatic disease and DCIS, to help them find out.
This study is open to African-American breast cancer survivors in the United States who have at least one living blood relative (mother, sibling, cousin, grandparent, niece, etc) who is also a breast cancer survivor. There is no time limit since diagnosis and it is OK if you are currently receiving treatment. If you are interested in learning more, please read on!What's the study about?
The research team is searching for new genetic risk factors for breast cancer in African-American women by studying DNA from women who have been diagnosed with breast cancer, their female relatives who have had breast cancer, and possibly also their female relatives who have not had breast cancer. They are also going to investigate whether there are similarities in tumor type that develop within the families that take part in the study.What's involved?
If you agree to participate in the Jewels in Our Genes study you will be contacted by phone to answer questions about your breast cancer diagnosis and your relatives who are also breast cancer survivors. If you appear to be eligible and you decide to join the study, you will be asked to provide a small sample of saliva so that the researchers can collect your DNA. This involves spitting into a tube. The researchers will mail you a saliva collection kit, which will include detailed instructions on how to collect the sample and return it to the researchers. You will mail the kit back to the researchers, at no cost to you.
You will also be asked to complete a short questionnaire about your health, lifestyle, and family history of breast cancer. The questionnaire will be mailed to you and you will mail it back to the researchers, at no cost to you. You will also be asked to give the research team permission to access your medical records, which will be used to confirm the type of breast cancer you had.
Finally, you will be asked to help recruit your relatives who are breast cancer survivors into the study, and also possibly one relative who has not been diagnosed with breast cancer. Based on the information you provide in the questionnaire, the research team will decide which of your relatives you should invite to join the study. You will receive a letter in the mail asking you to provide these family members with a copy of the study brochure and to ask them to call the research team if they would like to participate.
The researchers need to enroll up to 150 families, or approximately 400 women, in this study.Who is conducting the study?
Heather Ochs-Balcom, PhD, University at Buffalo, Buffalo, NYWhere?
Anywhere in the United States, all necessary participation is handled through the mail.Who can participate?
You can join the Jewels in Our Genes study if you match ALL of these MAIN categories:
• You are a woman older than 18 years of age
• You consider yourself to be Black/African American
• You were diagnosed with breast cancer of any stage, including metastatic disease and DCIS. There is no time limit since diagnosis and it is OK if you are currently receiving treatment.
• You have tested negative for the BRCA 1 and 2 mutations (if known - if you do not know your status, you can still participate in the study)
• You have at least one living female blood relative who was diagnosed with breast cancer of any stage, including metastatic disease and DCIS. The relative can be first degree (mother, daughter, sister) or second degree (cousin, grandparent, aunt, or niece). There is no time limit since diagnosis and it is OK if she is currently receiving treatment.
• You live in the United States
After you RSVP, the researcher will ask you additional questions to be sure that this study is a right fit for you.
This conference will address all levels of basic, population, clinical and multidisciplinary research related to cancer. The goals of this conference are to bring together physicians, scientists, health professionals and health care leaders working in a variety of disciplines to discuss the latest findings in their fields, to foster collaborative interdisciplinary interactions and partnerships and to stimulate the development of new research in cancer health disparities.
..."researchers found that despite universal healthcare, significant differences in survival across socioeconomic groups persist in Ontario: overall and cancer-specific survival of patients from poorer communities was lower than that of patients residing in more affluent neighborhoods. "Contrary to what has been reported in studies from the U.S., we have found that stage of cancer at time of diagnosis does not account for any substantial component of the difference in survival across social groups," said Dr. Booth. Instead, factors such as differences in cancer biology, the presence of other illnesses, access to treatment, and quality of care might play a role."
Overhaul of NCI Cooperative Group Program Needed to Ensure
It Can Continue to Conduct Important Cancer Clinical Research
WASHINGTON -- Because a robust national clinical trials network is essential to achieving advances in cancer treatment and prevention, the National Cancer Institute (NCI) should preserve and strengthen the capabilities of the Clinical Trials Cooperative Group Program through an overhaul of its organization, management, and funding, says a new report of the Institute of Medicine. The program has been instrumental in establishing many therapies routinely used to treat cancer patients, said the committee that wrote the report. But it faces many difficulties at present that undermine its ability to facilitate the multi-institutional collaborations necessary to conduct large, late-stage trials that answer important research questions single institutions and the private sector cannot or do not tackle.
Inefficient processes for developing trials, complicated government oversight, and a lack of sufficient resources hinder the program's ability to efficiently and effectively design and conduct trials, the committee concluded. To reduce waste and streamline the program, the report calls for consolidating redundant administrative and support functions that are handled separately by each of the 10 cooperative research groups that comprise the program. It recommends strategies to more effectively incorporate scientific advances into clinical trials and a boost in funding and other incentives to encourage and support health professionals' participation in studies. And it urges public and private health plans to fully cover the nonexperimental costs of study participants' health care during trials to eliminate financial disincentives that lead patients to decline enrollment or to drop out.
"Cooperative group studies have steadily improved the care of cancer patients for more than 50 years, but the program is at a breaking point," said committee chair John Mendelsohn, president of the University of Texas M.D. Anderson Cancer Center in Houston. "Its effectiveness is being undermined at a time when the opportunity for improving cancer care has never been greater because of rapid advances in biomedical research. A few isolated or partial measures won't suffice. The program urgently needs changes across the board if it is going to continue producing the kind of studies necessary to answer crucial and fundamental questions about how to successfully treat and prevent cancer, which can't be answered through other means."
The Cooperative Group Program involves more than 3,100 institutions and 14,000 investigators who enroll more than 25,000 patients in clinical trials each year. Research by the cooperative groups has contributed to the introduction of treatments and drug indications that have led to improved survival for cancer patients.
Successful trials depend on sufficient involvement by physicians and other health professionals. Cancer care providers devote significant amounts of time and effort to recruit patients into trials and manage their care during the studies. Inadequate reimbursement and recognition for their efforts are increasingly deterring their willingness to initiate or participate in trials, the report concludes.
The committee called on NCI to increase the amount it reimburses clinicians for the costs of managing each of their patients in trials, and to pay for their time and effort spent on designing and carrying out clinical trials. Medical centers should take into account health professionals' participation in clinical trials during their consideration for tenure and promotions. NCI should establish a centralized credentialing system for investigators and sites that wish to participate in a national trials system to increase consistency across sites and eliminate the burden of recredentialing with different cooperative groups. This system also would provide a way to eliminate research sites with low levels of recruitment or inadequate data management capability.
Insurance providers' variable and uncertain coverage of patients' care during studies and overly restrictive eligibility criteria deter patient involvement in clinical trials. The committee called on public and private health plans to cover all nonexperimental costs of participation in clinical studies. Patient eligibility criteria should allow the broadest participation possible to facilitate more rapid recruitment and allow broader generalizations about study results to be made. Greater involvement by patient advocates could help facilitate this change, the committee added. Advocates can provide valuable input to study design and procedures, safety and confidentiality issues, and other factors important to potential research participants.
Funding for the Cooperative Group Program is lower now in inflation-adjusted dollars than it was in 1999, and constitutes less than 3 percent of NCI's total budget. Current funding is insufficient to support the number of trials the groups undertake, especially as trials are becoming more complex with a new focus on developing therapies tailored to the molecular and genetic characteristics of individual patients' cancers. NCI should allocate a larger portion of its research portfolio to the program, and if adequate funding is not available, cooperative groups should reduce the number of NCI-funded trials undertaken to a quantity that can be fully supported.
The report was sponsored by the U.S. Centers for Disease Control and Prevention, Food and Drug Administration, National Cancer Institute, American Society of Clinical Oncology, Association of American Cancer Institutes, and C-Change. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. A committee roster follows.
What does the Task Force say about breast cancer screening?
On November 16, 2009, the Task Force released the following new guidelines for healthcare providers:
• The Task Force does not recommend that women automatically begin mammography screening at the age of 40. Instead the Task Force recommends that the decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take into account patient context, including the patient’s values regarding specific benefits and harms.
• The Task Force recommends every other year screening mammography for women aged 50 to 74 years.
• The Task Force concludes that there is not enough evidence to determine the harms and benefits of screening mammography in women over 74.
• The Task Force recommends against healthcare providers teaching breast self-examination.
• There was not enough evidence for the Task Force to make a recommendation on clinical breast examinations, digital mammography, or MRI
Does this mean that women in their 40s will not be able to get mammograms?
NO. That is a misrepresentation of what the Task Force said. The Task Force said that the decision to start regular mammography before age 50 should not be automatic but should be an individual decision and take into account the patient’s values regarding specific benefits and harms. It gives women more control over their health care decisions.
Has breast cancer screening had a significant impact on mortality from breast cancer?
No, over 40,000 women continue to die of breast cancer each year, despite the emphasis on breast cancer screening in our country. To change this, we must address the facts about breast cancer and not simply accept what we want to believe. The fact is that all breast cancers are not equal and that we don’t currently have tools for “early detection” that are good enough for the life-threatening breast cancers.
But doesn’t early detection save lives?
Not necessarily. Some breast cancers are slow-growing and have a good prognosis, whenever they are found, whether small or large. Other breast cancers are aggressive and fast growing, and we don’t have the tools to catch them early enough or treatments that will work.
Why doesn’t mammography work as well for women in their 40s?
Younger women have more dense breast tissue, making mammography less accurate. Also, mammography is better at detecting slower growing tumors more common in older women, than the fast-growing, aggressive tumors more often found in younger women. And the balance of benefit vs. harm changes as women get older since the likelihood of breast cancer increases with age. The disease is relatively rare in younger women.
But shouldn’t a woman in her 40s have a mammogram if she feels a lump?
Certainly. The Task Force recommendations are meant to be guidelines for broad public health policy for healthy women with no symptoms, and an average risk for breast cancer. These guidelines are not meant for any woman with an increased risk or for any woman who feels a lump or change in her breast. Women who have any concerns need to visit their doctors and may need diagnostic mammograms. Mammograms taken to assess a problem are not the kind of mammograms we are talking about with these guidelines.
What’s the harm in trying to detect breast cancer early, even if our methods don’t work that well?
The harms from screening too early or too often include increased false positives, leading to increased imaging and radiation exposure, biopsies and scarring that can affect the accuracy of future mammograms, and anxiety. There is also the harm of overdiagnosis of breast cancer. This would involve treatment of cancers that would never be life threatening, and treatment of cancers that may regress, or go away on their own. The treatments for breast cancer are not aspirin, they are toxic and can be life threatening; the scenario of overdiagnosis should not be taken lightly.
A mammogram/self examination found my breast cancer and I am alive today so these methods clearly work, right?
It is understandable that many people would think that they are alive today because their breast cancer was discovered through screening. But this makes many assumptions that just can’t be known, such as how life-threatening the cancer would have been, if the cancer may have regressed on its own, and whether the cancer would have been discovered in other ways and would have had the same prognosis. The point is, individual stories are not evidence of effectiveness. Detection, screening, breast cancer…these are all very complicated issues.
Look at bone marrow transplant for breast cancer. It seemed to make sense: if chemotherapy works, maybe even more chemotherapy would work better. Bone marrow transplant is a method of giving patients lethal doses of chemotherapy, then replacing their bone marrow. It was believed that level of dosing would kill all the cancer. And in some cancers, usually blood based, it worked. So women with breast cancer received this incredibly toxic treatment outside of clinical trials. When the trials were actually performed and we had the scientific evidence, it showed that not only was bone marrow transplant not more effective than standard treatment, but it actually resulted in deaths from the treatment itself. Health care should always be based on the highest level of scientific evidence or well designed studies to get that evidence.
Isn’t it better to give women a simple public health message?
These issues are complex. We would like it to be a simple message, but we also want it to be truthful. Women deserve the truth and are capable of understanding the facts and making their own decisions.
Aren’t these guidelines really about saving money?
These recommendations are not about saving money or about the current health care debate. The Task Force began their review of breast cancer screening well over two years ago. The recommendations and accompanying scientific literature were published in the Nov. 17 issue of Annals of Internal Medicine. The recommendations were made by scientists and physicians based on a systematic review of the evidence of the benefits and harms and an assessment of the net benefit. There were no economists involved and the recommendations were not based on considerations of cost.
