Patient Navigator

When faced with a decision about your own or a loved one’s medical care, you are often overwhelmed by the sheer immensity or complexity of the situation.   It is very tempting to accept a doctor or other medical care provider’s prescription for treatment and proceed directly.  Many doctors are amazing – helping patients understand the scope of their condition, their treatment options, and why one recommended course would be better for them than another.

However, sometimes people are discouraged from asking questions or doing research that would make them more comfortable with the proposed treatment plan, or even expose them to options that have not been considered.  Sadly, some care providers perceive that they are being “challenged” when a patient asks questions; others simply don’t take or make the time for a patient’s questions.

This type of situation is terribly unfortunate. It is only by communicating openly and fully with your care providers that you can make the decisions that best meet YOUR needs. Every person has the right to fully participate in all decisions regarding his or her own health care.

This legal doctrine is called the right to informed consent. The World Health Organization, the European Parliament, the American Hospital Association and many other organizations support and endorse the right of all people to make their own healthcare decisions in consultation with their caregivers.

The website  http://www.informedmedicaldecisions.org is dedicated to supporting and educating people on their rights to actively participate in medical decision making.

As a patient or caregiver, you have the right and responsibility to obtain as much information as you need to be able to commit to a course of treatment or test process. Some questions/statements that can help get the information you need include:

• Can you explain this to me?

• Where can I get more information?

• Can you write this down? Draw me a picture?

• How is this helpful to me?

• Are there any risks involved?

• Can you recommend a safe alternative?

• What are the probable side effects? What percentage of people experience these side effects?

• Does my insurance cover this treatment?

• What is the time frame for this decision – immediately, days, weeks, months?

• If I choose not to go ahead with this recommendation, what would the consequences be?

• How much time would I have to get a second opinion?

• I want to think about this before I make a decision.

• I don’t feel comfortable with this recommendation.

• Is there any else I can do or try?

By becoming actively involved in your care, you are likely to be more satisfied with your decisions.  Both patients and doctors benefit when patients are well-informed and play a significant role in deciding how they are going to treat or manage their health conditions.

Informed patients feel better about the decision process. Their decisions are more likely to match up with their preferences, values, and concerns. These patients are more likely to stick with the regimens the treatment requires, and they often end up rating their health after treatment as better.

Submitted by Debora Harvey, Patient Navigator

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I have three wonderful kids.  They are smart, funny, athletic, and – thank heavens – healthy.  Aside from infrequent viruses, periodic stomach aches and the occasional twisted ankle, they don’t slow down for much.

One of my worst nightmares is one of my children being diagnosed with a condition that requires a bone marrow transplant.  My kids are biracial, which means that the chance of finding a match in the existing pool of registered bone marrow donors is miniscule.

According to an article in The Washington Post on Tuesday, June 1, only about 3 percent of donors listed in the National Marrow Donor Program’s “Be the Match” registry are of mixed race. Washington Post Article

People who are multiracial are one of the fastest growing demographic groups in the United States.  However, despite donor drives and new efforts to utilize social networking to increase the number of donors, they are also the most under-represented in the marrow registry.

As the number of conditions that are potentially treatable with bone marrow transplants grows, so does the demand for donors.  The first line is a family member but often, no family member is a match.  Next, doctors turn to the national registry and even international registries to find matches for critically ill patients.  For single race patients, the chances are slim.  For those of mixed race, those chances are virtually non-existent.

I have been registered with the National Marrow Donor Program since 1991.  I have been called twice with the news that I was a potential match for a critically ill individual.  Both times I unquestioningly proceeded with the next level of screening necessary to determine a true match.  Sadly, both times, the potential recipient died before it was possible to schedule a donation.  In some ways I felt the loss of their lives deeply.  Lives that were lost that maybe, just maybe, a few ounces of my marrow cells could have had a role in saving.

For more information on registering to be a donor, click on  http:/www.marrow.org

Guest editor Debora Harvey, Patient Navigator

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The Internet is an amazing tool for people researching health conditions, possible treatment options or medical specialists.  An unlimited amount of information is available at the click of a mouse.  This is good, right? 

Unfortunately, the reality is a double-edged sword. Yes, the Internet lets people become well informed, but it has can also foster “cyberchondria” and “analysis paralysis.”

I now see my Great Aunt Frieda in a whole new light.  I’m glad that she lived before the Information Revolution.  You see, Auntie F, as we called her, was a hypochondriac.  She constantly visited her doctor for a multitude of problems.  It was easy then because doctors could spend more time with patients and it cost less.  So her doctor would listen to her, reassure her that she was not dying of the symptom of the week, and see her again in a week or two to hear about her newest issue.   She lived, in nearly perfect health, until a peaceful death at age 95.

The 21^st century gives us a new twist to this story.  “Cyberchondriacs” spend hours at the computer screen, typing in symptoms or fears, wading through the results, both accurate and inaccurate, and convincing themselves they have a certain condition.  Often, they will print out reams of documentation and present themselves to their doctors, having already diagnosed their “condition” and determined a course of treatment.  To make matters worse, bogus information may appear as genuine evidence-based medicine and is often flanked by marketing ploys offering miraculous treatments

In a May 2002 research report, the Pew Internet & American Life Project (www.pewinternet.org) called them “health-seekers.”  “About 6 million Americans go online for medical advice on a typical day,” said Pew in its Vital Decisions report. “That means more people go online for medical advice on any given day than actually visit health professionals (on a given day),” Pew said, comparing the 6 million estimate figures to an unspecified, but lower number provided by the American Medical Association.

What is the cost of cyberchondria?  It is estimated in the millions of dollars and rising every year due to unnecessary visits to the doctor’s office or emergency room, un-needed and possibly invasive tests.

Online medical information is wonderfully helpful and useful in many situations.  But, like anything else, moderation is the key.  Choosing sources wisely, using good sense to edit the results, and getting OFF of the computer when it all becomes too much are important keys to successful use of online health information.  To learn more about evaluating health information on the Internet, visit http://tinyurl.com/Evaluate-Info-On-Internet

Submitted by Guest Editor Debora Harvey, Patient Navigator LLC

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Scientists have mapped specific genes that turn normal healthy cells into cancerous cells through The Cancer Genome Atlas Project (TCGA).

Through the TCGA, researchers have now developed a more reliable scientific method to identify these genes.   As this research is shared around the globe, more accessible and effective cancer treatment options are being discovered.  The ultimate goal of the TCGA is to create a catalogue of these “defective” genes, thereby offering increased detection, and ultimately, better prevention and treatment of cancer.     

As healthy cells grow and divide, they not only produce more healthy cells but also kill off cells that are no longer needed.  A cancer cell is produced when an otherwise healthy cell grows abnormally or does not die off when it should.  These cancerous cells then form a mass or tumor.

Through the TCGA, researchers are trying to pinpoint why these specific genes change and how that can lead a cell to become cancerous.  Once this information is gathered, cancer treatment will move to a more targeted form of treatment.  Doctors will target only the abnormal gene, as opposed to today’s standard treatment of chemotherapy, which affects the whole body.  Such a change in treatment will be beneficial because standard chemotherapy kills off cancerous cells but also some healthy cells in the process.  If researchers can instead identify the “defective” genes and target them directly, healthy cells will stay intact and be less affected by the cancer treatment.

For example, the National Institutes of Health recently announced that TCGA identified distinct subtypes of glioblastoma multiforme, the most common form of malignant brain cancer in adults.  In the past, doctors treated this type of brain tumor as a single disease, whereas now they know that glioblastoma multiforme is, in fact, four distinct molecular subtypes.

In addition, through the TCGA, researchers have also discovered that response to chemotherapy and radiation differed by gene subtype.  Although the current standard of treatment will not change overnight, these new discoveries will help doctors to tailor a cancer treatment plan using genetic information.  

Originally a pilot project, TCGA has turned out to be quite a success in demonstrating the value of cancer research.  In the fall of 2009, President Obama announced that the National Institutes of Health will spend $275 million to expand TCGA to other types of cancer, thus opening the door for more specific treatment options and hopefully more cures.

To learn more about the cancer cells we have in our body, please read our January 27 blog post at: http://patientnavigator.com/blog/2010/01/27/we-all-carry-cancer-cells/

For further information on The Cancer Genome Atlas Project, please visit:

http://cancergenome.nih.gov

http://www.nih.gov/news/health/jan2010/nci-19.htm

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Access to investigational therapies is a highly debated topic in the medical world.  Investigational therapy involves drugs that are being scientifically tested but not yet approved by the Food and Drug Administration (FDA). Often these drugs are offered through programs such as “compassionate use programs,” and “expanded access programs” to allow seriously ill patients access to new drugs before they have obtained FDA approval.

The processes of acquiring FDA approval can, in some instances, take up to ten years.  In the interim, because of where they are offered (typically in large cities), the associated costs (many insurance companies do not cover experimental treatments), and the strict eligibility requirements, most patients have limited access to these potentially life-saving therapies.

The FDA has realized the need for an overhaul.  In the past year, representatives from the FDA, the pharmaceutical industry and the medical profession have convened to re-interpret the rules and regulations of investigational therapies to form a new framework that allows greater access to more patients.

One such change centers on whether drug manufacturers can charge for the investigational trial drug.  Before, the regulations were unclear on what the manufacturer could charge and for what.  Under the new guidelines, the FDA has made it very clear that manufacturers can recover the cost of the product but can not make a profit.   The FDA hopes that with costs down, more people will seek out investigational therapies as a treatment option.

Additionally, the FDA is now requiring full-safety reporting for all patients in compassionate use programs, a requirement that exceeds the usual reporting protocol for serious adverse events.  While in theory this is good medical practice, companies could be resistant to this regulation since it would require more staff to follow up on patients, thereby raising a company’s bottom line, which could turn a company away from implementing compassionate use programs. 

While it is a positive development that the FDA has recognized the need for change, it is still a complicated process to gain access to investigational, but potentially life-saving therapies.  

To learn more about the new FDA guidelines and expanded access programs, please visit. http://www.medscape.com/viewarticle/711719.  You should also read the National Cancer Institute’s Fact Sheet on investigational drugs at:  http://tinyurl.com/ybmh4mk.

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To the general public, these words can be overwhelming.

Even to people in the healthcare industry or those helping a loved one cope with a serious illness, the words “clinical trials” can conjure up images of desperate medical experiments with little hope of success. In reality, this stigma is unwarranted. Medical advances and breakthroughs can and have resulted from clinical trials. Without them, we wouldn’t have many of the treatments we have today. 

In short, clinical trials are research studies that allow for new and promising therapies to emerge from the laboratory to the bedside, comparing new, investigational therapies against the standard, current therapies.  Trials occur in well-defined phases.

Phase I trials:  These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe.  A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.

Phase II trials:  A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works.  Phase II studies usually focus on a particular type of cancer.

Phase III trials:  These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization).  Phase III trials often enroll large numbers of people and may be conducted at many doctors’ offices, clinics, and cancer centers nationwide

Often patients seek out clinical trials after all other standard therapies have failed. To qualify, a patient must complete a physical exam, give a full medical history and, if eligible, sign a consent form before receiving the experimental drug. 

The rules and regulations vary from trial to trial and a person’s past treatment history can dictate whether they are eligible or ineligible. Additionally, many insurance carriers restrict access to clinical trials, often denying coverage for doctor visits, laboratory tests, or medications associated with trials. Out of pocket expenses can be astronomical and make trials an unaffordable choice for many.  

Recognizing a need for change, the medical community and certain state legislatures have been trying to secure better coverage for clinical trials. Just recently, Texas, Oregon, and New Mexico passed laws requiring an improved level of care for people involved with clinical trials.  Even the sickest patients have a powerful voice, Use yours to seek from your legislators better insurance coverage to help gain access to potentially life saving clinical trials. 

To learn more about clinical trials, the National Cancer Institute’s site at www.cancer.gov There is an entire section devoted to clinical trials, including public search engines.   

Submitted by Heather Matthews, Cancer Research Specialist at Patient Navigator, LLC

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