Demystifying Breast Cancer:

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Separating Fact from Fiction During Breast Cancer Awareness Month

Breast Cancer Awareness Month, which takes place each October, is a global campaign that aims to raise awareness about breast cancer, encourage early detection through regular screenings, and provide support to those affected by the disease. During this month, various organizations, foundations, and individuals come together to educate and inform the public about breast cancer prevention, treatment, and survivorship.

One of the significant challenges in combating breast cancer is the prevalence of myths and misconceptions surrounding the disease. These myths can contribute to fear, anxiety, and even misinformation, leading to delays in seeking medical help or pursuing necessary preventive measures.

In this article, we will focus on debunking some of the most common breast cancer myths.

Myth 1: Only Older Women Get Breast Cancer

Fact: While breast cancer is more prevalent among older women, it is a disease that knows no age limits. Breast cancer can strike at any stage of a woman’s life, including young adulthood. The diagnosis of breast cancer in young women can be particularly devastating, as they are often at the peak of their careers, building families, or pursuing their dreams.

Myth 2: You Can’t Get Breast Cancer if It Doesn’t Run in Your Family

Fact: Breast cancer is usually not directly inherited through genes. Having a family history of breast cancer can increase the risk, but most cases occur in women without any family history. Many factors, both genetic and environmental, can influence the development of breast cancer. Some genetic mutations like BRCA1 and BRCA2 are associated with higher risk, but these mutations are relatively rare and account for only a small percentage of all breast cancer cases. Therefore, even if breast cancer does not run in your family, it doesn’t mean you are immune to the disease.

Myth 3: Breast Cancer is Always Painful

Fact: Many women mistakenly believe that if they are not experiencing pain or discomfort in their breasts, they are free from the risk of breast cancer. However, this is far from the truth. One of the most deceptive traits of breast cancer is its ability to develop silently, often without causing pain or discomfort. By the time it becomes painful or symptomatic, it may have reached an advanced stage, making it more challenging to treat.

The presence of the following signs should raise concern:

  • Lumps or Masses: One of the most recognizable signs of breast cancer is the discovery of a lump or mass in the breast or underarm area.
  • Skin Changes: Changes in the skin over the breast, such as redness, dimpling, puckering, or an orange-peel-like texture, can be indicative of breast cancer. These changes may not be painful but should prompt immediate medical evaluation.
  • Nipple Changes: Unexplained changes in the nipples, such as inversion, scaling, crusting, or discharge (other than breast milk in nursing mothers), should be examined by a healthcare professional.
  • Breast Pain: While breast pain is not a reliable indicator of breast cancer, persistent, unexplained breast pain or discomfort should not be ignored. It is essential to seek medical advice to rule out any underlying issues.

Myth 4: If You Have a Lump in Your Breast, It’s Always Cancer

Fact: It’s important to understand that not all breast lumps indicate cancer. In fact, the majority of breast lumps are benign, meaning they are non-cancerous. While it’s always prudent to take any changes in your breasts seriously and consult a healthcare professional, it’s helpful to know that there are many other potential causes of breast lumps.

One common cause of benign breast lumps is cysts. Cysts are fluid-filled sacs that can develop in the breast tissue. They are typically round or oval in shape and can feel smooth or rubbery to the touch. Cysts may appear and disappear on their own or fluctuate in size with hormonal changes throughout the menstrual cycle. While cysts are usually harmless, they can sometimes be painful or uncomfortable.

Another benign condition that can cause breast lumps is a fibroadenoma. Fibroadenomas are solid, non-cancerous tumors that often occur in younger women. They are typically smooth, firm, and movable. Fibroadenomas are influenced by hormonal changes and can grow in size or become more tender during pregnancy or certain hormonal therapies. Although fibroadenomas are not cancerous, it is essential to have any new or changing breast lumps evaluated by a healthcare professional to confirm the diagnosis.

Other potential causes of benign breast lumps include breast infections (mastitis), lipomas (soft fatty tumors), and traumatic injuries to the breast tissue. In some cases, hormonal imbalances, such as those associated with certain medications or conditions like polycystic ovary syndrome (PCOS), can also contribute to the development of breast lumps.

Myth 5: Only Women Get Breast Cancer

Fact: Although rare, men can develop breast cancer. Men have breast tissue too, although it is typically less developed than women’s breast tissue. Any changes in the breast area should be monitored. These changes may include a lump or thickening in the breast or under the nipple, changes in the size or shape of the breast, nipple discharge (often bloody), or changes in the skin over the breast area.

When it comes to breast cancer in men, many of the risk factors are similar to those for women. Age is a significant factor, with the risk increasing as men get older. Family history of breast cancer, genetic mutations such as BRCA2, exposure to estrogen, and certain medical conditions such as Klinefelter syndrome or liver disease are also known to increase the risk for male breast cancer.

Although breast cancer in men is relatively uncommon, it is still important to raise awareness and provide education about this topic. Men should be encouraged to understand their breast health, know the potential risk factors, and be proactive in seeking medical attention if any concerns arise. Early detection and intervention can greatly improve the prognosis and outcome for men diagnosed with breast cancer.

Myth 6: Bras with Underwire Cause Breast Cancer

Fact: Numerous scientific studies have been conducted to investigate the potential link between underwire bras and breast cancer. The results consistently show that there is no credible evidence supporting the notion that wearing underwire bras increases the risk of developing breast cancer.

Myth 7: Deodorants Can Cause Breast Cancer

Fact: Similarly there is no scientific evidence to support the claims that deodorants and antiperspirants cause breast cancer. These products are used by millions of people worldwide, and rigorous scientific research has not established any direct link between their use and the development of breast cancer. Rather than worrying about everyday products, we should focus on known breast cancer risk factors, such as genetics, family history, lifestyle choices, and regular breast health checks. These factors have a more significant impact on breast cancer risk, and understanding and addressing them can contribute to overall breast health and well-being.

Myth 8: Breast Cancer Is A Single Disease

Fact: Breast cancer is not a singular disease but rather a diverse and complex group of different types of tumors. These tumors can vary in their biological characteristics, behaviors, and responses to treatment.

The classification of breast cancer takes into account various factors, including:

  • Receptor Status: Breast cancer tumors can be classified based on the presence or absence of hormone receptors, such as estrogen receptors (ER) and progesterone receptors (PR), as well as human epidermal growth factor receptor 2 (HER2). These classifications guide treatment decisions and are crucial in determining the most effective therapies.
  • Histology: Breast cancer tumors can have different histological characteristics, which means they can look different under a microscope. For example, some breast cancers are invasive ductal carcinomas, while others are invasive lobular carcinomas, each with its distinct features.
  • Genetic Subtypes: Advances in genetic research have led to the identification of specific genetic subtypes of breast cancer, such as triple-negative breast cancer (negative for ER, PR, and HER2) and HER2-positive breast cancer. These subtypes may respond differently to targeted treatments.
  • Stage and Grade: Breast cancer is staged based on the size of the tumor, lymph node involvement, and whether it has spread to other parts of the body. The grade of the tumor also reflects its aggressiveness.

Recognizing the diversity within breast cancer is important because different types of breast cancer may require different treatment approaches. Treatment plans are tailored to the specific characteristics of the tumor and the individual patient, taking into account factors like age, overall health, and personal preferences.

Additionally, ongoing research into the molecular and genetic aspects of breast cancer continues to reveal more about the complexity of the disease, leading to more precise treatments and improved outcomes. By dispelling the myth that breast cancer is a single disease, we highlight the importance of accurate diagnosis and individualized treatment plans, ultimately contributing to better care and outcomes for those affected by breast cancer.

Myth 9: Mammograms Cause Breast Cancer

Fact:  Mammograms, a type of X-ray imaging, are a tool in the early detection of breast cancer, identifying abnormalities that may not be noticeable during a physical examination. However, concerns about the potential risks associated with radiation exposure have been raised.

Radiation can be harmful, particularly at high doses, but the dose used in mammography is extremely low. The level of radiation involved in a mammogram is carefully regulated and tailored to minimize any potential risks. Modern mammography machines are designed to deliver the lowest radiation dose possible while producing clear and detailed images.

It is understandable to have concerns about radiation exposure, but it’s essential to consider the bigger picture. The benefits of regular mammograms far outweigh the minimal radiation exposure involved. Early detection of breast cancer through mammography can significantly increase the chances of successful treatment and improve long-term outcomes.

Myth 10: Stress Causes Cancer

Fact: While it is well-established that chronic stress can have a negative impact on overall health and well-being, including weakening the immune system, there is no conclusive scientific evidence to support the claim that stress directly causes cancer.

While stress may contribute to an individual’s overall health, it is only one piece of the puzzle when it comes to cancer development. That being said, managing stress and adopting healthy coping mechanisms are still important for overall well-being. Engaging in activities such as exercise, meditation, or pursuing hobbies can help reduce stress levels and improve mental health.

Rather than living our lives in fear that stress alone will lead to cancer, it is more helpful to prioritize overall health through a balanced diet, regular physical activity, and appropriate cancer screenings. These proactive measures have been shown to have a more direct impact on reducing cancer risk.

Breast Cancer Awareness Month serves as a reminder that knowledge is power. By dispelling these myths and promoting accurate information, we can empower women to make informed decisions about their breast health. Breast cancer is a complex and multifaceted disease, and understanding the facts is essential in the journey toward prevention, early detection, and improved outcomes.

Becoming an Empowered and [ACT]IVATED Breast Cancer Patient

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Patient Empowerment Network (PEN) is committed to helping educate and empower patients and care partners in the breast cancer community. Breast cancer treatment options are ever-growing with research advancements in treatments and testing, and it’s important for patients and families to educate themselves with health literacy tools and resources on the latest information in breast cancer care. With this goal in mind, PEN kicked off the [ACT]IVATED Breast Cancer program, which aims to inform, empower, and engage patients to stay abreast of up-to-date information in breast cancer care. 

The [ACT]IVATED Breast Cancer program is aimed at newly diagnosed breast cancer patients, yet it is beneficial at any stage of disease. [ACT]IVATED Breast Cancer helps patients and care partners stay in the know about the latest options for their breast cancer, provides patient activation tools to help overcome barriers to accessing care, and powerful tips for self-advocacy, coping, and living well with cancer.

Breast Cancer Disparities

With more focus on disparities in breast cancer outcomes, research studies are starting to reveal actionable information on genetic differences. A recent study uncovered a racial disparity among cancer types that are hormone receptor-negative but HER2-positive. While treatment has been successful in white patient groups, the outcomes have been less successful in Black patient groups. The study also noted key gene mutations in the MAPK pathway occur more frequently in Black patients, which warrants further investigation.

Lisa Hatfield and Dr. Demetria Smith-Graziani

Breast cancer expert Dr. Demetria Smith-Graziani from Emory University School of Medicine shared updates about her breast cancer research. “…what we found is that regardless of the type surgery Black women were reporting more severe pain compared to white women, and so that’s what prompted me to engage in my most recent research project…the reason that I’m looking at those specific set of factors is because there are a number of psychological components to the way that we feel pain, such as anxiety, depression and yes trust that are linked to the way that we experience pain and how severe that pain is and how much that pain affects our lives.

Proactive Steps to Improve Breast Cancer Care

Knowledge gained from research studies can be utilized by patient advocates, and actions can be taken to improve breast cancer care and in the evolution of research efforts for all patients. Dr. Smith-Graziani discussed the importance of clinical trials in driving advancements in breast cancer research and treatments. “…all of the current treatments we have that are FDA-approved were approved because of the results from clinical trials that previous patients participated in…And we won’t get any new advancements in breast cancer treatments and come up with even better, more effective treatments, unless we are able to do more clinical trials with more patients. The other part is that in the past, most of the participants of clinical trials have been pretty much the same, they have been mostly white, mostly have insurance, mostly of a higher socioeconomic status, and those patterns continue today, we are still trying to get the patients in clinical trials to reflect the true population of the United States. And in order to know that clinical trials are effective for everybody, we need to have everybody in those trials.”

Dr. Demetria Smith-Graziani

Dr. Smith-Graziani also explained breast cancer subtypes and why it’s vital for patients to learn about their breast cancer subtype. “When we are looking at the cancer cells under the microscope, we look at specific proteins in these cells, and based on what proteins we see, we designate it as positive or negative for the estrogen receptor, the progesterone receptor, or a protein called HER2. When a cancer expresses the estrogen or progesterone receptor, that means that it feeds off of those hormones that your body makes, and that’s why we refer to it as hormone receptor-positive…And it’s important that we know what subtype of breast cancer you have, because it affects the type of treatment that you can get.”

Learning about family history of cancer is also another key to staying proactive in breast cancer care. Dr. Smith-Graziani explained, “So breast cancer definitely can be hereditary, we are aware of some forms of inherited breast cancers, and we have identified certain mutations in genes that are passed down along family lines, that increase the risk of getting breast cancer…ask your family members about their cancer history so that you’re aware of it, and then ask your oncologist if they recommend genetic counseling or testing.”

Another fundamental step in proactive breast cancer care is for patients to ask about their treatment plan. Dr. Smith-Graziani shared advice for patients. “…in addition to potential side effects are how long is my treatment meaning how long am I going to have to stay in the infusion center if I’m getting an IV medication? Or how many months of treatment do I need to get? And then how much time do I need to take off of work? Am I going to be able to work while getting my treatment, so it’s those little things which aren’t so little that are important to discuss, so that the patients can get the best overall picture about how each treatment will affect them in the short and the long term.”

Dr. Smith-Graziani stressed the value of getting your questions answered and also the value of additional expert opinions. “I think it’s important for patients to be as informed as possible to make sure that they are getting all of their questions answered by their doctor, and if you don’t feel like your questions are getting answered, if you don’t feel like your concerns are being appropriately addressed or acknowledged, please make sure that you get a second or a third opinion and talk to another doctor to see if they can answer your questions.”

[ACT]IVATED Breast Cancer Program Resources

The [ACT]IVATED Breast Cancer program series informs, empower, and engage both the overall community and breast cancer patient groups who experience health disparities. The series includes the following resources:

[ACT]IVATED Expert Interviews

[ACT]IVATED Resources

Though there are breast cancer disparities, patients and care partners can be proactive in educating themselves to help ensure optimal care. We hope you can take advantage of these valuable resources to aid in your breast cancer care for yourself or for your loved one.

[ACT]IVATION Tip:  

By texting EMPOWER to +1-833-213-6657, you can receive personalized support from PENs Empowerment Leads. Whether you’re a breast cancer patient, or caring for someone who is, PEN’s Empowerment Leads will be here for you at every step of your journey. Learn more.

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Confused About Immunotherapy and Its Side Effects? You Aren’t Alone

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“You don’t look like you have cancer.”

More than one patient undergoing immunotherapy to treat cancer has reported hearing statements like that. Immunotherapy is one of the recent advances in cancer treatment that belie the stereotypes about the effects of cancer treatment. 

The side effects of immunotherapy are different from those associated with chemotherapy and radiation. However, that does not mean immunotherapy does not have side effects. Patients and care partners need to be aware of these potential side effects and to be vigilant in addressing them with their oncologists because they can signal more serious complications if left untreated.

What is Immunotherapy?

Despite the increase of immunotherapy treatment options in recent years and considerable media attention paid to advancements in this field, there remains confusion about immunotherapy and its side effects. Many cancer patients are unaware of whether immunotherapy treatments are available for their specific diagnosis. Others don’t know that genetic profiling of their tumors is usually required to determine if immunotherapy is an option and not all treatment centers routinely conduct genetic profiles of tumors. A  survey by The Cancer Support Community found that the majority of patients who received immunotherapy knew little to nothing about it prior to treatment and were unfamiliar with what to expect.

Immunotherapy works by manipulating the patient’s immune system to attack cancer cells. It is perceived as gentler and more natural than chemotherapy and radiation, without the same destructive effect on the body’s healthy tissues.  This, combined with a lack of prior understanding of immunotherapy, can lead patients and care partners ill-prepared for possible side effects.

Furthermore, immunotherapy is a category of therapies, not a single type of treatment. There are a variety of immunotherapy drugs, most of which are administered via infusion.  Side effects will vary by drug, the cancer and its location, treatment dose, and the patient’s overall health.

The following are the most common types of immunotherapy.

  • Checkpoint inhibitors use drugs to block proteins in the patient’s immune system that would otherwise restrain the immune system, often referred to as taking the “brakes” off the immune system.
  • CAR-T therapy modifies the patient’s T-cells in a lab to enhance their ability to bind to cancer cells and attack and kill them.
  • Oncolytic virus therapy uses genetically modified viruses to kill cancer cells.
  • Another therapy uses cytokines (small proteins that carry messages between cells) to stimulate the immune cells to attack cancer.

Immunotherapy can be part of combination therapy. It might be combined with chemotherapy. It might be used to shrink a tumor that is then surgically removed.  Or multiple immunotherapy drugs might be used simultaneously.

What Are The Side Effects?

With immunotherapies, side effects typically occur when the immune system gets too revved up from the treatment. The most common side effects for immunotherapy treatments are fatigue, headache, and fever with flu-like symptoms. Some people also experience general inflammation often in the form of a rash. Many melanoma patients report blotchy skin discoloration, called vitiligo, during treatment. These milder side effects can usually be managed with over-the-counter remedies and adjustments to daily activities.

For checkpoint inhibitors, the fastest growing segment of immunotherapy treatments, mild side effects occur in 30% – 50% of patients. Serious side effects typically occur in less than 5% of patients. (See “Understanding Immunotherapy Side Effects” from the National Comprehensive Cancer Network and the American Society of Clinical Oncology.)

Less common side effects are blisters, joint pain, thyroid inflammation, and colitis (inflamed colon resulting in diarrhea with cramping). Some patients who receive CAR T-cell therapy develop a condition known as cytokine release syndrome, which causes fever, elevated heart rate, low blood pressure, and rash. 

In rare cases, immunotherapy has resulted in lung inflammation, hepatitis, inflammation of the pituitary, and detrimental effects on the nervous and endocrine systems. In most cases, the conditions clear up when treatment ends.  However, there have been outcomes in which immunotherapy caused diabetes or tuberculosis.

“Overall there are fewer side effects [with immunotherapy],” explained Dr. Justin Gainor, a lung and esophageal cancer specialist at Mass General during an Immunotherapy Patient Summit hosted by the Cancer Research Institute. “But the immune system can affect anything from the top of the head down to the toes. Any organ has the potential to be affected.”

As the application of immunotherapy has expanded, so has our understanding of the potential side effects. Like most medical treatments, how one person responds to immunotherapy can be different from another even when the cancer diagnosis and drug therapy are the same.

The essential thing patients and care partners need to know about side effects is they should always be reported to their oncologist or nurse oncologist.

Why Patients Should Talk to Their Provider About Immunotherapy Side Effects

Because immunotherapy has created newer therapy options, there isn’t the volume of experiences as with older treatments. The infinite number of variables that patients provide once a treatment moves beyond clinical trials and into the general patient population generate more diverse outcomes.  And, as most therapies are less than 10 years old, there hasn’t been an opportunity to study the long-term effect of these therapies. This is why oncologists advise patients and their caregivers to be extra vigilant in noting any changes experienced during and after treatment.

Many side effects are easy to treat but medical providers want patients to be forthcoming in discussing any and all side effects. This is in part to improve understanding of side effects, but also because a mild cough or a case of diarrhea might be harbingers of a more systemic issue that will grow worse if left untreated.

Patients should not be hesitant to discuss side effects because they fear they will be taken off immunotherapy.  Sometimes a pause in treatment might be necessary, but the earlier the oncologist is made aware of a side effect, the less likely that will be necessary.

In addition, patients undergoing immunotherapy should always take the name(s) of their immunotherapy drugs and the name of their oncologist when seeing medical professionals outside of their cancer treatment team. This is especially important when visiting the ER.  Because immunotherapy drugs are newer and highly targeted to certain cancers, many medical professionals remain unfamiliar with drug interactions and treating related side effects.

Immunotherapy On The Rise

Immunotherapy treatments have resulted in reports of remission in cases that would’ve been deemed hopeless just five or 10 years ago.  The Federal Drug Administration (FDA) has approved various immunotherapy treatments for melanoma, lung cancer, head and neck cancer, bladder cancer, cervical cancer, liver cancer, stomach cancer, lymphoma, breast cancer, and most recently bladder cancer.  (Here is a list of  immunotherapies by cancer type from the Cancer Research Institute.)

“It’s revolutionized how we treat our patients,” says Dr. Gainor of Mass General about immunotherapy’s impact on lung and esophageal cancer.

Advances in immunotherapy research and trials continue to generate optimism and excitement. A clinical study in Houston is looking at using immunotherapy to prevent a recurrence. Researchers in Britain recently announced a discovery that might lead to advances in immunotherapy treatments to a much broader array of cancers.

While there is excitement around the field of immunotherapy and it has resulted in unprecedented success in treating some previously hard-to-treat cancers, it remains an option for a minority of cancer diagnoses.  It works best on solid tumors with more mutations, often referred to as having a high-mutational load or microsatellite instability (MSI) high. And it is not universally successful for every patient.

With hundreds of clinical trials involving immunotherapy alone or in combination with other therapies, it is certain more treatment options are on the horizon. As more therapies are developed and more patients with a greater variety of conditions undergo immunotherapy, we will also increase our understanding of potential side effects.

Side effects should not dissuade patients and care partners from considering immunotherapy if it is available or from advocating for genetic tests to deteimine if it is an option. Many patients undergoing immunotherapy have previously undergone chemotherapy and report that the side effects are fewer and milder by comparison.  The important thing is that patients and their partners know what to expect and communicate with their treatment team.

If the next 10 years in immunotherapy research and development are anything link eth elast 10, we can expect more exciting advancements in the battle against cancer. For more perspective on what’s ahead for immunotherapy see the Cancer Research Institute’s article: Cancer Immunotherapy in 2020 and Beyond.

Understanding Clinical Trials: A Jargon Buster Guide

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When it comes to cancer treatment you or a loved one may be considering participating in a clinical trial as a treatment option.  Clinical trials are designed to evaluate the safety and effectiveness of a treatment. They may involve researchers administering drugs, taking blood or tissue samples, or checking the progress of patients as they take a treatment according to a study’s protocol.

Learning about clinical trials can be a steep learning curve – not least because the process comes with a lot of new terms, acronyms and jargon.  To help you, I’ve put together this list of the most common terms you will find when you are researching clinical trial information. This is not an exhaustive list but it is a helpful starting point. At the end of this article you will see links to find more information.

Adverse Effects (AE)

Also called Adverse Events, or Adverse Drug Reaction, AEs are any harmful event experienced by a person while they are having a drug or any other treatment or intervention. In clinical trials, researchers must always report adverse events, regardless of whether or not the event is suspected to be related to or caused by the drug, treatment or intervention.

Arm

Subsection of people within a study who have a particular intervention.

Bias

Bias is an error that distorts the objectivity of a study. It can arise if a researcher doesn’t adhere to rigorous standards in designing the study, selecting the subjects, administering the treatments, analysing the data, or reporting and interpreting the study results. It can also result from circumstances beyond a researcher’s control, as when there is an uneven distribution of some characteristic between groups as a result of randomization.

Blinding

Blinding is a method of controlling for bias in a study by ensuring that those involved are unable to tell if they are in an intervention or control group so they cannot influence the results. In a single-blind study, patients do not know whether they are receiving the active drug or a placebo. In a double-blind study, neither the patients nor the persons administering the treatments know which patients are receiving the active drug. In a triple-blind study, the patients, clinicians/researchers and the persons evaluating the results do not know which treatment patients had. Whenever blinding is used, there will always be a method in which the treatment can be unblinded in the event that information is required for safety.

Comparator

When a treatment for a specific medical condition already exists, it would be unethical to do a randomized controlled trial that would require some participants to be given an ineffective substitute. In this case, new treatments are tested against the best existing treatment, (i.e. a comparator). The comparator can also be no intervention (for example, best supportive care).

Completed

A trial is considered completed when trial participants are no longer being examined or treated (i.e. no longer in follow-up); the database has been ‘locked’ and records have been archived.

Control

A group of people in a study who do not have the intervention or test being studied. Instead, they may have the standard intervention (sometimes called ‘usual care’) or a dummy intervention (placebo). The results for the control group are compared with those for a group having the intervention being tested. The aim is to check for any differences. The people in the control group should be as similar as possible to those in the intervention group, to make it as easy as possible to detect any effects due to the intervention.

Efficacy

How beneficial a treatment is under ideal conditions (for example, in a laboratory), compared with doing nothing or opting for another type of care. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed.

Eligibility Criteria/ Inclusion and Exclusion Criteria

Eligibility criteria ensures patients enrolling in a clinical trial share similar characteristics (e.g. gender, age, medications, disease type and status) so that the results of the study are more likely due to the treatment received rather than other factors.

Follow-up

Observation over a period of time of participants enrolled in a trial to observe changes in health status.

Informed Consent

A process (by means of a written informed consent form) by which a participant voluntarily agrees to take part in a trial, having been informed of the possible benefits, risks and side effects associated with participating in the study.

Intervention

The treatment (e.g., a drug, surgical procedure, or diagnostic test) being researched. The intervention group consists of the study participants that have been randomly assigned to receive the treatment.

Investigator

A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator (PI).

Multicentre Trial

A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.

Number needed to treat (NNT)

The average number of patients who need to receive the treatment or other intervention for one of them to get the positive outcome in the time specified.

Outcome Measures

The impact that a test, treatment, or other intervention has on a person, group or population.

Phase I, II, III and IV Studies

Once the safety of a new drug has been demonstrated in tests on animals, it goes through a multi-phase testing process to determine its safety and efficacy in treating human patients. If a drug shows success in one phase, the evaluation moves to the next phase

  • Phase 1 tests a drug on a very small number of healthy volunteers to establish overall safety, identify side effects, and determine the dose levels that are safe and tolerable for humans.
  • Phase II trials test a drug on a small number of people who have the condition the drug is designed to treat. These trials are done to establish what dose range is most effective, and to observe any safety concerns that might arise.
  • Phase III trials test a drug on a large number of people who have the condition the drug is designed to treat. Successful completion of Phase III is the point where the drug is considered ready to be marketed.
  • Phase IV trials can investigate uses of the drug for other conditions, on a broader patient base or for longer term use.

Placebo

A fake (or dummy) treatment given to patients in the control group of a clinical trial.  Placebos are indistinguishable from the actual treatment and used so that the subjects in the control group are unable to tell who is receiving the active drug or treatment. Using placebos prevents bias in judging the effects of the medical intervention being tested.

Population

A group of people with a common link, such as the same medical condition or living in the same area or sharing the same characteristics. The population for a clinical trial is all the people the test or treatment is designed to help.

Protocol

A plan or set of steps that defines how something will be done. Before carrying out a research study, for example, the research protocol sets out what question is to be answered and how information will be collected and analysed.

Randomized Controlled Trial (RCT)

A study in which a number of similar people are randomly assigned to 2 (or more) groups to test a specific drug, treatment or other intervention. One group has the intervention being tested; the other (the comparison or control group) has an alternative intervention, a placebo, or no intervention at all. Participants are assigned to different groups without taking any similarities or differences between them into account. For example, it could involve using a computer-generated random sequence. RCTs are considered the most unbiased way of assessing the outcome of an intervention because each individual has the same chance of having the intervention.

Reliability

The ability to get the same or similar result each time a study is repeated with a different population or group.

Sample

People in a study recruited from part of the study’s target population. If they are recruited in an unbiased way, the results from the sample can be generalised to the target population as a whole.

Subjects

In clinical trials, the people selected to take part are called subjects. The term applies to both those participants receiving the treatment being investigated and to those receiving a placebo or alternate treatment.

Trial Site

The location where trial-related activities are conducted.

References

The Canadian Institutes of Health Research (CIHR)

TROG Cancer Research

ICH.org

NICE

Further Resources

American Society of Clinical Oncology’s Cancer.Net trials site

National Cancer Institute (NCI) Clinical Trials lists open and closed cancer clinical trials sponsored or supported by NCI. 

ClinicalTrials.gov database of privately and publicly funded clinical studies

CenterWatch Clinical Trials Listing

Beyond Pink: The Other Side of Breast Cancer Awareness and Lessons We’ve Learned From Each Other

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It’s October and the pink frenzy is in full force.  Breast Cancer Awareness Month (BCAM) is impossible to miss given the pink ribbon avalanche that arrives each Fall.  While there is no denying that BCAM has played a significant role over the past two decades in raising public awareness of breast cancer, there is  nevertheless growing criticism of its off-balance approach to awareness-raising, with many key messages becoming lost in a sea of “pink-washing.”  Interestingly, some studies have even found that pink branding may actually lead the public to take breast cancer less seriously.

“The biggest issue I have with Breast Cancer Awareness month is that it’s not even really awareness,” writes Elizabeth McKenzie, who was diagnosed with breast cancer in 2012. “Awareness is mindfulness of all aspects of breast cancer, which to a certain respect, is different for all of us, based on medical differences in disease processes, treatment access, and personal, social-emotional and cognitive processes.”

Much of the criticism centers on breast cancer campaigns which over-sexualise the disease, equating breasts with womanhood and femininity. Rod Ritchie, who was diagnosed with breast cancer in 2014, points out that “October is a bad time for male breast cancer survivors because the trivialisation and sexualisation of the disease by the pink charities reinforces public awareness that breast cancer is gender specific. Since there’s little attempt to educate men that they need to be aware of symptoms too, we are diagnosed later and have a poorer prognosis. So, how about adding some blue to the pink, encouraging research on us, and screening those with a genetic propensity?”

Over a decade ago on an October morning, I was diagnosed with breast cancer; a double reminder each year of the role this disease has played in my own life.   Looking back, I now see that my view of breast cancer was one-dimensional. Standing today on this other side of cancer I see a broader picture, a richer landscape of many shades beyond pink. This post is intended to provide a truer picture of the lives of breast cancer patients in its many varied hues.  Wherever you are in your experience, whether you are caring for a loved one, recently diagnosed, finished treatment, or living with a recurrence or metastatic cancer, I hope this post will speak to you.

Lessons We’ve Learned From Each Other

Some of the most valuable lessons I’ve learned about breast cancer have come, not from my doctors, but from fellow patients. My doctors didn’t tell me about the effect of chemotherapy on my future fertility. I didn’t learn that treatment could damage my heart. And I finished treatment with no clue about late treatment side-effects or the risk of a cancer recurrence.

While valuing her oncologist’s expertise, Catherine Foy, who blogs at My Triple Negative Life, acknowledges that “within the online breast cancer community there will be someone awake somewhere in the world that can provide support and advice. For example, based on someone I followed I got my Vitamin D level checked which was very low and I am now on supplements. Other examples include creating awareness of late treatment side effects and reducing the feelings of isolation that some may experience.”

Liz O’Riordan, a breast surgeon diagnosed with recurrent breast cancer, and co-author of The Complete Guide to Breast Cancer, also refers to the feelings of isolation she experienced during her treatment. “I felt incredibly alone during my breast cancer treatment. I didn’t meet another patient at any of my chemo or radiotherapy sessions. All my advice was from amazing people on Twitter,” she says.  Liz offers this advice to patients undergoing chemotherapy:  “The two best tips I was given to reduce the side effects of chemo were: (1) Drink. Lots. Even when it taste disgusting. Ideally 3 litres a day. Try flavoured water or cordial. Carry a bottle everywhere you go. (2) Exercise. Walk for 30 minutes every day. You’ll hate me for making you. Some days you may have to stop and spit and pant and retch. But do it. You will feel better for it. And they were right. I did feel better.”

Barbara Jacoby of Let Life Happen agrees that we can learn valuable coping lessons from each other. “Whether it is a question of side effects that one is experiencing from a prescribed medication, or questions regarding treatment options or experiences or procedures, if you query a patient support or advocacy group, you are likely to find more answers and information from those who have had actual personal experiences with these issues. There is no doctor or group of medical professionals that has all of the information about real patient experiences and outcomes like any group of actual patients who have dealt with just about anything and everything imaginable on every level,” she says.

Both Catherine and Barbara believe that the information you get online should be shared and discussed with your doctors as the basis of shared decision making (the conversation that happens between a patient and clinician to reach a healthcare choice together).  “I value my oncologist’s advice and experience,” says Catherine, “and would usually discuss with him any new developments that I may have encountered through the various platforms on social media.”

Terri Coutee, a two-time breast cancer survivor, and founder of DiepCFoundation, a non-profit organization providing information on options for breast reconstruction after mastectomy, also embraces the concept of shared decision making and wants others to experience it too.  “I have had chemotherapy, radiation, two lumpectomies, a double mastectomy and breast reconstruction using my own tissue,” she says. ”Each of these occurrences was fraught with difficult decisions and hours of research to optimize my own health care plan. I left offices of various health care providers with armfuls of brochures and information to sort through and organize.”

Terri encourages patients to download the Breast Advocate App, a new tool to aid the shared decision making process.  The app was developed by plastic surgeon Dr Minas Chrysopoulo, whose patient population is primarily those affected by breast cancer or at high risk of developing breast cancer. “Shared decision making is an extremely powerful approach to deciding our treatment plans. Simply put, it empowers us and helps us advocate for ourselves,” explains Terri.  “As patients, we owe it to ourselves to embrace everyday conversations with our health care teams,” she says. “The information on the Breast Advocate app is informative, intuitive, and specific to your individual diagnosis or situation. There are treatment options with evidence-based articles to discuss with your healthcare team. It even features a community section. I encourage you to check out the wealth of shared decision-making information and download the Breast Advocate app to your phone.”

Siobhan Freeney, founder of Being Dense, an organization which raises awareness of Breast Density and its associated links to breast cancer and screening, was completely unaware of the issue until she was diagnosed with breast cancer. “40% of women have Dense Breasts,” she explains. “A Mammogram is the only way to determine and measure Breast Density.  In Dense Breasts the reliability of screening mammograms can be reduced by as much as 50%.”   When you have a Mammogram, the radiologist reading it can tell if you have Dense Breasts.  Siobhan recommends you should ask for a copy of your radiology Mammogram report and ask if your breasts are dense. “If you have Dense Breasts you need to know and you should ask your Doctor/Radiologist about more personalised screening such as Breast Ultrasound or MRI,” she advises.

Metastatic Breast Cancer: The Other Side of BCAM

Learning about metastatic breast cancer (MBC; also called stage 4, secondary, or advanced breast cancer) from online blogs and social media networks was revelatory for me. MBC is breast cancer that has spread beyond the breast — to the bones, liver, brain, or another organ. Even if the cancer is found in another organ, it’s still referred to as breast cancer. Like Beth Gainer, who says, she learned “that anyone who’s been diagnosed with breast cancer is at risk,” I too have found, in Beth’s words, “what the metastatic breast cancer community has had to say has been a real eye-opener.”

MBC has been referred to as a story half-told, the other side of BCAM we don’t hear enough about. As Catherine points out, “For me, breast cancer awareness month is for those who are not yet diagnosed or those newly diagnosed. The pink scene looks to future research and provides good information for those starting or in the midst of treatment. There is less focus on those of us living or dying with breast cancer.”

Nancy Stordahl is unequivocal in her criticism of the failure each October to adequately raise awareness of MBC. “Despite all the pink, all the races, all the pink ribbons, most people still know little or nothing about metastatic breast cancer,” she writes. “No wonder so many with metastatic breast cancer feel left out, isolated, alone and yes, even erased.”

Joanne Taylor, a metastatic breast cancer patient and advocate, is pushing for more information and awareness of MBC.  She created this infographic to show the red flag symptoms of advanced breast cancer.

While metastatic breast cancer is terminal and cannot be cured, because of improved treatments more women are living longer than ever with it. Even so, many misconceptions and lack of information about this diagnosis persist.    “A stranger called Elizabeth Richards contacted me and like many other women she knew very little about MBC, yet the more she found out, the more angry and amazed she became that the illness was side-lined,” says Joanne. “Elizabeth’s view was that as long as metastatic cancer wasn’t mainstream people would not be aware of the limited treatment options available to them. If they knew, they’d demand more.”

One of the biggest misconceptions is that MBC is an instant death sentence. “We thought with BCAM coming up we would do something different to show how people could live well with MBC, so we started the #busylivingwithmets campaign,” explains Joanne. “Elizabeth had the idea, it was positive, it showed what people can do if they have access to drugs and surgery. I was her inspiration! If I can do it, others can as well – if they are given the right options.”

Lessons of Resilience, Connection, and Hope

Cancer can be a lonely and isolating experience, but it doesn’t have to be. “A friend told me to accept whatever help was offered, says breast cancer survivor Connie Rosser Riddle. “It was her way of saying to quit being Superwoman, that it was okay to be in need, vulnerable. It was best to be specific when folks asked, “What can I do for you?” My answer combined what that person was best at and where I needed help, and that made a good fit for both of us.”

Audrey Birt, diagnosed with breast cancer three times, shares lessons of courage, connection and resilience on her blog.  “Cancer taught me I’m more resilient than I would have believed, it helped make me braver,” she says. “It also taught me that life cannot be controlled. This made me more able to live in the moment, and for the moment.  That’s probably not so good for my bank balance but it’s great for my life balance in a way. It taught me to reengage with writing through my blog and in a funny way it changed my life and connection to others. But it also taught me my fragility and that’s a lesson I’m still learning, one day at a time.”

Ultimately however, the lessons you learn will be unique to you. “There is not a single person, story, book, lecture or talk, which will teach us all we need to know to understand the impact of cancer on our lives. That’s what we have to figure out for ourselves when we go through our own cancer experience,” says therapist, Karin Sieger . “Having been diagnosed twice with breast cancer all I can say is try and stay open minded – to your body, the illness, treatment options. You always have choices. Don’t get stuck in fear and don’t get stuck in complacency either. Live your life to the best of your ability and stay true to who you are – with or without cancer.”