General Health Info Archives
Cancer is a broad category of diseases characterized by abnormal and uncontrolled cell growth. There are more than 100 types of cancers and the disease can occur almost anywhere in the body. More than a million people are diagnosed each year in the United States with some form of cancer. Millions more find themselves in the role of care partner or advocate. If you are one of them, do not be overwhelmed.
More resources for General Health Info from Patient Empowerment Network.
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.
Subsection of people within a study who have a particular intervention.
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 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.
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).
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.
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.
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.
Observation over a period of time of participants enrolled in a trial to observe changes in health status.
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.
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.
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).
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.
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.
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.
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.
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.
The ability to get the same or similar result each time a study is repeated with a different population or group.
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.
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.
The location where trial-related activities are conducted.
A Stanford Medicine X e-Patient scholar, Marie Ennis O’Connor is an internationally recognized keynote speaker, writer, and consultant on global trends in patient engagement, digital health and participatory medicine. A board member of the Patient Empowerment Foundation, a network of people, foundations, organizations and medical institutions dedicated to empowering patients worldwide, Marie’s work is informed by her passion for embedding the patient voice at the heart of healthcare values. She writes about the experience of transitioning from breast cancer patient to advocate on her award-winning blog Journeying Beyond Breast Cancer.
Suja JohnkuttyHi there ! I’m Suja Johnkutty, MD a conscientious mom and neurologist . My one simple goal is to provide you honest, practical, simple action steps to experience better relaxation in your life. https://betterrelaxation.com
Hi there ! I’m Suja Johnkutty, MD a conscientious mom and neurologist . My one simple goal is to provide you honest, practical, simple action steps to experience better relaxation in your life.
As patients, we normally rely on our doctors to tell us which tests and medications to take for the betterment of our health. Rarely do we question them since they know a whole lot more than most of us when it comes to medical ailments and overall health. However, that doesn’t mean you can’t find out more about the various suggestions doctors make.
If you have an ailment in the body and your doctor finds it hard to determine exactly what it is, they will likely ask you to get either a CT scan or MRI done. The tests are used to provide a detailed view of your internal body to help determine the ailment. We breakdown the two for your better understanding:
CT scans provide imaging using x-rays at different angles. This scan is more in-depth as compared to an x-ray. X-ray tests use a beam of radiation from a set angle and display the image. Since a CT scan uses a series of radiation beams at different angles, it slices the same image up, giving a 3D view so doctors can understand the ailment better. With the help of a computer, an image is produced. CT scans can help determine ailments such as cancer, bone injuries, and chest and lung ailments.
Magnetic resonance imaging (MRI) uses a magnetic field instead of radiation and provides a more detailed image of the body which also includes soft tissues along with the internal body. It is used to help diagnose the following:
- Brain injury
- Damaged blood vessels
- Spinal cord injury
- Multiple sclerosis
- Bone infections
- Damaged joints
- It can also be used to ensure that various organs are healthy.
Both methods are noninvasive and rely on heavy technology. But when it comes to CT scans, more and more hospitals are opting for mobile CT scanners, which make it easier for them to manage.
Getting Ready for the Test
Preparing for CT Scan and MRI is slightly different. With CT scans, your doctor may recommend you take a contest dye. The dye helps highlight the scanned region more and is generally consumed when scanning the abdomen. It is important to notify your doctor if you have any allergies because you may react to the dye. If you’ve previously had reactions to prednisone (a steroid), iodine, or seafood then the doctor should be immediately notified. Other than that, the doctor may ask you not to drink or eat several hours before the test.
For an MRI, the one thing you need to make sure is that you are not wearing anything that can be detected by magnets. This means, no jewelry, watches, hearing aids, glasses, and other items that may have a metal can be worn during the test. In some cases, a gadolinium dye may be recommended which is injected into the hand or arm. The dye highlights certain details in the imaging and rarely results in any type of reaction. The test can be lengthy for some as it takes anywhere from 30-45 minutes, so if you are claustrophobic, you may want to discuss that with your doctor since you are required to stay in a closed space for that period.
- CT Scan: You will be asked to put on a robe and remove jewelry and other metal objects so they don’t have any impact on the image produced. The scanner itself is a doughnut-shaped machine and you lie on a flat table in the middle. The table starts to move back and forth and x-ray tubes fitted into the scanner send out beams and different angles. They pass through your body to the other end of the scanner. The test is painless but make sure you are comfortable because you will be asked to stay still as the scan is going on.
- MRI: The MRI machine is a long narrow tube that is open at both ends. Like in a CT scan, you lie down on a flat movable table that slides into the tube. As you slide in, the table stops at the specific part of the body being examined and a magnetic field is created and radio waves are directed to the body. The machine does make tapping and thumping noises, so the technician will likely offer earplugs to block it out.
Understanding the Test Result
After getting either a CT scan or MRI done, you will need to consult your doctor. Unless you are a trained doctor, the images will make little to no sense to you. You will need to consult a radiologist that can explain the results to you. In case of an ailment, they will usually recommend you consult a specialist, depending on the ailment, that can assist you further.
As a patient, it is important for you to understand the tests and treatment doctors recommend. Most of the time, you can consult your doctor and they will be more than willing to give you the information you need. Knowing makes it easier for you to undergo the tests and treatments with a little more ease.
Scott has been working in the radiology field for over 30 years. He finds the biological phenomenons found in humankind fascinating and appreciates the incredible use that diagnostic imagery has to save lives. Other than acting as the President for Catalina Imaging, Scott enjoys spreading the word on new insights and breakthroughs in the radiology field, specifically the impact that mobile imaging has for patient care.
This podcast was originally published by Cornell Weill Cancer Cast, on March 22, 2019, here.
This podcast was originally by Five to Thrive on January 17, 2019, here.
Most people harbor some amount of fear about getting diagnosed with cancer. For those who are successfully treated for cancer to the point where they no longer have the disease, the fear of recurrence can be tremendous and significantly debilitating to one’s wellness. How can cancer survivors overcome this fear? Can cancer survivors live a fearless life after cancer? Let’s find out… This show is broadcast live on Tuesday’s at 7PM ET on W4CS – The Cancer Support Network (www.w4cs.com) part of Talk 4 Radio (http://www.talk4radio.com/) on the Talk 4 Media Network (http://www.talk4media.com/).
This podcast was originally published by the We Have Cancer show by on March 5, 2019, here.
In our first episode supporting 2019 Colon Cancer Awareness Month, Carole Motycka talks about how advocacy and faith has helped her far outlive her doctor’s initial prognosis.
During this interview we talked about:
- How a minor hiking accident led to her diagnosis of stage 4 colon cancer and Juvenile Polyposis Syndrome (JPS).
- Her doctors giving her a 6-11 month prognosis, three years ago.
- The treatment and support she received from the Cleveland Clinic.
- Why she needed a liver transplant after doctors finding No Evidence of Disease.
- How a liver donor was found and her relationship with this fellow church member.
- The role her faith played in her diagnosis, recovery and her life going forward.
Connect With Carole
This podcast was originally published by The Cancer Cast by Jennifer Levine here.
- Fertility preservation options for men and women with cancer.
Guest: Jennifer Levine, MD, pediatric hematologist-oncologist at Weill Cornell Medicine and NewYork-Presbyterian Hospital.
Host: John Leonard, MD, world-renowned hematologist and medical oncologist at Weill Cornell Medicine and NewYork-Presbyterian Hospital.
This podcast was originally published by NPR’s Joy of Medicine here.
This blog was originally published by Cancer Today by Cheryl Platzman Weinstock, here.
by Cheryl Platzman Weinstock
PEOPLE WHO HAVE BEEN DIAGNOSED with cancer often face sleep problems stemming from the physical effects of cancer treatment as well as psychological or spiritual concerns related to the diagnosis.
A randomized clinical trial published April 9, 2019, in the Journal of the National Cancer Institute compared cognitive behavioral therapy for insomnia (CBTi) and acupuncture in patients who had completed treatment for a variety of cancers. Study results showed that participants assigned to the CBTi group experienced a greater reduction in insomnia severity over the course of the study compared with the acupuncture group. However, survivors treated with acupuncture also experienced meaningful improvement in their sleep.
The researchers assigned 80 patients to receive CBTi from therapists trained in the technique over the course of eight weeks. CBTi has previously been shown to be effective in improving sleep in cancer survivors. The therapy works in part by modifying unhelpful beliefs about sleep and providing relaxation training. Patients are also asked to limit their time in bed and use it only for sleep and sexual activity. Another 80 patients were assigned to receive acupuncture over the course of eight weeks. Participants in the study were 62 years old, on average, and had completed active cancer treatment.
The researchers asked the participants to fill out a questionnaire asking about insomnia symptoms both before and after receiving treatment for insomnia. Patients reported significant improvements after receiving either CBTi or acupuncture, both when surveyed immediately after their course of treatment for insomnia and about three months later.
“While overall we found that there is a statistically significant benefit of CBTi over acupuncture, the difference is actually small,” says Jun Mao, chief of integrative medicine at Memorial Sloan Kettering Cancer Center in New York City, who led the study. “I certainly think both treatments produce clinically meaningful outcomes and they persist.”
When they looked more closely at subgroups of patients, Mao and his research team found that CBTi was only significantly better than acupuncture at reducing insomnia for males, white people, people who had graduated from college and people without significant pain. For other groups, the two treatments had a similar effect.
Poor sleep can have a variety of effects, including increased pain, depression and fatigue, says Sandra Mitchell, a research scientist and program director in the Outcomes Research Branch at the National Cancer Institute in Rockville, Maryland, who was not involved in the study.
Although Mitchell says she believes additional studies are needed to look at the long-term effects of acupuncture and CBTi management, she says, “This study yields important and clinically actionable results that patients and providers can utilize in a shared decision-making approach.”
Weidong Lu, lead oncology acupuncturist at Dana-Farber Cancer Institute in Boston, says today many patients with insomnia are first put on medications, which can cause side effects. “I think it’s best starting patients on nonpharmaceuticals for mild- and moderate-level insomnia. Severe, long-term insomnia probably needs a combination approach” that includes drugs and other therapies, such as acupuncture and CBT, says Lu, who was also not involved in the study.
The trial was supported in part by the Patient-Centered Outcomes Research Institute (PCORI), a nongovernmental organization funded through a trust established by the Affordable Care Act to carry out research guided by patients and caregivers.
Jodi MacLeod of Collegeville, Pennsylvania, was one of the patient partners who provided input into the design and execution of the clinical trial. She was diagnosed with stage II breast cancer in 2004.
After treatment, “the expectation was that I would return to being a normal stay-at-home mom, but my insomnia was really disruptive,” she recalls. Her sleep problems led to mental fog and fatigue. Eventually, MacLeod’s husband rearranged his work schedule to help take care of their three young children.
“Back then, in 2005, insomnia and cancer wasn’t well researched and recognized. I actually thought it was my fault,” says MacLeod of her difficulty in sleeping.
MacLeod met Mao in 2006 when she enrolled in a study he was conducting at the University of Pennsylvania in Philadelphia on acupuncture and cancer-related joint pain. When Mao was ready to do his PCORI-funded research on cancer and sleep, he reached out to MacLeod for her help.
Among other contributions, MacLeod and her fellow patient advisers helped decide what questions the study would seek to answer, shape inclusion and exclusion criteria for the trial and recruit a diverse group of patients to participate, as described in a 2017 paper that MacLeod co-authored.
“It is satisfying and empowering to know that we’re leaving the cancer waiting room better than we found it,” says MacLeod. “Cancer patients now don’t have to go through what I did, because now there are effective insomnia treatments available.”
This blog was originally published by I Had Cancer.com on July 23, 2019, by Catherine, here.
This month marks the five year anniversary of my first cancer diagnosis, and three years since my stage IV diagnosis. Statistics say that I’m at the upper limit of my predicted survival (2-3 years), so it looks like I’m bucking the trend. I have a strange mixture of emotions. On one hand I feel like celebrating, but on the other hand I feel quite drained – emotionally and physically. It’s hard work living with cancer.
I’m tired of traveling to Manchester every three weeks for treatment. I’m sick of feeling guilty when I eat a dessert or drink one too many glasses of wine. I’ve had enough of slathering on cream to try to keep the skin on my hands and feet from cracking. I’m fed up with scans, blood tests, cannulas, and putting up with the indignity of being poked and prodded by strangers. What I wouldn’t give for just a few months of freedom from the shackles and restraints that my cancer diagnosis entails.
Recent years have seen a huge rise in cancer life expectancy. Medical advances in immunotherapy, genetic profiling, artificial intelligence and advanced imaging are just a few of the areas that are significantly impacting that survival rate. It is now estimated that 2.5 million people in the UK alone are living with cancer and over 15 million in the US.
Despite this growing population, there is so little awareness and understanding of advanced-stage cancer and its emotional and physical burden. I’ve lost count of the number of times I’ve been asked when my treatment will be finished. When I explain that I’ll be on treatment forever, people look shocked and embarrassed. There is a general perception that cancer is something you have, and if you’ve caught it early and fight hard enough, you beat it. Versions of this story are churned out with every awareness campaign, accompanied by coloured ribbons and sponsored runs.
I’m not saying that we should stop these campaigns – it is important to highlight the symptoms of cancer and encourage people to be vigilant – but society needs to become aware of the daily challenges people living with cancer face in our attempt to live a ‘normal’ life.
Most of us will be on treatment forever – treatment that often comes with debilitating side effects. Many of us are unable to work, or are struggling through pain and fatigue to hold down a job so that we can afford to feed and clothe our children. Normal life plays second fiddle to the endless cycle of medical appointments. And every single one of us has a constant mental battle to overcome the fear of an uncertain future.
I’m exceptionally grateful that, five years on from my original diagnosis, I’m still here and relatively healthy. But it is exhausting having to keep conjuring up the inner strength to overcome the physical and emotional daily challenges of a cancer diagnosis for such a long period of time.
Sorry for the moan, it’s quite out of character. I’m usually a proud person, preferring to keep my struggles and insecurities private, but I feel quite strongly that there is simply not enough understanding or practical support for the millions of people in this country and around the world in my position.
Globally we are making huge advances in our ability to kill off errant cancer cells, but we have long neglected the wider emotional, physical and financial needs of the people whose lives we’re extending.
I long for a time when society has a better appreciation of the challenges cancer survivors face and can start creating an environment that better supports the needs of our growing population.
This resource was originally published by National Coalition For Cancer Survivorship here.
Despite the widespread nature of the disease, primary care physicians and other health care providers are often unfamiliar with survivorship issues and do not generally receive formal guidance from oncologists on how to monitor cancer survivors or manage their care.
Below are articles and resources to assist cancer survivors and their families and caregivers with issues that arise post-treatment.
This resource was originally published by National Coalition For Cancer Survivorship here.
This resource was originally published by Cancer Today Mag.com by Bob Riter, Monica Vakiner and Carole Baas, here.
by Bob Riter, Monica Vakiner and Carole Baas
WHILE IT’S MOST COMMON to hear about cancer patients getting involved in research by enrolling in clinical trials, patients and others affected by cancer can also help shape the direction of research by serving on scientific review panels.
These panels bring together experts to analyze research proposals to help determine which ideas will receive funding. Several organizations and government programs, including the Congressionally Directed Medical Research Programs, the Patient-Centered Outcomes Research Institute and Susan G. Komen, provide opportunities for grant review to patient advocates, including cancer survivors, patients and caregivers.
Opportunities to Apply Yourself
Advocates interested in becoming involved in a research review panel can explore options with government agencies and nonprofit organizations, including patient advocacy organizations that provide research funding for various projects.
- Funding organizations such as the Congressionally Directed Medical Research Programs and the Patient-Centered Outcomes Research Institute allow advocates to apply online to serve as reviewers.
- Intensive training programs such as the American Association for Cancer Research Scientist↔Survivor Program or the National Breast Cancer Coalition Project LEAD help advocates learn more about the science of cancer.
- The Cancer Information Support Network, Cochrane Training and Research Advocacy Network offer online learning opportunities for patient advocates who want to learn more about interpreting research.
While scientists and clinicians on panels analyze the science, patient advocates judge the merit of the study from a more personal vantage point, guided by a basic question: “Will the study make a difference in the lives of patients?” Everyone on the panel has an equal voice and vote to rank the research applications.
Advocates who are selected to be a part of a scientific review panel usually participate in an introductory phone call or webinar hosted by the panel organizers, who provide an overview of the process and answer any questions. Some review panels pair novice patient advocates with experienced advocate mentors. In these cases, novices can connect with and get feedback from their mentors.
Scientific review panels typically have a mix of approximately 20 scientists and two to four advocates. While each panel has its own process for review depending on the funding organization, panelists typically review approximately five to 10 research proposals, providing comments and scores. These research proposals generally include sections that describe the research plan, the researchers’ qualifications, a timeline, a budget and letters of support from the organizations where the researchers work.
Advocates are not expected to understand each scientific detail in these proposals. Rather, they focus on the potential impact of the research on the patient community. For example, advocates are well suited to offer feedback on the lay abstract, the one-page overview of the proposal written in nontechnical language. These abstracts provide a general idea of the research and demonstrate the researchers’ ability to communicate with a broader audience.
In addition, patient advocates can ask several important questions about the research: Does the grant application have a clear hypothesis? Does the researcher make a compelling case that the research is important? Do the researchers and institutions where they work have track records that demonstrate the research will be completed? Do the letters of support indicating institutional backing seem enthusiastic?
Optimize Your Time
Follow these practical tips to make an impact on scientific review panels.
Further CollaborationOnce the initial scoring is tabulated, panelists meet again—either virtually or in person. For example, the Congressionally Directed Medical Research Programs hold meetings for one to two days in the Washington, D.C., area. During the meeting, each panel reviews the top-scoring 20 to 30 applications in its assigned subject area.
The committee chair and a scientific review officer keep the panel focused and on schedule. The reviewers go over their rationales for scoring decisions for the proposals they initially reviewed. After discussion, panelists score each proposal.
The proposals are then rank-ordered based on the scoring and often referred to a different committee (commonly known as a program committee or integration panel) for final funding decisions. This committee takes a broad view and makes sure that awards are consistent with criteria outlined in the call for grant proposals. A few months later, the grant awards are typically announced on the funding organization’s website.
Serving on a scientific review panel allows advocates to influence the direction of research and to learn from—and become friends with—esteemed researchers and clinicians. Including advocates as collaborators with scientists and clinicians provides a wonderful synergy, reminding all parties involved that, in addition to being a disease that affects cells, cancer is also a disease that affects people.