Cancer Prevention Overview (PDQ®)–Patient Version

Cancer researcher SCOR NCORPCancer prevention is action taken to lower the chance of getting cancer. In 2020, more than 1.8 million people will be diagnosed with cancer in the United States. In addition to the physical problems and emotional distress caused by cancer, the high costs of care are also a burden to patients, their families, and to the public. By preventing cancer, the number of new cases of cancer is lowered. Hopefully, this will reduce the burden of cancer and lower the number of deaths caused by cancer.

Cancer is not a single disease but a group of related diseases. Many things in our genes, our lifestyle, and the environment around us may increase or decrease our risk of getting cancer.

Scientists are studying many different ways to help prevent cancer, including the following:

  • Ways to avoid or control things known to cause cancer.
  • Changes in diet and lifestyle.
  • Finding precancerous conditions early. Precancerous conditions are conditions that may become cancer.
  • Chemoprevention (medicines to treat a precancerous condition or to keep cancer from starting).
  • Risk-reducing surgery.

Carcinogenesis

KEY POINTS

  • Carcinogenesis is the process in which normal cells turn into cancer cells.
  • Changes (mutations) in genes occur during carcinogenesis.

Carcinogenesis is the process in which normal cells turn into cancer cells.

Carcinogenesis is the series of steps that take place as a normal cell becomes a cancer cell. Cells are the smallest units of the body and they make up the body’s tissues. Each cell contains genes that guide the way the body grows, develops, and repairs itself. There are many genes that control whether a cell lives or dies, divides (multiplies), or takes on special functions, such as becoming a nerve cell or a muscle cell.

Changes (mutations) in genes occur during carcinogenesis.

Changes (mutations) in genes can cause normal controls in cells to break down. When this happens, cells do not die when they should and new cells are produced when the body does not need them. The buildup of extra cells may cause a mass (tumor) to form.

Tumors can be benign or malignant (cancerous). Malignant tumor cells invade nearby tissues and spread to other parts of the body. Benign tumor cells do not invade nearby tissues or spread.

Risk Factors

KEY POINTS

  • Factors That are Known to Increase the Risk of Cancer
    • Cigarette Smoking and Tobacco Use
    • Infections
    • Radiation
    • Immunosuppressive Medicines After Organ Transplant
  • Factors That May Affect the Risk of Cancer
    • Diet
    • Alcohol
    • Physical Activity
    • Obesity
    • Diabetes
    • Environmental Risk Factors

Scientists study risk factors and protective factors to find ways to prevent new cancers from starting. Anything that increases your chance of developing cancer is called a cancer risk factor; anything that decreases your chance of developing cancer is called a cancer protective factor.

Some risk factors for cancer can be avoided, but many cannot. For example, both smoking and inheriting certain genes are risk factors for some types of cancer, but only smoking can be avoided. Risk factors that a person can control are called modifiable risk factors.

Many other factors in our environment, diet, and lifestyle may cause or prevent cancer. This summary reviews only the major cancer risk factors and protective factors that can be controlled or changed to reduce the risk of cancer. Risk factors that are not described in the summary include certain sexual behaviors, the use of estrogen, and being exposed to certain substances at work or to certain chemicals.

Factors That are Known to Increase the Risk of Cancer

Cigarette Smoking and Tobacco Use

Tobacco use is strongly linked to an increased risk for many kinds of cancer. Smoking cigarettes is the leading cause of the following types of cancer:

  • Acute myelogenous leukemia (AML).
  • Bladder cancer.
  • Cervical cancer.
  • Esophageal cancer.
  • Kidney cancer.
  • Lung cancer.
  • Oral cavity cancer.
  • Pancreatic cancer.
  • Stomach cancer.

Not smoking or quitting smoking lowers the risk of getting cancer and dying from cancer. Scientists believe that cigarette smoking causes about 30% of all cancer deaths in the United States.

See the following PDQ summaries for more information:

Infections

Certain viruses and bacteria are able to cause cancer. Viruses and other infection-causing agents cause more cases of cancer in the developing world (about 1 in 4 cases of cancer) than in developed nations (less than 1 in 10 cases of cancer). Examples of cancer-causing viruses and bacteria include:

Two vaccines to prevent infection by cancer-causing agents have already been developed and approved by the U.S. Food and Drug Administration (FDA). One is a vaccine to prevent infection with hepatitis B virus. The other protects against infection with strains of human papillomavirus (HPV) that cause cervical cancer. Scientists continue to work on vaccines against infections that cause cancer.

See the following PDQ summaries for more information:

Radiation

Being exposed to radiation is a known cause of cancer. There are two main types of radiation linked with an increased risk for cancer:

Scientists believe that ionizing radiation causes leukemiathyroid cancer, and breast cancer in women. Ionizing radiation may also be linked to myeloma and cancers of the lungstomachcolonesophagusbladder, and ovary. Being exposed to radiation from diagnostic x-rays increases the risk of cancer in patients and x-ray technicians. Diagnostic radiation in children and adolescents has been linked with a higher risk of cancers at a young age.

The growing use of CT scans over the last 20 years has increased exposure to ionizing radiation. The risk of cancer also increases with the number of CT scans a patient has and the radiation dose used each time.

See the following PDQ summaries for more information:

Immunosuppressive Medicines After Organ Transplant

Immunosuppressive medicines are used after an organ has been transplanted from one person to another. These medicines stop an organ that has been transplanted from being rejected. These medicines decrease the body’s immune response to help keep the organ from being rejected. Immunosuppressive medicines are linked to an increased risk of cancer because they lower the body’s ability to keep cancer from forming. The risk of cancer, especially cancer caused by a virus, is higher in the first 6 months after organ transplant, but the risk lasts for many years.

Factors That May Affect the Risk of Cancer

Diet

The foods that you eat on a regular basis make up your diet. Diet is being studied as a risk factor for cancer. It is hard to study the effects of diet on cancer because a person’s diet includes foods that may protect against cancer and foods that may increase the risk of cancer.

It is also hard for people who take part in the studies to keep track of what they eat over a long period of time. This may explain why studies have different results about how diet affects the risk of cancer.

Some studies have shown that a diet high in fat, proteinscalories, and red meat increases the risk of colorectal cancer, but other studies have not shown this.

It is not known if a diet low in fat and high in fiber, fruits, and vegetables lowers the risk of colorectal cancer.

See the following PDQ summaries for more information:

Alcohol

Studies have shown that drinking alcohol is linked to an increased risk of the following types of cancers:

Drinking alcohol may also increase the risk of liver cancer and female colorectal cancer.

See the following PDQ summaries for more information:

Physical Activity

Studies show that people who are physically active have a lower risk of certain cancers than those who are not. It is not known if physical activity itself is the reason for this.

Studies show a strong link between physical activity and a lower risk of colorectal cancer. Some studies show that physical activity protects against postmenopausal breast cancer and endometrial cancer.

See the following PDQ summaries for more information:

Obesity

Studies show that obesity is linked to a higher risk of the following types of cancer:

  • Postmenopausal breast cancer.
  • Colorectal cancer.
  • Endometrial cancer.
  • Esophageal cancer.
  • Kidney cancer.
  • Pancreatic cancer.

Some studies show that obesity is also a risk factor for cancer of the gallbladder and liver cancer.

It is not known if losing weight lowers the risk of cancers that have been linked to obesity.

See the following PDQ summaries for more information:

Diabetes

Some studies show that having diabetes may slightly increase the risk of having the following types of cancer:

  • Bladder cancer.
  • Breast cancer in women.
  • Colorectal cancer.
  • Endometrial cancer.
  • Liver cancer.
  • Lung cancer.
  • Oral cancer.
  • Oropharyngeal cancer.
  • Ovarian cancer.
  • Pancreatic cancer.

Diabetes and cancer share some of the same risk factors. These risk factors include the following:

  • Being older.
  • Being obese.
  • Smoking.
  • Not eating a healthy diet.
  • Not exercising.

Because diabetes and cancer share these risk factors, it is hard to know whether the risk of cancer is increased more by diabetes or by these risk factors.

Studies are being done to see how medicine that is used to treat diabetes affects cancer risk.

Environmental Risk Factors

Being exposed to chemicals and other substances in the environment has been linked to some cancers:

  • Links between air pollution and cancer risk have been found. These include links between lung cancer and secondhand tobacco smoke, outdoor air pollution, and asbestos.
  • Drinking water that contains a large amount of arsenic has been linked to skin, bladder, and lung cancers.

Studies have been done to see if pesticides and other pollutants increase the risk of cancer. The results of those studies have been unclear because other factors can change the results of the studies.

Interventions That are Known to Lower Cancer Risk

KEY POINTS

  • Chemoprevention is being studied in patients who have a high risk of developing cancer.

An intervention is a treatment or action taken to prevent or treat disease, or improve health in other ways. Many studies are being done to find ways to keep cancer from starting or recurring (coming back).

Chemoprevention is being studied in patients who have a high risk of developing cancer.

Chemoprevention is the use of substances to lower the risk of cancer, or keep it from recurring. The substances may be natural or made in the laboratory. Some chemopreventive agents are tested in people who are at high risk for a certain type of cancer. The risk may be because of a precancerous conditionfamily history, or lifestyle factors.

Taking one of the following agents may lower the risk of cancer:

See the NCI website for more information about cancer prevention.

Interventions That Are Not Known to Lower Cancer Risk

KEY POINTS

  • Vitamin and dietary supplements have not been shown to prevent cancer.
  • New ways to prevent cancer are being studied in clinical trials.

Vitamin and dietary supplements have not been shown to prevent cancer.

An intervention is a treatment or action taken to prevent or treat disease, or improve health in other ways.

There is not enough proof that taking multivitamin and mineral supplements or single vitamins or minerals can prevent cancer. The following vitamins and mineral supplements have been studied, but have not been shown to lower the risk of cancer:

The Selenium and Vitamin E Cancer Prevention Trial (SELECT) found that vitamin E taken alone increased the risk of prostate cancer. The risk continued even after the men stopped taking vitamin E. Taking selenium with vitamin E or taking selenium alone did not increase the risk of prostate cancer.

Vitamin D has also been studied to see if it has anticancer effects. Skin exposed to sunshine can make vitamin D. Vitamin D can also be consumed in the diet and in dietary supplements. Taking vitamin D in doses from 400-1100 IU/ day has not been shown to lower or increase the risk of cancer.

The VITamin D and OmegA-3 TriaL (VITAL) is under way to study whether taking vitamin D (2000 IU/ day) and omega-3 fatty acids from marine (oily fish) sources lowers the risk of cancer.

The Physicians’ Health Study found that men who have had cancer in the past and take a multivitamin daily may have a slightly lower risk of having a second cancer.

See the following PDQ summaries for more information:

New ways to prevent cancer are being studied in clinical trials.

Information about clinical trials supported by NCI can be found on NCI’s clinical trials search webpage. Clinical trials supported by other organizations can be found on the ClinicalTrials.gov website.

About This PDQ Summary

About PDQ

Physician Data Query (PDQ) is the National Cancer Institute’s (NCI’s) comprehensive cancer information database. The PDQ database contains summaries of the latest published information on cancer prevention, detection, genetics, treatment, supportive care, and complementary and alternative medicine. Most summaries come in two versions. The health professional versions have detailed information written in technical language. The patient versions are written in easy-to-understand, nontechnical language. Both versions have cancer information that is accurate and up to date and most versions are also available in Spanish.

PDQ is a service of the NCI. The NCI is part of the National Institutes of Health (NIH). NIH is the federal government’s center of biomedical research. The PDQ summaries are based on an independent review of the medical literature. They are not policy statements of the NCI or the NIH.

Purpose of This Summary

This PDQ cancer information summary has current information about cancer prevention. It is meant to inform and help patients, families, and caregivers. It does not give formal guidelines or recommendations for making decisions about health care.

Reviewers and Updates

Editorial Boards write the PDQ cancer information summaries and keep them up to date. These Boards are made up of experts in cancer treatment and other specialties related to cancer. The summaries are reviewed regularly and changes are made when there is new information. The date on each summary (“Updated”) is the date of the most recent change.

The information in this patient summary was taken from the health professional version, which is reviewed regularly and updated as needed, by the PDQ Screening and Prevention Editorial Board.

Clinical Trial Information

A clinical trial is a study to answer a scientific question, such as whether one treatment is better than another. Trials are based on past studies and what has been learned in the laboratory. Each trial answers certain scientific questions in order to find new and better ways to help cancer patients. During treatment clinical trials, information is collected about the effects of a new treatment and how well it works. If a clinical trial shows that a new treatment is better than one currently being used, the new treatment may become “standard.” Patients may want to think about taking part in a clinical trial. Some clinical trials are open only to patients who have not started treatment.

Clinical trials can be found online at NCI’s website. For more information, call the Cancer Information Service (CIS), NCI’s contact center, at 1-800-4-CANCER (1-800-422-6237).

PDQ® Screening and Prevention Editorial Board. PDQ Cancer Prevention Overview. Bethesda, MD: National Cancer Institute. Updated <02/20/2020>. Available at: https://www.cancer.gov/about-cancer/causes-prevention/patient-prevention-overview-pdq. Accessed <01/19/2021>. [PMID: 26389424]

 

Understanding Cancer Research Study Design and How to Evaluate Results

Photo of scientist doing cancer research SCOR

Approved by the Cancer.Net Editorial Board, 04/2018

Doctors and scientists conduct research studies to find better ways to prevent and treat cancer. Depending on the questions they want to answer, researchers can design these studies in different ways. No study design is perfect. Each has strengths and drawbacks. It is important to understand a study’s design. By doing this, you can understand the results to know if they apply to your situation.

In cancer research, there are 2 main types of research studies:

  • Experimental studies. This type of study provides an intervention, such as a new treatment. The intervention is given to a group of people. Then, researchers compare their results to those of another group that does not receive the intervention. This other group is known as the control group. The researchers choose who does and does not receive the intervention either randomly or through a selection process. Experimental studies help researchers learn more about how cancer starts or spreads. These studies can also test new imaging techniques and explore quality of life issues.
  • Observational studies. This type of study involves observing groups of people in a natural setting and looking at a specific result. A result may include whether 1 group of people has more cancer diagnoses than another group. In these studies, the researchers cannot control the intervention, such as a person’s weight or whether they took vitamin supplements. These studies are often described as epidemiologic. Epidemiology involves studying how different risks cause or spread a disease in a community.

Types of experimental studies

Experimental studies are more reliable than observational studies. This is because the volunteers are placed in the intervention or control group by chance. This reduces the likelihood that the assumptions or preferences of the researchers or volunteers will change the study results. Such assumptions or preferences are called bias.

This type of study also helps researchers to better find and control other factors, such as age, sex, and weight. These factors can affect the results of the study.

Researchers may also consider certain factors when choosing people to enroll in an experimental study. They could be based on type of cancer, stage of the disease, or whether the cancer has spread.

One of the most common types of experimental studies is the clinical trial. This is a research study that tests a medical intervention in people. Clinical trials test:

  • The effectiveness or safety of a new drug or combination of drugs
  • A new approach to radiation therapy or surgery
  • A new treatment or way to prevent cancer
  • Ways to lower the risk of cancer coming back

Doctors and researchers conduct clinical research in segments called phases. Each phase of a clinical trial provides different answers about the new treatment. For instance, it can show the dose, safety, and efficacy of the treatment. The efficacy is how well the treatment works. There are 4 phases of clinical trials.

In a clinical trial, volunteers are usually selected by chance to either be in the treatment or control group. Researchers can prevent bias in a clinical trial by keeping volunteers and/or themselves from knowing how the volunteers are grouped. This is a process known as “blinding.”

Types of experimental studies include:

  • Double-blind randomized trial. Most scientists believe this type of clinical trial will produce the best evidence in a study. Neither the volunteers nor the researchers know who belongs to a treatment or control group until the study ends.
  • Single-blind randomized trial. In this type of trial, the volunteers do not know whether they belong to a treatment or control group. But the researchers know.
  • Open/unblinded trial. Both volunteers and researchers know who belongs to each test group in this type of study. This occurs when it is not possible to use blinding. For instance, the study could compare a surgical treatment to a drug.

Types of observational studies

In observational studies, researchers have less control over the study volunteers. This means that certain factors could affect the results. These studies, however, are useful in providing initial evidence that can help guide future research.

Types of observational studies include:

  • Case-control studies. These types of studies compare 2 groups of people. For instance, they could compare those who have cancer (the case) and those who do not (the control). Researchers may look for lifestyle or genetic differences between the 2 groups. By doing this, they hope to find out why 1 group has a disease and the other group does not. These studies are conducted retrospectively. That is, they are researching what has already happened.
  • Cohort studies. These studies are prospective, which means that researchers study the event as it occurs. They monitor a group of people for a long time and track something. For example, they could track any new cancer diagnoses. This type of study can assess whether certain nutrients or actions can prevent cancer. This approach can also find cancer risk factors. For instance, cohort studies have looked at whether postmenopausal hormone replacement therapy increases the risk of breast cancer.
  • Case reports and case series. These studies are detailed descriptions of a patient’s medical history. The individual patient descriptions are called case reports. If many patients receive a similar treatment, the case reports may be combined into a case series. The results of case series studies are descriptions of patients’ histories within a specific group. As such, they should not be used to determine treatment options.
  • Cross-sectional studies. These studies examine how diseases interact with other factors within a specific group at a point in time. But because these studies only measure interactions at a single point in time, they cannot prove that something causes cancer.

Types of review articles

A large number of cancer research studies are published every year. Given this, it is challenging for doctors, as well as interested patients and caregivers, to keep up with the latest advances. Research studies published in journals are constantly shaping and reshaping the scientific understanding of that subject. No single study provides the final word on a topic, type of cancer, or treatment. As a result, review articles, which evaluate and summarize the findings of all published research on a certain topic, are extremely helpful.

Types of review articles include:

  • Systematic reviews. These articles summarize the best available research on a specific topic. Researchers use an organized method to locate, gather, and evaluate a number of research studies on a particular topic. By combining the findings of a number of studies, researchers are able to draw more reliable conclusions.
  • Meta-analyses. These studies combine data from several research studies on the same topic. By combining these data, a meta-analysis can find trends that are hard to see in smaller studies. But if the single studies were poorly designed, the results of the meta-analysis may not be useful.

Evaluating research studies

Here are some tips for finding out the quality of a research study:

  • Find out if the journal uses a peer-review process. Results from a study are more reliable if they are peer-reviewed. This means that researchers who are not a part of the study have looked over and approved the design and methods.
  • Look at the length of the study and the number of people involved. A study is more useful and credible if the same results occur in many people across a long time. Studies of rare types of cancer or cancers with a poor chance of getting better are an exception to this rule. This is because there are a small number of patients to study. Also, when looking at the length of the study, it may be suitable for some clinical trials to be shorter. For instance, cancer prevention trials are often much longer than treatment clinical trials. This is because it usually takes longer to figure out if a prevention strategy is working compared to a treatment.
  • Consider the phase of the study when learning about new treatments. Phase I and II clinical trials usually tell you more about the safety of a treatment and less about how well it works. These studies tend to have a smaller number of patients compared to phase III clinical trials.  Phase III clinical trials compare a new treatment with the standard of care. “Standard of care” means the best treatments known. Doctors consider phase III clinical trials to be the most reliable.
  • Find out if the study supports or contradicts current research. New results are exciting, but other researchers must validate the results before the medical field accepts them as fact. Review articles like systematic reviews are of special interest. They review and draw conclusions across all of the published research on a specific topic.
  • Watch out for conclusions that overstate or oversimplify the results. Each study is a small piece of the research puzzle. Medical practice rarely changes because of the results of a single study.

Questions to ask your health care team

Always talk to your health care team about what you find in an abstract or study. If you have reviewed a study that suggests a different approach to cancer treatment, do not stop or change your treatment. First talk with your health care team about how the study relates to your treatment plan.

Consider asking your health care team the following questions:

  • I recently heard about a study that used a new treatment. Is this treatment related to my type and stage of cancer?
  • What type of journals should I read to learn more about my type of cancer?
  • Should I consider being a part of a clinical trial?
  • What clinical trials are open to me?
  • Where can I learn more about clinical trials?

Cancer Disparities

Cancer disparities across ethnicity, gender, age. SCOR

Although cancer incidence and mortality overall are declining in the United States, certain groups continue to be at increased risk of developing or dying from particular cancers. Credit: iStock

Cancer affects all population groups in the United States, but due to social, environmental, and economic disadvantages, certain groups bear a disproportionate burden of cancer compared with other groups.

Cancer disparities (sometimes called cancer health disparities) are differences in cancer measures such as:

  • incidence (new cases)
  • prevalence (all existing cases)
  • mortality (deaths)
  • survival (how long people survive after diagnosis)
  • morbidity (cancer-related health complications)
  • survivorship (including quality of life after cancer treatment)
  • financial burden of cancer or related health conditions
  • screening rates
  • stage at diagnosis

Cancer disparities can also be seen when outcomes are improving overall but the improvements are not seen in some groups relative to other groups.

Population groups that may experience these disparities include groups defined by race/ethnicity, disability, gender identity, geographic location, income, education, age, sexual orientation, national origin, and/or other characteristics. Read more HERE.

 

Cancer Disparities was originally published by the National Cancer Institute.

Developing Clinical Trials to Advance Care for Brain and Spine Cancers

Clinical trials are vital to improving care and treatment for central nervous system (CNS) cancers. These rare cancers represent 1.3% of all new cancer cases in the United States. The overall five-year relative survival rate is 32.6%, and even lower for patients with the most malignant tumors. Clinical trial development can help advance treatments and improve outcomes for people and families impacted by brain and spine tumors.

Clinical trial development is the process that determines which therapies should be tested in humans and how. The NCI’s Neuro-Oncology Branch (NOB) is taking a comprehensive approach to designing clinical trials that includes a robust clinical research and translational laboratory program. This often starts with basic research in areas that show promise for developing new treatments. Promising therapies are then tested in diverse laboratory model systems, and finally translated into clinical studies.

Yet, developing successful clinical trials for brain and spine cancers has unique challenges. Mark Gilbert, M.D., and Terri Armstrong, Ph.D., chief and deputy chief of the Neuro-Oncology Branch, hope to overcome these challenges through education and innovative approaches and designs. These include measuring the impact of a treatment on the person and eliminating barriers to participation.

Unique Challenges

Unique challenges can include those related to the relative rarity of these tumors and also characteristics of these tumors. The low incidence and prevalence of CNS tumors also result in geographical barriers that make it extremely challenging to find people to enroll in clinical trials. Study design and participation can be even more challenging for studies that look at specific molecular tumor subtypes.

Enthusiasm and interest for brain and spine cancers are often not a high priority for drug developers or pharmaceutical companies due to the low incidence and prevalence, and funding opportunities are limited for rare cancers. However, the U.S. Food and Drug Administration (FDA) Rare Disease Program encourages research in the area of rare diseases.

Clinical trials that require frequent visits, in person treatments, and long travel may prevent a person from being able or willing to participate. Such logistics can also place additional strain on caregivers and families.

“A unique challenge that researchers face when developing neuro-oncology trials is drug delivery that crosses the blood-brain barrier,” Dr. Gilbert says. The blood-brain barrier is a protective layer that allows certain substances to reach the brain but prevents others that it thinks are harmful, such as cancer-treating drugs. Researchers must either select drugs that are able to cross or find innovative ways to get a treatment to reach the brain. Once there is a portfolio of drugs that are able to cross the blood-brain barrier and reach the tumor, the next challenge is to determine which drug or drug combinations are best for each patient. This requires extensive research looking for targets in the tumors that are likely to respond to available therapies. This process is often referred to as Precision Medicine.

Approach to Development

Clinical trial development starts with the researcher asking an important question. This helps to formulate the hypothesis and is the reason for developing a trial.

“Clinical trials need to be driven by a hypothesis that is testable,” Dr. Gilbert says. “Everything builds on the hypothesis, including the patient population, eligibility criteria, and statistical analysis.”

It is also important to evaluate background information by asking such questions as:

  • Is the clinical trial a good option for patients? Is it going to provide robust or meaningful information?
  • What is the likelihood of answering the research question or hypothesis?
  • Is the study designed with appropriate statistics?
  • Is the eligibility criteria suitable or is it providing unnecessary risk to patients?

When considering a clinical trial, researchers should also review trials that are currently available and determine what is missing for people with brain and spine tumors. “A researcher should also investigate what is available outside of neuro-oncology to see if there is a drug in development that could potentially be beneficial,” says Dr. Armstrong.

The Neuro-Oncology Branch researchers primarily focus on novel ideas for early phase clinical trials, such as phase I, phase II, or first-in-human trials.

Clinical Trials for Brain and Spine Tumors


Importance of Patient Outcome Measures

Brain and spine tumors are unique because they are both a cancer and a neurologic illness. Dr. Armstrong’s research shows that people with brain and spine tumors are symptomatic and have functional limitations often from the time of diagnosis. Patient outcome measures are important because researchers are able to capture the impact of the disease. These reports help researchers learn how a person functions at the time of diagnosis and additionaly, provides insight into their well-being and treatment impact. “Treatments that extend time to progression or extend survival affect how the person feels and functions and is critical to truly understanding the impact of a therapy,” says Dr. Armstrong.

Besides living longer, patients reported that they want to be able to walk, do usual activities, and reduce their symptoms. These results are the driving force behind Dr. Armstrong’s work and have led to the integration of patient-reported outcomes in clinical trial development.

Patient-reported outcomes allow researchers to systematically capture data on the symptoms and experiences of patients in clinical trials and should be included when developing trials. Patient outcome measures can provide powerful insight into the patient experience even if a treatment does not shrink a tumor.

The FDA also encourages including clinical outcome assessments in clinical trial development. A new treatment can be approved by the FDA if the treatment improves survival or if it improves how a person feels or functions.

Measuring Success

A successful clinical trial advances the field by acquiring new knowledge. A clinical trial can be defined as successful if it improves survival. However, a study can also be deemed successful if it advances the understanding of the disease or leads to improvements in the approach and design of trials.

For example, a randomized trial of dose-dense temozolomide in newly diagnosed glioblastoma found no difference in overall or progression-free survival between treatment groups. However, it was one of the first studies to require a tumor tissue sample as part of eligibility, and 97% of participants complied showing the feasibility of obtaining tissue to confirm prognosis and further research.

Additionally, a trial of dose-dense temozolomide and lapatinib in recurrent ependymoma included patient-reported outcome measures and found that patients with stable disease reported significant improvements in their symptoms and function. This study led to this treatment being approved as a standard treatment because it improves how patients feel and function and highlights the importance of capturing a comprehensive picture of the patient experience.

Advancing Education and the Future

Researchers and neuro-oncology providers can join the Society for Neuro-Oncology’s two-day virtual clinical trials course on November 17 to 18, 2020 to learn the principles and future direction of CNS trials and to better understand barriers to patient participation.

Drs. Gilbert and Armstrong will be providing their perspective and expertise during the course. Dr. Gilbert will share how to successfully navigate the clinical trial environment, while Dr. Armstrong teaches about the importance of including patient outcome assessments.

“It is important that investigators learn the scientific method to research, including hypothesis-driven trials that use appropriate tools to measure patient outcomes,” Dr. Armstrong says.

The Neuro-Oncology Branch leads a network of investigators across the nation called the Brain Tumor Trials Collaborative as a means to advance treatments for primary brain and spine tumors through smart and novel clinical trial development.

When thinking about future directions of clinical trials in neuro-oncology, both Drs. Gilbert and Armstrong emphasize the importance of pragmatic clinical trial design. This can include designing trials using oral treatments that patients can take at home, partnering with a local provider to administer treatments, broadening eligibility criteria, or requiring infrequent visits.

Source: NCI Center for Cancer Research

FirstHealth OK’s Cancer Center Project

From www.thepilot.com
October 23, 2020
by Laura Douglass

FirstHealth new cancer center FirstHealth of the Carolinas has approved a key step toward beginning its $68 million cancer center, finalizing interior architectural plans.

The facility, to be built across the street from its campus on Page Road, features a four-story building and adjoining parking deck across the street from Moore Regional’s main hospital campus in Pinehurst.

“The development of the FirstHealth Comprehensive Cancer Center on the Moore Regional campus is a major step forward for patients and families in our community and surrounding areas who are facing a cancer diagnosis,” said Sherwood Blackwood, chairman of FirstHealth’s Board of Directors.

While FirstHealth has a long-standing history of providing exceptional cancer services, the current facilities have been forced to grow and expand to meet the cancer care needs of the community in a less-than-ideal fashion.

“The cancer center will bring together all outpatient cancer treatments and support services into one state-of-the-art facility offering our community the highest quality and patient-centered cancer care right here at home. On behalf of the FirstHealth Board of Directors, we’re thrilled to support this worthwhile project to allow FirstHealth to advance cancer services in our region and continue to fulfill its core purpose to care for people,” he added. “I’d like to thank the many people; staff, volunteers and donors who have helped make this dream a reality. This facility is a game changer for the thousands of people who are affected by cancer.”

FirstHealth of the Carolinas serves 15-counties in central North Carolina. While the region’s population has grown, so too has the cancer rate.

“We feel this is a good time to build a comprehensive cancer center,” said Firsthealth CEO Mickey Foster. “This brings everything together under one roof. It also gives us the space to give multidisciplinary care for our patients.”

Land clearing is already underway for the parking deck and work should be completed in May. Construction of the center itself will begin about that same time frame and should wrap up in late 2022.

Dr. Daniel Barnes, president of FirstHealth Physicians Group presented the final design to hospital trustees on Tuesday.

“This is one of the most significant things FirstHealth has done since the Reid Heart Center and FirstHealth Moore Regional-Hoke campus were built,” Barnes said. “We are starting to see the project evolve and everyone along the way is excited and looking forward to the future and what we can offer.”

To help refine the Cancer Center’s initial design, CPL: Architecture erected to-scale versions of various clinical spaces inside an Aberdeen warehouse. This “cardboard city,” as it was nicknamed, let medical providers, staff and FirstHealth trustees walk-through different parts of the proposed building to better assess the functionality of each space before construction begins.

“It allowed us to come up with innovative ideas,” Barnes said. “We had a significant amount of input through the cardboard city. It helped move along the design process even further. The design really is a compilation of the input of all the various stakeholders in the process.”

The life-sized mock-up should also provide substantial cost-savings over time, he added, as fewer change orders are anticipated. The cardboard rooms were detailed all the way down to where electrical outlets would be installed.

“It is a different approach to design. We’d rather make any small changes now rather than later,” said FirstHealth’s project manager, Cindy Hetzler.

Robin Washco of CPL: Architecture said the to-scale model allowed different departments to better understand how the building would flow from one section to another.

“It is easier to envision the space this way,” she said. “Another goal was also to standardize the spaces, such as exam rooms. That works better from an operational standpoint and a budget standpoint as well.”

Foster said developing plans through the use of a cardboard city model is new for FirstHealth, but considered best practice for a modern, large construction project.

“This has to be one of the most well-thought out plans I’ve seen in my cancer center career,” Foster said.

Laura Kuzma, FirstHealth’s director for oncology support services and patient navigation, also worked closely with the architectural team and surveyed 80 FirstHealth cancer patients to help ensure the final design is also patient-friendly.

The Cancer Center’s healing garden will serve as the building’s focal centerpiece. The infusion chemotherapy area, where many patients spend long periods undergoing treatment, received particular attention. The large open-space includes private, semi-private and communal areas — most within view of an expansive glass window overlooking the healing garden.

“We wanted to create a place that met everyone’s needs, no matter where they are in their (cancer) journey,” Kuzma said.

Foster said the uniqueness of the fourth floor — set aside for patient support services — also differentiates the facility.

“There is an exercise gym for patients, a meditation space, massage spaces, community classrooms where support groups will meet, a patient resource room, palliative care, and this where the nurse navigators will be. They have one of the most important roles in cancer care.”

As a matter of convenience, the four-story adjacent parking garage will provide 500 parking spots with a drop-off area for patients. On the first floor, the new center will have a bistro cafe with healthy drinks, smoothies and other food options for patients and visitors.

Importantly, the new comprehensive cancer center will house FirstHealth’s clinical trials and research program. Initiated first in the early 1990s, the program has expanded with most trials focused primarily on breast cancer, lung cancer, colon cancer and prostate cancer.

Last year, FirstHealth made history twice: enrolling the first patient into a worldwide trial testing the efficacy and safety of immune therapies designed to battle cervical cancer, and as the first health care system in the nation to participate in a clinical study with Intuitive Surgical’s ion endoluminal system, a catheter-based, robotic-assisted technology.

In recent weeks, Moore Regional Hospital made history again as the first site to enroll a patient into a clinical trial for a new regimen to treat COVID-19 patients. Results from the study could be available by the end of the year, according to Dr. Gretchen Arnoczy, an infectious diseases physician with FirstHealth.

Earlier this year, Moore Regional Hospital was named in the top five of the state’s best hospitals, climbing from an 11th place ranking just one year ago. Perhaps more importantly, the flagship facility of FirstHealth of the Carolinas, along with Moore Regional Hospital-Hoke and Richmond campuses, was also recently ranked No. 4 for “patient picks” according to Business North Carolina magazine.

For more information about cancer clinical trials in your area, click HERE