Balance Hope and Quality of Life for Phase I Clinical Trials
Leita, a 42-year-old patient with locally advanced pancreatic cancer, was treated with 5-fluorouracil, irinotecan, and oxaliplatin followed by capecitabine and radiation therapy. After she completed initial treatment, a computed tomography scan conducted in preparation for a possible surgical resection revealed metastatic liver lesions. Leita’s surgery was cancelled, and she began second-line therapy with gemcitabine and nab-paclitaxel.
Drug Clinical Trials Focus on Efficacy Over Quality of Life
The clinical trials that lead to new drug approvals or expanded indications are quick to praise a therapy’s clinical benefits, such as longer survival or time to progression, but only about one in five of those trials find improvements in patients’ quality of life, researchers reported in JAMA Oncology.
Healthcare Organizations Advocate for Clinical Trial Diversity in Letter to Congress
Healthcare organizations advocated to improve diversity among clinical trials in a letter sent to U.S. Congress in May encouraging the government to take steps as the reauthorization of the Prescription Drug User Fee Act (PDUFA) approaches. The PDUFA allows the U.S. Food and Drug Administration to review and approve drugs, but the authorization is set to expire in September of 2022.
NCI Hosts Virtual Roundtable Discussion on Expanding Clinical Trial Accrual
Driven by the reignited Cancer Moonshot, the National Cancer Institute (NCI) hosted a virtual roundtable discussion on the possibilities and challenges of increasing clinical trial accrual in May 2022.
FDA’s Industry Guidance Will Increase Racial and Ethnic Diversity in Clinical Trials
New draft guidance from the U.S. Food and Drug Administration (FDA) facilitates enrolling more participants from underrepresented racial and ethnic U.S. populations into industry clinical trials. According to FDA, despite their disproportionate burden for certain diseases, racial and ethnic minorities are frequently underrepresented in research and expanding diversity in clinical trials is an important step to reduce those disparities.
Advocate for Equal Access for Next Generation Sequencing and Clinical Trials
Janice is an oncology nurse in a rural community cancer center. Only one of the three oncologists in the practice discusses clinical trials with their patients and typically not until after patients complete two to three lines of therapy. Also, the practice does not have a process for when to order next generation sequencing (NGS). Janice feels it is not ethical that the patients coming to the clinic do not have equal access to those important services.
The Case of the Clinical Trials Consultation
Don, age 72, was diagnosed with borderline resectable pancreatic adenocarcinoma more than a year ago. Genetic testing indicated a BRCA2 variant. He completed 12 cycles of FOLFIRINOX followed by a pancreaticoduodenectomy (Whipple procedure). He had no evidence of disease for six months until a liver lesion seen on surveillance imaging tested positive for metastatic pancreatic cancer. His medical oncologist suggests a clinical trial targeting the BRCA2 variant.
Help Patients Understand Biomarker Test Results and Clinical Trials Options
Many of today’s new drug approvals and standard-of-care treatments have a companion diagnostic test that identifies biomarkers in a patient’s tumor tissue or blood to determine whether they are an appropriate candidate for the therapy. When those results show that they’re not a good match for the U.S. Food and Drug Administration (FDA)-approved treatment, the findings may identify a biomarker-directed clinical trial as an alternative option. Here’s how oncology nurses can help patients understand which clinical trials listed on their test results might be an option for them.
Traits That Make You a Great Nurse Also Lead to Success as a Clinical Trials PI
Clinical trials are led by a principal investigator (PI) with a research team that may include physicians, nurses, social workers, and other healthcare professionals. PIs can represent a variety of disciplines, and nurse scientists often hold that role.
Use ClinicalTrials.gov to Find the Right Cancer Research Studies for Your Patients
Among the many online resources for identifying cancer clinical trials, including the National Cancer Institute (NCI), NCI-designated cancer centers or academic cancer centers, and drug and biotechnology companies, ClinicalTrials.gov may be the most comprehensive as a one-stop shop for patients and providers to find publicly and privately supported trials for patients.
Patients Cope With Intense Emotions After Clinical Trial Withdrawal
When withdrawing from a clinical trial, patients experience a spectrum of emotions ranging from regret, urgency, frustration—and trust in their healthcare professionals, like oncology nurses, according to the results of a study published in JAMA Network Open.
Not Eligible for Trials? Expanded Access May Give Patients Options for Investigational Products
The U.S. Food and Drug Administration’s (FDA’s) expanded access program is a pathway for providers to request using an investigational medical product to treat a patient with an immediately life-threatening or serious disease or condition outside of clinical trials when no comparable or satisfactory alternative therapy options are available. FDA’s Project Facilitate, a comprehensive program within FDA’s Oncology Center of Excellence, makes the pathway more accessible by assisting oncology healthcare professionals in submitting single-patient oncology expanded access applications.
Nursing Roles in Clinical Trials
Clinical trials provide evidence to support what you do in your work as a nurse every day. They are tools to discover new therapies and identify side effects while considering patient-specific factors like age, comorbidities, race, and sex. They build support for best practices in treatment and patient care.
Immunotherapy Extends Survival in Uveal Melanoma
Patients with uveal melanoma who were treated with tebentafusp, an investigational immunotherapy, lived a median 5.7 months longer than those in comparison groups, researchers reported in study findings presented at the American Association for Cancer Research 2021 annual meeting.
How to Overcome Underrepresentation in Oncology Clinical Trials and Research Studies
For the findings to be usable, healthcare research clinical trials must accrue participants that accurately represent the general population to which the study applies. But that’s easier said than done. During a session on April 27, 2021, for the 46th Annual ONS Congress™, two oncology nurse scientists shared strategies that other researchers can use to overcome disparities in clinical trial study populations.
FDA Approves Fam-Trastuzumab Deruxtecan-Dxki for HER2-Positive Gastric Adenocarcinomas
On January 15, 2021, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu®) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
FDA Approves Osimertinib as Adjuvant Therapy for NSCLC With EGFR Mutations
On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved osimertinib (Tagrisso®) as adjuvant therapy after tumor resection for patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations, as detected by an FDA-approved test.
Telegenetic Counseling Bridges Geographic Barriers and Minimizes Distress
Our 2009–2014 study, Bridging Geographic Barriers: Remote Cancer Genetics Counseling for Rural Women, also known as the REACH Project (Risk Education and Assessment for Cancer Heredity), was the first randomized, noninferiority trial of telephone-based BRCA1 and BRCA2 counseling and testing that used a population-based traceback approach to identify and counsel both rural and urban women who were at increased risk for hereditary breast and ovarian cancer but had not received genetic counseling or testing.
Study Links HPV Vaccine to Reduced Rates of Cervical Cancer
Cervical cancer rates have dropped more than 90% among women who received the human papillomavirus (HPV) vaccine, according to the results of a Swedish study published in the New England Journal of Medicine. Global health leaders are calling it a milestone study.
Radiation Clinical Trials Must Evolve to Include Patient-Reported Outcomes
Prostate cancer is one of the most common cancers treated with radiotherapy (RT). Conventional RT for low-risk patients usually involves 40–45 treatments given over eight or nine weeks. Several studies suggest that hypofractionated RT—fewer treatments but with a higher dose per treatment—may produce a similar survival benefit. When two treatments have similar survival outcomes, the decision process looks at symptom profiles, quality of life, and cost.
The Case of the HPV-Positive Perk
Warren is a 50-year-old man recently diagnosed with human papillomavirus (HPV)-positive oropharyngeal cancer. He and his wife meet with a radiation oncologist and develop a plan of care. Lisa, the radiation oncology nurse, meets with the couple to provide education and answer questions. Darren tells her that two of his “hard living” uncles died from head and neck cancer and the treatment was horrible. He says, “I’ve only had two sexual partners and never smoked—is this cancer really worth treating?”
Prostate Cancer Clinical Trials Don’t Reflect Racial Diversity—And It’s Getting Worse Over Time
More than 96% of participants in prostate cancer clinical trials are non-Hispanic white men even though non-Hispanic black men represent 22% of prostate cancer diagnoses, researchers reported in Cancer Epidemiology, Biomarkers, and Prevention. Even more critical, enrollment rates of black or African American men have been declining since 1995.
Geographic Disparities Affect Clinical Trials Participation for Minorities
Clinical trials are a vital part of moving cancer care into the future. Enrollment and participation provide patients with cutting-edge treatments and build the knowledge base for clinicians to offer the best possible care available. Patients who enroll in clinical trials receive a high quality of care, increased surveillance, and a greater adherence to treatment protocols because of the nature of scientific study. However, Latino and African American participation in clinical trials is low compared to their representation in the U.S. population.
FDA Issues Guidance for Conducting Clinical Trials During COVID-19
On March 18, 2020, the U.S. Food and Drug Administration (FDA) issued a guidance for industry, investigators, and institutional review boards conducting clinical trials during the COVID-19 coronavirus pandemic in recognition that it may affect the conduct of clinical trials of medical products, including drugs, devices, and biologic products.
Clinical Trial Participants Average 6.5 Years Younger Than Actual Cancer Populations
For the four most common cancer sites (breast, prostate, colorectal, and lung cancer), the median age of patients in clinical trials is an average of 6.5 years younger than the median age of patients diagnosed with that cancer. And the age disparity is worsening, researchers reported in JAMA Oncology.
New CAR T-Cell Targets Show Safe Results in Early Clinical Trials
Findings from two phase I clinical trials presented at the American Association for Cancer Research 2019 annual meeting indicate that targeting CAR T cells against mesothelin for advanced solid tumors and HER2 for advanced sarcoma is safe and shows clinical antitumor activity.
Nurses Must Be Pharmacovigilant With Emerging Cancer Treatments
The field of cancer care is changing and evolving like never before. In 2018, the U.S. Food and Drug Administration (FDA) approved a number of new biosimilars, targeted agents, and agents that target certain mutations regardless of tumor site. New requirements for accreditation and reimbursement mean oncology nurses are being used in a growing number of new or developing roles including navigation and survivorship. On Thursday, April 11, 2019, Kathleen Wiley, RN, MSN, AOCNS®, addressed these emerging trends and more in a clinical chat at the ONS 44th Annual Congress in Anaheim, CA.
Drug Pricing Talks; Clinical Trial Barriers; Survivorship Challenges
Rising prescription medication costs has been a major focus area for both the Trump administration and the 116th Congress. In January 2019, both the House and Senate committees of jurisdiction held public hearings on soaring drug costs. Despite constant media attention and mounting pressure from government officials, no pharmaceutical company executives chose to testify. Congress threatened to subpoena the industry if it happened again.
VA and NCI Collaborate on Access to Cancer Clinical Trials
A new cross-government program is underway to improve veterans’ access to clinical cancer trials. Together with the National Cancer Institute (NCI), the Department of Veterans Affairs (VA) Interagency Group to Accelerate Trials Enrollment launched in 12 VA facilities in summer 2018.
How Is CTCAE Improving Research and Patient Care?
The Common Terminology Criteria for Adverse Events (CTCAE) is a list of adverse event (AE) terms most often encountered in oncology. It’s been in ongoing development since the 1980s and was previously referred to as the Common Toxicity Criteria. Through continual development and support from the National Cancer Institute’s Cancer Therapy Evaluation Program, CTCAE aids in the documentation and analysis of adverse events in oncology-related clinical trials.
What Would You Say if Your Patient on a Clinical Trial Needs to Visit the Dentist?
One of your patients is enrolled in a clinical trial and is scheduled to receive an investigational drug today. She reports a cracked tooth and asks if it’s okay to get dental work. What should you tell her?
A. To Set up an appointment with her dentist between treatment cycles.
B. To check with her research team before setting up a dental appointment.
C. Not to have any dental work done since she’s on a clinical trial.
D. Have her tooth fixed right away and let the research team know if you have any problems.
Consider a Role in Clinical Trials Research as an Evolution of Your Nursing Career
Nurses can do it all. After all, the often-unsung heroes of health care use their unique skills to positively impact patients and their families in more ways than most people can ever imagine. Unfortunately, role confusion and a lack of awareness of a vital specialty have led to a dire need of nurses in clinical trials.
Communication, Organization Are Top Drivers of Oral Adherence in Clinical Trials
Oncology nurses know the challenges of patient adherence to oral cancer therapies. Every dose a patient misses can affect their outcomes and chance of survival. But in clinical trials, oral adherence has even broader implications: when a study is evaluating the efficacy of a drug, it depends on study participants taking it exactly as the trial outlines.
What You Need to Know About Obtaining Informed Consent
Informed consent is a comprehensive process as opposed to a check mark on a list of tasks to complete prior to starting cancer therapy. The American Society of Clinical Oncology/ONS Chemotherapy Administration Safety Standards explain that informed consent provides a patient with “sufficient information about the disease diagnosis and treatment options so that the individual can make a reasonable decision about treatment on the basis of an understanding of the potential risks and anticipated benefits of the treatment.”
Geographic Health Disparities Affect Access to Clinical Trials
Geographic location impacts life expectancy and even cancer care. Marylynn Ostrowski Ireland, PhD, of Viability, Inc., and Deborah Watkins Bruner, PhD, RN, FAAN, of Emory University in Atlanta, GA, discussed geographic health disparities during a session at the 43rd Annual Congress in Washington, DC.
The Case of the Pain Paradox: Follow-Up and Clinical Trial
The January 2018 case study introduced Vince, a 55-year-old man receiving chemotherapy and radiation for recurrent bladder cancer. He suffers from chronic back pain because of spinal stenosis and has been on opioid therapy for nearly two years.
How the FDA Provides New Approaches to Old Problems
Every quadrennial presidential cycle, as the newly elected leader moves into the Oval Office, he selects a core group of advisors who are philosophically aligned and eager to make changes in the federal government’s process. However, this is often not as simple as the new administration believes.
How Do You Find Clinical Trials Through the NCI’s Advanced Clinical Trials Search?
As part of the National Cancer Moonshot Initiative and in collaboration with the Presidential Innovation Fellows, the National Cancer Institute (NCI) developed and launched a new website in 2016. It provides user-friendly access to the repository of abstracts of cancer clinical trials that NCI supported.
Oncology Nurses Drive Change In Cancer Care With Clinical Trials
Clinical trials are responsible for discovering new treatments for cancer as well as the continued evolution of standards of care in clinical practice. Nationally, less than 5% of all eligible adult patients with cancer enroll in clinical trials. Additionally, it takes a drug an average of six to eight years from when it is first introduced in trials to become fully available to all patients who could benefit from it.
FDA Halts Two Clinical Trials Evaluating Pembrolizumab in Patients With Multiple Myeloma
On August 31, 2017, based on data from two recently halted clinical trials, the U.S. Food and Drug Administration (FDA) is issuing a statement to inform the public, healthcare professionals, and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Keytruda (pembrolizumab) is not approved for treatment of multiple myeloma.
How Are Patients Randomized to Cancer Clinical Trials?
Before any new treatment or approach is used with people in clinical trials, researchers work to understand its effects on cancer cells in the lab and in animals. Researchers design cancer clinical trials to test new ways to treat, detect, diagnose, and prevent cancer, and manage symptoms of cancer and side effects from treatment.
How One Institution Improved Accrual to Cancer Clinical Trials
One of the key factors to a cancer clinical trial’s success is the ability to enroll an adequate number of patients in an appropriate timeframe. Identifying barriers to slow accrual and ways to address them can help researchers and nurse scientists make big steps in the fight against cancer in the era of the National Cancer Moonshot Initiative.
How Oncology Nurses Can Contribute to Immunotherapy Clinical Trials
Using the human immune system to target cancer has made tremendous strides in recent years. Jaruska Naidoo, MBBCh, from the Sidney Kimmel Comprehensive Cancer Center, and Joanne Riemer, RN, BSN, from Johns Hopkins University, discussed the progress made in immunotherapy and how nurses play a role in clinical trials during a session at the 42nd Annual Congress in Denver, CO.