Advocate ‘Walks the Talk’ Regarding Cancer Clinical Trials

From oncnursingnews.com
By Brielle Benyon, March 12, 2019

Clinical trials are about more than just collecting data – they’re about survivorship and family. This was the focus of Rose Gerber’s talk at the CURE Patient-Focused meeting at the 36th Annual Miami Breast Cancer Conference.

“There are different stakeholders in clinical trials,” said Gerber, a breast cancer survivor herself and the director of Patient Advocacy and Education at the Community Oncology Alliance (COA). COA’s mission is to advocate for the preservation of cancer care – especially when it comes to community cancer practices.

“When we think about clinical trials, to me in my mind, it’s about survivorship and family.”

Gerber was involved in a clinical trial, testing the efficacy of trastuzumab (Herceptin). She said that her oncologist referred her to the trial, but everyone on the treatment team plays a role – including the scientists conducting the trials, doctors, oncology nurses, and patients – in not only discussing clinical trials, but also the important concept of informed consent where patients have a full understanding of the trial, willingly decide to participate, and continue their consent through the duration of the trial.

“We all need to work together,” Gerber said. “It should be patient-centered, but it takes all of us.”

While Gerber was referred to a clinical trial by her care team, there are also other resources that oncology nurses can discuss with their patients, including websites for major cancer centers, and other resources such as the Susan G. Komen Foundation, breastcancer.org, and the American Society for Clinical Oncology’s (ASCO) website.

Clincaltrials.gov hosts information for all cancer clinical trials in the United States. And while Gerber mentioned that some have said that the website is not patient-friendly, it is uplifting to see the amount of research that is being conducted.

“Despite all the criticism, around this site, it’s pretty phenomenal. There are over 4500 studies on breast cancer. That’s fantastic for all of us,” she said.

But despite all these resources, there are also barriers that patients face when it comes to enrolling in clinical trials. They range from personal perceptions – including lack of awareness, distrust, and financial concerns – to logistical problems, such as the need for childcare for additional appointments and transportation issues.

“My big issue was that I needed to get home for the 11 a.m. school bus,” Gerber, who had 2 young children when she was diagnosed with early-onset breast cancer, said.

Another common assumption is that patients can only enroll in a clinical trial if they are being treated at an academic institution. But Gerber stressed that this is not the case.

“Great trials are already happening in the community setting,” she said.

Gerber hopes that by increasing engagement in clinical trials and engaging community leaders as clinical trial ambassadors, more patients can overcome these barriers. From both a professional and personal standpoint, adding that she has a goal of educating people about clinical trials.

“I believe let’s walk the talk,” she said. “One of the ways that we can overcome barriers is to have somebody patients can trust – another patient like them who enrolled and can talk about the experience.”

Cancer Clinical Trials at Roper St. Francis in Charleston, SC

SCOR member Roper St. Francis Healthcare provides expert diagnosis and treatment for many different types of cancer. Each patient’s cancer journey is unique, and our highly skilled, multidisciplinary team of cancer experts take a personalized approach to each patient’s particular disease and situation.  In this video, oncology/hematology specialist Dr. Brian Lingerfelt explains how patient participation in Roper St. Francis Healthcare’s innovative clinical trials is improving cancer care.  Find more information about cancer clinical trials in your community HERE.

Understanding Clinical Trials

It’s Pancreatic Cancer Clinical Trial Awareness Month, and this short video from the National Pancreas Foundation gives a great overview of what clinical trials are, how they are conducted, and why they are important for patients with diseases like pancreatic cancer. It provides a thorough overview of study design, eligibility criteria, informed consent, safeguards, different phases of clinical trials, and the potential benefits and potential risks of participation. Find out more about cancer clinical trials HERE.

 

Stage IV Survivor’s Ongoing Clinical Trial Success

From Pancreatic Cancer Action Network
By Kristin Reynolds, Jan. 14, 2020

Pancreatic cancer clinical trial participant Earl Groce at his son's wedding

Earl Groce with his wife, Juanita, at their son’s wedding. Groce was best man.

Earl Groce couldn’t believe it when his doctor told him that he had pancreatic cancer.

It was stage IV.

“I’ve always had pretty darn good luck,” he said to the doctor. “I believe it’s just run out.”

Today, four-plus years later, he feels differently.

Earl Groce enjoys time with his family, including three grandchildren.Groce has been a part of a clinical trial since his diagnosis, and the results, he said, “have been tremendous.”

Just recently, his MRI and CT scan (he’s had around 25 of each) revealed continued good results – no sign of cancer. His CA 19-9 levels remain in a normal range – also a good sign.

At 72, Groce has had 98 rounds of chemotherapy through a clinical trial for CPI-613, a targeted therapy aimed at cancer cell metabolism. He receives the test drug in addition to FOLFIRINOX, a combination of three chemotherapeutic agents.

Pancreatic cancer patients who participate in clinical research have better outcomes. Every treatment available today was approved through a clinical trial. The Pancreatic Cancer Action Network (PanCAN) strongly recommends clinical trials at diagnosis and during every treatment decision.

Groce joined the clinical trial as a phase I study participant. The study is currently in phase III.

“If you get a chance to enroll in a clinical trial, please consider it,” is Groce’s message to others fighting pancreatic cancer. “Do it for your sake and the sake of future patients.”

Since the diagnosis, Groce, a grandfather of three (with another one on the way), has watched them “get four years older,” stood beside his son as the best man at his wedding, taken a slew of road trips, bought a condo on an N.C. beach and celebrated 51 years of marriage to his wife Juanita.

“I want to see thousands of pancreatic cancer patients have the same great life after diagnosis that I’ve had,” he said.

He knows his diagnosis is not cause for celebration, but being alive certainly is.

“Nothing changes your attitude like being told, ‘You are going to die pretty soon.’

“So every time someone says to me, ‘Have a good day!’ I respond that EVERY day is a good day.”

FirstHealth Clinical Trials Make Impact

Cancer clinical trial participant at FirstHealth of the Carolinas in Pinehurst, NC

Clinical trial patient Ken Hill with Dr. Charles Kuzma and nurse Pam Mason. Ted Fitzgerald/The Pilot

From: ThePilot.com, Jan 7, 2020
by Laura Douglass

Tucked into a corner of FirstHealth’s Outpatient Cancer Center in Pinehurst, Dr. Charles Kuzma’s unassuming office belies the important work that begins here.

As the institutional principal investigator of clinical trials for FirstHealth of the Carolinas, he spends his days collaborating with numerous doctors and four department coordinators who manage up to 30 active clinical trial studies involving hundreds of patients.

“The advanced medical treatments that we enjoy today are thanks in part to medical research,” Kuzma said. “Patients elect to participate in a research study that not only could improve their health or condition, but also could improve health care in the future for many others.”

In 2019, 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.

“Everything we do with patient care is based on another patient going before them in the treatment.”

Advancing the Science

FirstHealth initiated its clinical trials program in the early 1990s with one doctor and one coordinator. But interest had waned prior to Kuzma’s arrival.

A medical oncologist/hematologist and U.S. Navy veteran, he was recruited by FirstHealth in 2009 to help reinvigorate the program. At the time, there were only three patients actively enrolled.

One of his earliest goals was to bring FirstHealth into the Southeast Cancer Consortium, a community network of private practices and public hospitals involved in cancer clinical research.

“There is strength in numbers,” Kuzma said, noting it can be challenging for a single institution to recruit enough patients for a study.

The National Cancer Institute (NCI) sponsors most of the clinical trials at FirstHealth Moore Regional Hospital. Pharmaceutical or drug companies also sponsor clinical trials, while others may be sponsored by cancer research facilities at UNC-Chapel Hill and Duke University.

FirstHealth’s trials focus primarily on breast cancer, lung cancer, colon cancer and prostate cancer.

“You don’t make money with this. What you do is advance the science and outcome of your patients,” Kuzma said. “But we also have a responsibility to the hospital to not be a money loser. It’s not about making money, but we try not to lose too much.”

However, “success breeds success,” and smaller trials conducted by FirstHealth attracted interest for bigger trials.

“With any clinical research you have to make sure the data is valid because it could lead to change of standard of care,” Kuzma said. “We are held to a very high standard to make sure the data that is turned in is pristine.”

Currently, there are 22 clinical trials underway at FirstHealth dedicated to cancer research, while the hospital as a whole is conducting approximately 10 non-oncology trials for other medical conditions.

Patients include folks like Pinehurst resident Ken Hill, who discovered he has chronic lymphocytic leukemia (CLL) in 2012, when he was being treated for skin cancer.

When a routine blood scan three years later revealed a saturation of cancer cells, Kuzma recommended Hill for a clinical trial of a drug that could be added to his infusion regimen. The sponsor of the trial, Alliance for Clinical Trials in Oncology, funded the cost of the treatment.

Within a few months, bone marrow scans began tracking a remarkable reduction in the cancer cell saturation in Hill’s blood.

Those positive outcomes have continued as part of Hill’s ongoing treatment in the clinical trials program. In addition, he and his wife, Betty, now serve on a peer support advocacy group sponsored by the Southeast Clinical Oncology Research Consortium.

One of the horrible things about cancer is it paints you in a corner,” said Kuzma. “This program gives patients another opportunity to improve.”

Clinical trials team at FirstHealth of the Carolinas in Pinehurst NC

First Health clinical trials team. L-R: Tina Thompson, Regulatory Coordinator Erin Anderson, Study Coordinator Dr. Charles Kuzma, Institutional Principal Investigator Pam Mason, R.N., Study Coordinator Natalie McBride, MHA, RRT, Study Coordinator Amy Boyette, R.N., Study Coordinator Julie Williams, Ph.D, MHA, Study Coordinator. Ted Fitzgerald/The Pilot

Importantly, patients in a clinical trial are all volunteers and they can expect to receive the current standard of care or a new treatment that the study sponsors believe is as good as or better than the standard of care.

Kuzma added that having a robust clinical trials program is also in the best interests of FirstHealth.

“Each clinical trial takes you farther down the road. For example, breast cancer treatment is so different now than in years past because some patients were selfless in their approach.”

Clinical trials are conducted in stages that are ranked within four progressive phases — from early investigative work to continuing research into long-term use and side effects.

Kuzma said most clinical trials conducted at FirstHealth are classified as Phase II or Phase III studies.

A patient’s eligibility for a clinical trial is determined by a participating physician and research nurse, but the final decision whether or not to participate is made by the patient themselves.

“Every trial has different eligibility criteria. And patients who go into a trial are generally healthier and a bit more motivated,” Kuzma said.

But it can be a scary process for patients because the selection is randomized to eliminate bias.

“There is an equal chance for the patient to be on either side of the treatment question. The patient doesn’t have a say and the hospital does not have a say,” he said. “We encourage participation but we are not insistent on it.”

Patients and their families seeking more information about clinical trials at FirstHealth of the Carolinas can visit www.firsthealth.org/reference/clinical-trials or talk with their own physician.