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Nicole Goolsby is a ‘Hope Cheerleader’ for Patients in Clinical Trials

May 20, 2020/in Cancer Care Delivery Research, Clinical Trial, NCORP
By Page Leggett
May 18, 2020

Nicole Goolsby took a circuitous route to healthcare. There was one foray into cosmetology; another led her to computer programming.

But eventually, she became an oncology clinical research coordinator – an advocate for patients participating in highly-regulated clinical research trials – for Novant Health. “When you have a calling in life,” she said, “the calling prevails.”

Nicole and dad

Nicole Goolsby and dad. Marion “Mickey” Slomka was a Polish immigrant born in a German displacement camp. He obtained a degree in business administration and went on to own and operate carnival games.

Nicole Goolsby and dad. Marion “Mickey” Slomka was a Polish immigrant born in a German displacement camp. He obtained a degree in business administration and went on to own and operate carnival games.

Although she didn’t know it then, it was her father’s 1993 death from metastatic adenocarcinoma to the lungs that set Goolsby on her path. She was 14. “I remember asking, ‘Is there nothing more you can do to help him?’” she recalled.

Goolsby began to care deeply about the patients she met when she worked as a night clerk at a small hospital in Yadkinville, North Carolina. That job led to a role as a surgical medical assistant to breast cancer patients – a job she had and loved for 17 years.

In 2019, Goolsby took on what could be the role of a lifetime. She wanted to give hope to cancer patients and their families. “It’s my goal to bring a smile and some laughter to all those I come in contact with,” she said. She calls herself a “hope cheerleader.”

Goolsby recruits, provides guidance to and follows up with patients who have been identified as candidates for national and international cancer care delivery research (CCDR) trials. That’s one of a number of types of cancer trials Novant Health is part of. Others include:

  • Medical oncology (treatment trials)
  • Cancer control trials
  • Medical device trials
  • Radiation oncology trials
  • Surgical oncology trials
  • Symptom management trials

Novant Health oncologists provide clinical research coordinators basic background information on patients who may meet the criteria for a trial. (Even this basic information is regulated by a special team called an Institutional Review Board, or IRB.)  These trials may involve partnerships with other hospitals, research universities, pharmaceutical companies and more – but the patients who volunteer are the very heart of the program.

Goolsby helps determine who’s a match and reports back to the doctor, who then talks to patients who have been vetted. Those who want to participate meet a coordinator (by phone, in the age of COVID-19) to review what’s involved and decide if and how to proceed. “I present the facts and make sure patients understand them,” Goolsby said.

If a patient gives informed consent, it’s because Goolsby – or a teammate – gave them all the information necessary to make a decision, including all the potential risks and possible benefits.

She assures them that, should they decide to participate, their private health information will be kept private. She also has to make sure they understand that the trial they’re participating in may not benefit them. “But it will benefit someone,” she assures. Research through clinical trials can lead to new ways to prevent, detect or treat diseases, including cancer. Clinical trials also help scientists develop new ways to use existing treatments or new surgical procedures or devices.

COVID-19 altered how Goolsby and other coordinators did their jobs. They’ve always relied on face-to-face meetings with patients – some of whom are scared by their diagnosis or unfamiliar with clinical trials. COVID-19 has made the world even more uncertain and forced the team to rely on just the phone. They have to establish a personal connection without looking people in the eye.

Nicole Goolsby books

Not being able to read a patient’s body language and facial expressions was tough, she said. She often relies on non-verbal cues to determine if a patient is confused, reluctant, scared.  Whenever possible the overseeing physician was present for the consenting process,” she said.

Goolsby and team were allowed back in clinics, with certain restrictions, to see patients in person earlier this month.

While most people may think clinical trials involve experimental treatment, that’s only a small part of the picture. The CCDR trials Goolsby is involved in involve questionnaires and sometimes lab work. That’s it. And trials are not just for patients with late-stage cancer. “There are trials for people with Stage I cancer,” Goolsby said. “There are even trials for pre-cancer.”

One such trial Goolsby assisted in was for lung cancer screening. The 50 participants from Novant Health were smokers. They answered a series of four questionnaires over a six-month period. At the end of the trial, four of them had quit smoking – a fantastic, unexpected outcome.

Goolsby sees part of her role as helping to erase any stigma associated with clinical trials. Sometimes, when people think of clinical trials, they think of guinea pigs. “The brave people who participate are not guinea pigs,” she said. “They are heroes.” People who participate in clinical trials are advancing the science of medicine for all of us.

Patients who take part have Goolsby or a teammate as a resource throughout the trial and beyond, if there are follow-ups needed. At any given time, Goolsby could be serving as coordinator/advocate for more than 90 patients.

When she took the job, she remembered how she felt as a teenager who’d lost her father.

“At 41, I now recognize that had I never lost my father to cancer, I would not have this amazing opportunity to provide hope, joy and drive to encourage these warriors to fight their battle,” she said. She often reminds them: “We’ve got to hold on to the most powerful weapon we have – faith and hope.”

Not a day goes by that she doesn’t think of her dad while helping her patients. “Every day, I think, ‘All right, Dad. Let’s go kick some cancer butt.’”

From Novant Healthy Headlines

https://southeastclinicaloncology.org/wp-content/uploads/2020/05/Nicole-Goolsby-e1589994263982.jpg 225 300 BCeditor https://southeastclinicaloncology.org/wp-content/uploads/2018/06/SCOR-Southeast-Clinical-Oncology-Research_Logo.png BCeditor2020-05-20 13:01:092020-05-20 13:05:03Nicole Goolsby is a ‘Hope Cheerleader’ for Patients in Clinical Trials

WILL COVID-19 BOOST CLINICAL TRIALS AWARENESS?

May 20, 2020/in Clinical Trial, Covid-19, NCORP

From: www.instituteforpatientaccess.org
May 18, 2020

This piece from the Institute for Patient Access gives excellent insight into the massive effects, both positive and negative, the COVID-19 crisis has had on clinical trials.  Although in many cases, resources have been diverted to focus on finding a treatment and possible vaccine for the virus, it is quite possible that an increased awareness of the importance and necessity of clinical trials has been realized across the country and the world. 

This year’s Clinical Trials Awareness Week falls squarely in the midst of the COVID-19 pandemic. The week’s theme, “Clinical Trials During a National Public Health Emergency,” explores how the coronavirus demands and, in some cases, also disrupts clinical research. It also prompts an important underlying question: Once the pandemic subsides, will the public retain a greater awareness and appreciation of clinical trials?

Clinical Trials & the Coronavirus

More than 100 potential novel coronavirus vaccines are being developed by research teams around the globe. In the United States, pharmaceutical companies, university researchers and government agencies are working together to find a vaccine. Meanwhile, the FDA recently approved existing drug remdesivir for emergency use in treating people infected with COVID-19.

But finding effective COVID-19 treatments takes time. Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Disease, has stated that it will take at least a year or more to provide a workable vaccine.

While this effort moves forward, clinical trials investigating potential medications for non-coronavirus related diseases are being pushed to the back burner. Reporting from NPR indicates that 440 clinical trials, involving as many as 200,000 people, have been suspended because of the coronavirus outbreak. One-quarter of the trials put on hold were exploring cancer treatments, with research on strokes, dementia, and other serious conditions stalled as well.

Clinical trials during the pandemic pose a number of challenges. Researchers and sponsors must decide if enough staff are available, and if visiting health care facilities is worth the risk of virus exposure for trial participants. Meanwhile, data obtained from trials will take longer to develop, with radiology suites and other offices closed.

Clinical Trials Awareness After COVID-19

But the COVID-19 pandemic could also have positive long-term implications for clinical trials.

In years past, people often have had little awareness of clinical trials until they or a family member needed to join one. The lack of knowledge makes clinical trials difficult to enroll and conduct, even under normal circumstances. Over one-third of trial sites fail to meet their enrollment goals, with more than one site in 10 unable to enroll even a single patient.

By elevating public awareness of clinical trials, the COVID-19 pandemic could alter that trend.

If the coronavirus outbreak offers any silver lining, perhaps it’s that the country’s experience could stimulate public interest and participation in future trials, ushering in a period of robust research that yields meaningful treatments for patients, families and communities.

Finding a novel coronavirus vaccine will save lives. But it could also mark the beginning of a greater public awareness of the importance of clinical trials.

https://southeastclinicaloncology.org/wp-content/uploads/2018/06/SCOR-Southeast-Clinical-Oncology-Research_Logo.png 0 0 BCeditor https://southeastclinicaloncology.org/wp-content/uploads/2018/06/SCOR-Southeast-Clinical-Oncology-Research_Logo.png BCeditor2020-05-20 12:32:262020-05-20 12:32:26WILL COVID-19 BOOST CLINICAL TRIALS AWARENESS?

Will Covid-19 Boost Clinical Trials Awareness?

May 18, 2020/in Cancer Clinical Trial, Clinical Research, Clinical Trial, Covid-19, Uncategorized

From Institute for Patient Access
May 18, 2020

This year’s Clinical Trials Awareness Week falls squarely in the midst of the COVID-19 pandemic.  The week’s theme, “Clinical Trials During a National Public Health Emergency,” explores how the coronavirus demands and, in some cases, also disrupts clinical research.  It also prompts an important underlying question: Once the pandemic subsides, will the public retain a greater awareness and appreciation of clinical trials?

Clinical Trials & the Coronavirus

More than 100 potential novel coronavirus vaccines are being developed by research teams around the globe.  In the United States, pharmaceutical companies, university researchers and government agencies are working together to find a vaccine. Meanwhile, the FDA recently approved existing drug remdesivir for emergency use in treating people infected with COVID-19.

But finding effective COVID-19 treatments takes time. Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Disease, has stated that it will take at least a year or more to provide a workable vaccine.

While this effort moves forward, clinical trials investigating potential medications for non-coronavirus related diseases are being pushed to the back burner. Reporting from NPR indicates that 440 clinical trials, involving as many as 200,000 people, have been suspended because of the coronavirus outbreak. One-quarter of the trials put on hold were exploring cancer treatments, with research on strokes, dementia, and other serious conditions stalled as well.

Clinical trials during the pandemic pose a number of challenges.  Researchers and sponsors must decide if enough staff are available, and if visiting health care facilities is worth the risk of virus exposure for trial participants.  Meanwhile, data obtained from trials will take longer to develop, with radiology suites and other offices closed.

Clinical Trials Awareness After COVID-19

But the COVID-19 pandemic could also have positive long-term implications for clinical trials.

In years past, people often have had little awareness of clinical trials until they or a family member needed to join one. The lack of knowledge makes clinical trials difficult to enroll and conduct, even under normal circumstances. Over one-third of trial sites fail to meet their enrollment goals, with more than one site in 10 unable to enroll even a single patient.

By elevating public awareness of clinical trials, the COVID-19 pandemic could alter that trend.

If the coronavirus outbreak offers any silver lining, perhaps it’s that the country’s experience could stimulate public interest and participation in future trials, ushering in a period of robust research that yields meaningful treatments for patients, families and communities.

Finding a novel coronavirus vaccine will save lives. But it could also mark the beginning of a greater public awareness of the importance of clinical trials.

https://southeastclinicaloncology.org/wp-content/uploads/2020/05/Covid-and-clinical-trials.jpeg 1025 1536 BCeditor https://southeastclinicaloncology.org/wp-content/uploads/2018/06/SCOR-Southeast-Clinical-Oncology-Research_Logo.png BCeditor2020-05-18 11:24:252021-04-12 11:38:54Will Covid-19 Boost Clinical Trials Awareness?

May is Skin Cancer Awareness Month

May 15, 2020/in Cancer, Cancer Clinical Trial, Skin Cancer

May is Skin Cancer Awareness Month SCOR NCORPThere are over 5 million cases of skin cancer diagnosed in the United States annually, making it the country’s most common cancer.  It is also one of the most preventable forms of cancer.  Approximately 90 percent of non-melanoma skin cancers and 85 percent of melanomas are associated with exposure to harmful ultraviolet radiation from the sun.  We can help save lives by knowing and sharing the facts about the dangers of unprotected sun exposure and by being knowledgeable of the skin cancer warning signs.

Fortunately, dermatologists can successfully treat most cases of early-stage, non-melanoma skin cancer in an outpatient setting, however there are some instances in which more aggressive treatment is needed. Patients with more advanced skin cancer that does not respond well to traditional treatment can consider clinical trials in which promising new treatment strategies are being studied. Thanks to the work of researchers and clinical trials, we have more skin cancer treatment options now than ever.

For instance, research and clinical trials have been instrumental in the development of immunotherapy as a successful treatment for melanoma and cutaneous squamous cell carcinoma.  However, new treatment options for these and other skin cancers are urgently needed, and there are currently several clinical trials available that specifically target non-melanoma skin cancers.

People who participate in skin cancer clinical trials help researchers learn more about skin cancer and develop improved treatments. Just as the treatments we receive today are based on the results of past clinical trials, we know that tomorrow’s treatments depend upon what we learn in clinical trials today. To learn more about skin cancer clinical trials near you, visit us HERE.

Sources:  skincancerfoundation.org, cancer.gov

https://southeastclinicaloncology.org/wp-content/uploads/2018/06/SCOR-Southeast-Clinical-Oncology-Research_Logo.png 0 0 BCeditor https://southeastclinicaloncology.org/wp-content/uploads/2018/06/SCOR-Southeast-Clinical-Oncology-Research_Logo.png BCeditor2020-05-15 13:46:562020-05-15 13:46:56May is Skin Cancer Awareness Month

The Pandemic of COVID-19 and its Effect on Clinical Trials in the Community

May 4, 2020/in Bon Secours Richmond, Clinical Trial, Clinical Trial Accrual, Covid-19
James Adkins, SCOR co-principal investigator

James N. Atkins, MD Bon Secours Cancer Institute at St. Mary’s & Co-Principal Investigator, SCOR NCORP, Richmond, VA

This story is part of The Cancer Letter’s ongoing coverage of  COVID-19’s impact on oncology. 

This pandemic has affected a lot of people, both physicians and patients, physically as well as emotionally.

There are patients who have become afraid to come into the office to see the staff for fear that they would contract the virus. Our patients seem to have more depression, which may stem from a lack of social interaction.

We have all had our practices turned upside-down, we have gone from face-to-face visits, which we love, to computer-to-computer, or phone-to-phone visits. We have seen physician reimbursement plummet and colleagues stress about their ability to run a private practice.

Physicians have been concerned about their ability to pay the bills as well as their own mortality from this invisible enemy.

We are seeing PTSD in practitioners.

This virus, like cancer, has turned a lot of lives upside-down, and perhaps has shown us what our patients face on a daily basis.

Some patients whom I have seen have been treated on clinical trials in large cities and have been told that they cannot come back to the city for therapy due to the COVID lockdown. They have been referred to our communities to get their clinical trial therapy.

We are treating patients on clinical trials, but they are on trials that we do not have open. This would have been unheard of a few weeks ago. It would be a major protocol deviation, but should it be?  What can we learn—and what should we learn—from this pandemic when it comes to clinical trials and audit time?

Getting patients in to be seen on time (as per protocol) has been more difficult due to patients’ fear about going to the hospital, a doctor’s office or the concerns about social distancing on the way to or in the office.

In the past, we could get tests done when we wanted them—within a day or two. Now, a CT scan will have to be classified as STAT in order to get it done on a certain date.

We would never had ordered it STAT in the past, as it may cost more; but now we have to. With COVID, the x-ray departments have changed their protocols so as to have more time available for COVID patients and to conserve supplies. So our patients who need x-rays are delayed.

Some of our nursing staff may have been furloughed or redeployed due the pandemic as the hospitals are losing money and they are trying to maintain a balance sheet that is already negative.

One of the offices in our NCORP have had their staff furloughed, with just a manager left behind, 6 of 19 offices are trying to do 75% to 90% of their work remotely, and 10 of 19 continue to work in-house.

There has been a significant decline in NCTN accruals to clinical trials over the past month nationally. It also seems that there has been a significant decrease in new cancers over the past month as well. The decrease in cancers is probably due to people being afraid to come to see a doctor—or the procedures to diagnose the cancer is considered elective.

Some of the practitioners, doctors included, are afraid to see patients for fear that they may get the virus from the patients and then get sick or die. We are seeing more patients with virtual visits, and this is good in that it does decrease the exposure of our patients to others. However, this makes documenting for clinical trials more difficult.

Those of us treating patients worry about deviations from protocols and the protocol violations that then occur.

The good thing is that there are people in the clinical trial organizations and the NCI who do understand what’s going on. We believe that the problems of the pandemic will be considered when it is audit time.

We are having problems getting procedures done like colonoscopies for iron deficiency in the older population, and needle biopsies of lung lesions when we need them. We have found that we have to be more insistent on what we want and when we want it, as others may not understand.

I had a patient who needed a lung biopsy after her third cycles of therapy, and radiology was not very happy, because we already had a diagnosis of lung cancer, we had not been clear enough in our request.

We are also having problems getting tests done within the eligibility time window, just getting pulmonary function tests or a Cardiac Echo may take time.

What can we learn from this pandemic? What can we do to make changes that will improve clinical trials in America? Can we have a system where physicians are approved by some organization as being physicians that have demonstrated good practice with clinical trials and those so designated be allowed to work across trials from different sites?

It seems like we have seen a significant drop in accrual to clinical trials over the past year or two, as trials became more precision-based. COVID has just made this worse.

I fear that we are getting down much closer to 1% of adults going on trials not the 3% of the past. Should a patient be able to go 200-400 miles away to get started on a trial and then be allowed to get some or all of their follow-up treatment closer to home if it is agreeable with all the providers?

I think it is worth considering.

The easier we make it for a patient to go on a clinical trial and the easier we make it for their follow-up, the better we will do with accrual and changing the therapy for cancer.

If this is a time for change, then we need to re-evaluate the barriers for patients going on trial.

These may range from a lack of clinical trial training in our training programs, to physician apathy and burnout, ability to open trials due to lack of staff, patient trust, and financial support just to name a few.

We have to decide how important it is and whether we want to try to fix it—or whether the status quo is acceptable.

Copyright (c) 2020 The Cancer Letter Inc.

https://southeastclinicaloncology.org/wp-content/uploads/2018/06/SCOR-Southeast-Clinical-Oncology-Research_Logo.png 0 0 BCeditor https://southeastclinicaloncology.org/wp-content/uploads/2018/06/SCOR-Southeast-Clinical-Oncology-Research_Logo.png BCeditor2020-05-04 14:18:142020-05-04 14:38:25The Pandemic of COVID-19 and its Effect on Clinical Trials in the Community

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T: (336) 448-1417
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