Medical Hero Story: Desiree De Luca-Johnson & Breast Cancer

“I am a lawyer, my husband is a pathologist, and I had no idea that there were hospitals that just treated cancer,” says Desiree De Luca-Johnson, an attorney, breast cancer survivor and patient advocate. At the age of 40, just when she was ready to go back to work after staying home with her young children, Desiree was diagnosed with breast cancer. Desiree’s road to being a clinical trial participant is reflective of her legal training. “I made a plan. I had a white board. I decided that if ‘A’ happens, then we would move on to ‘B’. I’m passionate about clinical trials.”

Desiree was diagnosed while living in a military community in Virginia, and her husband was deployed. “I was exhausted, and literally crawling upstairs to put my kids to bed,” Desiree recalls. Her oncologist at the time was a military physician and the treatment plan recommended for Desiree was conservative in nature. She was not told about clinical research as a healthcare option.

“I got 200 pages of where I could get free makeup and wigs, and not one page on clinical trials,” says Desiree. “I discovered that oncologists have different attitudes about treating cancer and I wish someone had told me about this. My oncologist was not aggressive about different treatment options.” Desiree recalls she was willing to deal with a higher level of side effects when her doctor told her she had an 80%/20% chance of survival.

“I was suicidal because of the anxiety. I found out (in addition to the breast cancer), I had a benign brain tumor,” says Desiree.

When she posed a question about clinical trials, Desiree’s doctor told her she was not sick enough to be in a clinical trial.

Desiree’s background as an attorney had honed her research and investigative skills. She decided to take definitive action.

“I made lists of cancer hospitals. I investigated their websites. I learned about ClinicalTrials.gov, which is a hard website to navigate. My husband was opposed to me doing a clinical trial, so I was doing this research all alone. But it was keeping me alive,” says Desiree. (Desiree’s husband ultimately embraced her decision to participate in clinical trials). “After 40 or 50 hours of work, I found BreastCancerTrials.org, where I found 6 clinical trials I might be eligible for. We have a saying in the law. When you’re repeating your results, you have done your research. I was ready to apply to clinical trials,” says Desiree.

Her oncologist in Virginia was not supportive of Desiree’s decision, and voiced a level of concern about clinical trial participation. Undeterred, Desiree pursued clinical research options and other avenues for her health and wellness.

“The most important thing about choosing to enroll in a clinical trial, for me, were childcare and the affiliated travel costs,” says Desiree. “I became my own doctor, in a sense. I read that doing yoga was good when you have cancer, so I did yoga. I read that exercise was good, so I hired a health coach,” says Desiree.

And, she participated in clinical trials. “I did an early-stage trial,” says Desiree. “The big barrier, again, was childcare. The navy has a program so my husband didn’t have to deploy during my treatment, so he could take care of our children.”

Desiree’s sister, who lives in Boston, recommended looking at Massachusetts General Hospital for relevant clinical trials to join. Desiree enrolled in a one-year treatment clinical trial. At the end of this clinical study, it was deemed a negative trial, meaning that the results demonstrated that the new treatment was inferior to standard treatment. (1) Overall, the experience was still a positive one for Desiree.

“I felt safer in a clinical trial because I had a better relationship with my research oncologist and oncology nurse in Boston. We were all up to date on the same research,” says Desiree. “I was grateful to be at a top research hospital. I was able to feel safe for a year – it gave me some time to breathe and research my options.”

“Through my clinical trial participation, I got access to other treatments for other conditions, such as bone density, and I was able to access other clinical trials,” says Desiree. Her research oncologist became her primary oncologist.

“Now I am in a trial to monitor for re-occurrence and I can make an action plan for quality of life,” says Desiree.

“Before participating in clinical research, every single day my first thought was, how will I know if my cancer has returned? Now I wake up and feel free,” says Desiree.

Desiree and her children have relocated to her home state of Vermont, in order to be closer to Massachusetts General Hospital, the clinical trial and family. “The relationships really matter,” says Desiree.

Desirae’s clinical research journey has brought her full circle, professionally. She currently works full-time at BreastCancerTrials.org as Outreach and Operations Manager.

Desiree advises people considering clinical research that, “When it comes to your oncologist, it’s a fiduciary relationship. It was my job to know the consequences of the decisions I was making to help them reach their goals. You have to be your own best advocate. No one is going to care as much about your life as you do.”

To search for medical conditions in a specific location visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

Sources:

  1. https://www.rxlist.com/negative_clinical_trial/definition.htm)

Medical Hero Story: Phyllis Kaplan & Type 1 Diabetes

Phyllis has a vague recollection of waking up in a hospital with tubes attached to her body, and a distinct memory of saying “Take the tubes out!”. At the age of two, she was diagnosed with type 1 diabetes, an autoimmune disease, typically diagnosed in childhood, but can manifest at any age. Diabetes has led Phyllis on a path from patient to advocate, to clinical research participant.

“I have been an advocate since I was 12 years old. It started in junior high school, in a gym class when the teacher made me take off my medical alert bracelet, due to a ‘no jewelry in gym class’ rule,” says Phyllis. When she went to retrieve the medical bracelet from the gym locker after class, she discovered it had been stolen. This incident spurred Phyllis to write a letter to the town Superintendent of Schools, demanding its replacement and a change in the rule to allow medical-related items to be worn. By the time the letter had been delivered, the bracelet had been anonymously returned to the school’s Lost & Found box. Phyllis was allowed to wear the bracelet moving forward.

The most important thing to understand about type 1 diabetes, says Phyllis, is “The patient or caregiver has to make so many decisions about the disease, every day with no break. With diabetes, every day is different.”

Type 1 diabetes develops quickly. The body’s immune system attacks and destroys beta cells in the pancreas that create insulin. The body cannot produce insulin without these beta cells. A peptide hormone, insulin helps your body metabolize fats, proteins and carbohydrates through glucose (a type of sugar) that is released into the bloodstream when you eat food. The glucose is then absorbed from the blood in the liver, fat and skeletal muscle cells. Type 2 diabetes develops more slowly, over time. The body produces insulin, but cannot use it effectively. (1)

Decisions about how much medication to take is based on many variables including food, exercise, change in weather, change in personal schedule and stress.

“That’s why education is so important,” says Phyllis. “If I am going to exercise, I have to plan ahead, at least a couple of hours before, as exercise impacts blood sugar. There are so many hidden things to know about diabetes that impact your decisions.”

Phyllis has participated in three clinical trials, two for rescue medications for severe hypoglycemia and one for a medical device. “As a longtime advocate, I felt that participating in a clinical trial was the ultimate form of advocacy,” Phyllis explains.

“The trials were very different from each other,” says Phyllis. “Two of the three were very easy. One involved two full days in clinic, and that was really hard, with 9 hours of ongoing blood tests. Those were physically difficult days, but worth it. The other two clinical trials were less invasive.”

When considering the 2-day in-clinic trial, Phyllis and her husband reviewed the protocol together. “I wouldn’t participate without consulting him,” says Phyllis. He accompanied her to the two in-clinic days, to be with her during the 9 hours of ongoing tests and to lend additional support.

When asked if she faced any concerns from family or friends about her clinical research participation, Phyllis says “No, quite the opposite. People were really interested in the ‘why’ of what I was doing and what the outcomes were.” Phyllis didn’t seek any advice from patient advocacy organizations, because of her own experience as an advocate. She is a brand ambassador with Medtronic Diabetes to share her experience with their medical device and  also volunteers with JDRF (Juvenile Diabetes Research Foundation), and ADA (American Diabetes Association)

Phyllis advises individuals considering clinical research participation to “Ask all the questions you have when meeting with the nurse/study lead. No question is too silly. Read the protocol and informed consent, which can be confusing. Use a highlighter to mark items in the protocol or use Post-Its to make notes. Keep asking questions throughout the course of the study. At times the research staff may not always be patient-centric, and if you’re not getting the answers to your questions, ask to speak with someone else on the study team. Be your own best advocate and keep pushing. Researchers are not always prepared to answer patients’ questions. If something doesn’t sit well with you, voice it.”

Phyllis’ advocacy work has also led her to CISCRP, where she is Senior Manager, Events & Community Engagement. CISCRP’s mission to informing and engaging patients and the public about the importance of clinical research resonated with her. Phyllis leads CISCRP’s Aware for All free clinical research educational programs, which have pivoted from in-person, city-specific events to regional, virtual programs with the advent of the pandemic. You can learn more about AWARE for All here.

Her experience as a clinical trial participant has strengthened Phyllis’ commitment in sharing information about the importance of clinical trials to everyone. Phyllis is adamant and passionate about participating in clinical research again if the opportunity presents itself, reiterating, “Absolutely. Without clinical trials new treatments can’t happen and without clinical trial participants, clinical trials can’t happen.”

To search for medical conditions in a specific location visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

Sources

The Facts About COVID-19 Vaccine Clinical Trials

Are you still deciding whether to get the COVID-19 Vaccine? To help you make the decision that you believe is best for you, your family, and your community, we made an infographic about the role of clinical trials in the development of the vaccines. 

Relevant resources:

  • A list of resources used to develop the COVID-19 vaccines infographic
  • Recognizing Research Professionals Who Participated in COVID-19 Trials Video
  • CISCRP’s Education Center

If you are interested in licensing this infographic or other CISCRP content for use within your organization or in your public-facing website, please contact Ellyn Getz at egetz@ciscrp.org.

The Importance of Clinical Research in Underserved Communities

The importance of clinical research is widely recognized, and while many decide to participate in clinical trials, there is a lack of representation of individuals from underserved communities.

In 2019 alone, 46,391 individuals participated in clinical trials that resulted in the approval of 48 new drugs. However, a limited number of study volunteers identified as Black/African American, Asian, and/or Hispanic.

Current efforts to address this lack of representation include a guidance document released by the FDA encouraging pharmaceutical companies to broaden their eligibility criteria. While these efforts are critical in increasing diversity and inclusion in clinical trials, it is equally important to understand how clinical research is viewed from a broad audience.

Every two years, the Center for Information and Study on Clinical Research Participation (CISCRP) conducts a global online study to gather insights on the public and patients’ perceptions and experience with clinical research. Responses from over 12,450 individuals were collected, with representation from many communities, including Black (6 percent), Asian (10 percent), and Hispanic (13 percent) communities.

Importance of clinical research
Individuals across many races and ethnicities acknowledge the value of clinical research studies. Many consider clinical trials to be “somewhat” or “very important” to the discovery and development of new medicines. Additionally, the greatest benefits of participation in clinical research include helping to advance science and the treatment of patient’s disease/condition (26 percent) and the possibility of improving or saving the lives of others with the same condition (21 percent). This highlights how individuals perceive and understand the positive impact participation can have. However, few individuals had recently seen or heard about a clinical trial opportunity.

Where do we look?
Many would begin looking for a clinical trial opportunity by asking their healthcare provider or by using an online resource. For example, over half of Black individuals (52 percent) would use an online clinical trial registry, such as clinicaltrials.gov, and 42 percent of Asian individuals would use an internet search engine like Google. Recommendations from family members are also important to underserved populations in their search for clinical trials.

The relationship between healthcare providers and their patients can be leveraged to increase awareness of and participation in clinical trials. It is important to many that their healthcare provider be aware of ongoing clinical trials in their local communities. Pharmaceutical companies can take an important first step by informing healthcare providers about new clinical trial opportunities in underserved communities. 

Article from our 2020 Clinical Trials Supplement, USA Today. Read more articles here >

Medical Hero Story: T.J. Sharpe, Melanoma Advocate

Why One Cancer Survivor Wants All Patients to Consider Clinical Trials

When melanoma unex­pectedly returned after a successful surgery twelve years prior, T.J. Sharpe was both a husband and a father. Second, third and fourth opinions later, Sharpe was finally offered a life-chang­ing option.

“I wanted a chance to see my children grow up and be the husband and father I could be,” says Sharpe. With the first few doctors, Sharpe’s predicted life expectancy was under two years, which he was determined to extend. “I wanted the best chance at a long-term response.”

Seizing an opportunity
Sharpe was on his fourth oncol­ogist when he was offered his first clinical trial. It was for a new treatment in the form of a pill, and Sharpe was the first patient in the trial. Because it was so new, he ran into bureau­cratic barriers. “I was the first patient to try it, so there were a few stakeholder companies and pharmaceutical companies that I had to wait for over a month to get the contract approved.”

After contacting the stakehold­ers himself to push the paperwork through, Sharpe started the trial. “When you have a family and you are facing mortality, I wasn’t going to miss the chance to see these kids grow up because I was missing part of a signature.”

An incredible recovery
After months on the pill treat­ment, Sharpe’s tumors weren’t responding. But with determi­nation came plan B, and Sharpe started on his second trial. After twelve weeks, he saw a 46 percent reduction in his tumors. Four years later, Sharpe’s only signs of cancer are small spots that have stabi­lized for over two years. Today, he remains in the trial to continue monitoring his response and over­all system.

The results of the clinical trial have so far doubled his life expec­tancy, an accomplishment Sharpe does not take lightly. “Clinical trials should be considered as an option for care in every single case,” he says. For Sharpe, the norm should be to hear your stan­dard care options, but in conjunc­tion with the clinical trial options.

At that point, let the patient and their doctor make the most informed decision. “When it comes down to it, we are all patients at some point, so we should know what all of our options are before making decisions.” 

 

Article from 2017 Clinical Trials Supplement, USA Today. Read full Supplement here >

Medical Hero Story: Jackie Zimmerman, MS Advocate

Jackie Zimmerman is an accomplished entrepreneur, marketing professional, former roller derby league president, and non-profit founder with a “can-do” energy that is clear when you speak with her. She is also a patient advocate for people with multiple sclerosis, also called MS. She herself received the diagnosis during college at the age of 21. In the face of this news, Jackie decided to share her story with others. She later became a participant in clinical research. 

“It was a total surprise  no one in my family has it,” Jackie said. “My first question was…am I going to die? I didn’t know anything about MS. And all the patient-facing documentation was targeted at older individuals.” 

Jackie found this surprising, particularly when she learned that most patients are diagnosed in their twenties. To help process this news, she turned to blogging. 

“Initially, I started a newsletter and then it became a blog. This was before social media, so blogs were how you connected. Blogging got me on the scene of patient advocacy. There are lots of advocates now, but then, there weren’t as many,” Jackie explained. 

Jackie was diagnosed with relapsing remitting MSWith this form of MS, symptoms may “flare up” and then seem to be gone for a period of time. Jackie’s first symptoms were during a flare. At that time, the standard of care was given through an injection. 

“Which was really scary at 21  who likes needles?” Jackie said. “My doctor didn’t provide any guidance. He told me to pick whatever medication I wanted. Today, there are many different options and methods of delivery.” 

Another complication in the treatment of MS is that in terms of symptoms, reactions to medications, and outcomes, no two cases are alike. 

Jackie first participated in an MS clinical trial in 2008. However, she was unable to complete it due to unrelated treatment she was receiving forinflammatory bowel disease, also called IBD. Over a decade would pass before Jackie would join another clinical trial. 

During that time, Jackie founded Girls with Guts, a non-profit to support women living with IBDShe became a more active patient advocate. This led to public speaking engagements and work with healthcare and pharmaceutical companies looking to connect with patients. 

There were 2 factors that steered her back to clinical research as a healthcare option for MS. 

“I asked my neurologist questions, because I wanted to keep abreast of things, particularly because I write about them as an advocate,” Jackie said. “Being part of a patient advisory board for a bio-pharma company was also a huge driver. I understand about clinical research participation and what it means. The only factor this second time was a consideration about the time commitment  it’s about a 25-minute drive away. The trial does offer transportation if you need, which I think is awesome, but I don’t need it.” 

When asked about other influences in her decision-making, Jackie commented, “I’m married, so my husband was involved. He said it’s my choice, but I considered him in the process, and all the things you think about when you’re involved in a partnership. I know how to talk with my friends and family about clinical trials to allay their fears. I know how to position it so as not to scare anybody.” 

Jackie did not consult any patient advocacy organizations for guidance before participating. 

“I’m in the minority here because I know a lot more about clinical trials than the average patient. I knew what questions to ask because I had been on a patient panel and participated in an FDA patient advocacy training. I’ve spent a lot of time learning about trials.” 

Jackie shared some wisdom based on her experience with clinical trial participation. 

“Oh man, there’s so much advice,” Jackie replied, laughing. “I have so many angles. Mostly, don’t be afraid of them. It’s not a last resort for MS in terms of treatment. It’s a way to assist your community and get access to medications, years in advance. You’re so heavily monitored that the potential for anything going wrong is quite low.” 

Jackie would consider participating in future clinical trials. 

“Yes  as long as it fits into my life and it’s not an inconvenience or as long as the potential benefits outweigh the potential inconvenience. I know I have a lot of privilege  I can work from home and make my own schedule. If you’re looking at trials that may not fit into your life, know that there are pharma companies working around participant schedules with office and home visits. If it’s not feasible right now, it doesn’t mean that it will never be feasible.” 

Note: COVID-19 has led many sponsors to offer virtual clinical trials and the use of digital devices to monitor patient progress. CISCRP recently conducted a survey on the impact of COVID-19 on clinical research. Access the reporthere.

To search for medical conditions in a specific location visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

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Medical Hero Story: Jillian McNulty, Cystic Fibrosis Advocate

Born with cystic fibrosis, Jillian McNulty has spent her entire life fighting to stay healthy.

It was only during a clinical trial, when she tried a new medicine called Orkambi, that she met with success. Since then, she’s been fighting for other cystic fibrosis (CF) patients to have access to the drug too.

One of four children, McNulty’s oldest brother had cystic fibrosis and died when he was five-and-a-half. Her prognosis wasn’t good either. When she was born, doctors told her parents she wouldn’t live past her fifth birthday. She’s now 43 and jokes that she has geriatric CF, and is grateful to be alive.

Last hope
Over the years, McNulty has suffered from recurring pneumonia, and sometimes spent 8-9 months out of the year in the hospital.

“I didn’t have a great quality of life,” she recalls, noting her condition was at its worst in 2012 after her other brother, who had special needs, died. She was able to run a marathon before her lung function dropped from the high 50s (percent) to the 30s. She became dependent on IVs and antibiotics.

Fortunately, McNulty qualified for the Orkambi clinical trial, which required her to have lung functioning in the 40s and to not be hospitalized for four or more weeks.

She got emotional when she got the news that she qualified. “I can remember I cried my eyes out because to me this was my last chance, my last hope. Things started to turn after that.”

Though she struggled for the first four months of the trial, at six months her hospitalizations started to decrease. But things took a turn in 2016, when she contracted swine flu and influenza A at the same time. Her lung function was down to 11 percent. Things were grim, but McNulty pushed on.

Changing lives
“Orkambi brought me back from the brink,” McNulty says, explaining it took three months to recover.

She says the drug, which is manufactured by Vertex, works on the underlying cause of CF, a life-threatening disease that affects approximately 75,000 people in North America, Europe, and Australia.

“It’s not a cure but it tweaks the channels so our bodies respond better,” says McNulty, whose lung function is now at 42 percent.

These days, she spends only six weeks a year hospitalized. But now she’s struggling with end-stage kidney disease, another chronic condition she’s had for years, and needs a kidney transplant. But before that, she needs a lung transplant.

Still she’s optimistic about her future and the future of other CF patients.

“It’s all changing. People with CF are going to live so much longer,” says McNulty. “That’s incredible.”

The CF advocate
For the past 11 years, McNulty has campaigned for CF patients in her native Ireland, including lobbying the Irish government to make sure Orkambi and other medications were made available for CF patients. Her campaign was successful and she obtained “pipeline” approval for 10 years of promised accessibility to the drug.

“My friends were dying and I couldn’t stand by and say nothing,” says McNulty, who’s won three awards for her advocacy. “I needed people to see what Orkambi had done for me.”

She’s also been instrumental in campaigns related to the hospitalization of CF patients, helping ensure they get single-unit hospital rooms to prevent them from being exposed to other sick patients while their immune systems were so compromised.

Her advocacy continues on, and she urges patients with CF and other conditions to participate in clinical trials: “It’s worth the chance, it’s worth the risk. It has the potential to transform your life in ways you can’t imagine.” 

To search for medical conditions in a specific location visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

 

Medical Hero Story: Shauna Whisenton

Shauna Whisenton was once an individual living with sickle cell disease (SCD). Now she’s an advocate for better therapies, a cure, and better under-standing of SCD.

Whisenton, now 41, was born with SCD, a painful, inherited disorder where red blood cells are misshaped, restricting blood flow and oxygen to parts of the body.

“It was all going pretty well until I had my third son,” she says. “Then my health started to take a turn for the worse.”

While nursing, she was admitted to the hospital every few weeks and, despite best efforts, was not replenishing enough fluids for her body to function properly and had major organ complications.

Her doctor asked her to consider a bone marrow transplant clinical trial to cure SCD.

Whisenton didn’t believe she could be cured and some members of her family were unsure if she should undergo the treatment. For many in the minority com-munity, there is a fear that medical testing may exploit patients instead of helping them. However, clinical trial oversights ensure safety during participation.

After consulting an SCD patient advocate, she realized, “Although a cure is not guaran-teed, this could be an amazing opportunity. If that is not possible for me, researchers could learn something from my participation to save others.”

Finding a donor

The best chance for a donor match would be a family member. Whisenton lost her parents when she was a child and her sister wasn’t a match; but her 9-year-old son, Dorian, was a 50-percent match.

A successful transplant meant a better life for Whisenton and her family.

“I felt like my children had suffered enough watching my pain,” she says.

Whisenton’s son had marrow extracted from his pelvis bone. It was a one-day procedure for him but the start of a two-year ordeal for his mother.

 
Journey

Whisenton’s journey was tough. She was hospitalized, received anti-rejection medications, and had to undergo was an important part of procedure preparation and recovery. This included coordinated care to provide relief from the symptoms of her disease and the transplant, including pain and detoxing from opiates, but also the physical and mental stress from the procedure.

“It’s important to equip someone who’s received a curative therapy with tools to rebuild their lives during and after recovery,” she says.

Within nine months of receiving the bone marrow transplant, Whisenton was SCD-free and now only carries the trait.

Whisenton calls the date of her transplant her birthday.

 
Patient advocate
 

Whisenton has made it her life’s work to help those living with SCD. She’s the manager of sickle cell disease community engagement for the ASH Research Collaborative (ASH RC) Sickle Cell Disease Clinical Trials Net-work (CTN), established by the American Society of Hematology, the world’s largest professional society concerned with the causes and treatments of blood disorders.

Whisenton is carrying out the mission of the ASH RC CTN to improve the lives of individuals with SCD by expediting the development of new therapies through innovative clinical trial research. Whisenton ensures that the voice of the patient is heard at all stages of these clinical trials.

“SCD warriors, don’t lose hope. There are many treatments in the pipeline to help those living with this disease have a better quality of life. Our hope is that advances in research will bring more effective treatments to individuals living with SCD.” 

To search for medical conditions in a specific location visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.