If you join a clinical trial, you may want to share the news. But words are powerful, and can impact the study. This interactive infographic shares information and videos about clinical research and how to best communicate about it. Access it here.
Educational Curriculum Made Possible by Collaboration of Experts from Northeastern University
The Global Resilience Institute at Northeastern University released a “COVID-19: Staying Safe, Resilient & Protected” website to assist the public and provide comprehensive information on vaccines, how to be safe and resilient, and enterprise restart and recovery tactics.
You can access the site here.
Content is delivered in English and Spanish.
Juana Espino, her husband and two children were all looking forward to the birth of her third child. Two weeks before her delivery date, Juana started spotting blood. Juana immediately made an appointment with her obstetrician. During the exam, the physician located a mass near her cervix and recommended a biopsy, after the baby’s birth. Juana’s c-section went well and her new daughter was healthy.
But Juana was not.
The results of the biopsy indicated that she had Stage 4 cervical cancer.
“From there, it was just a rollercoaster, at first,” recalled Juana. “I didn’t have health insurance. You always have a pap smear at the beginning of your pregnancy, and mine was normal. The cancer had really grown while I was pregnant, and the doctor was worried about it metastasizing.”
The incidence of cervical cancer complicating pregnancy is low; only about 1% – 3% of woman diagnosed with cervical cancer are pregnant or postpartum when they are diagnosed. (1)
After discussing several options of treatment, Juana’s obstetrician advised that she meet with Dr. Joseph A. Lucci, a board-certified gynecologic oncologist at The University of Texas Health Science Center at Houston (UT Health). Dr. Lucci was also the Principal Investigator of a clinical trial treating Stage 4 cervical cancer. Juana met with Dr. Lucci and learned more about the course of treatment that the trial would include: a hysterectomy, followed by 6 weeks of chemotherapy and radiation.
“The good thing is, I have a big family,” said Juana. “I talked about it with my husband and my 6 sisters went with me to talk with Dr. Lucci about the clinical trial. I am grateful that I had a big support system. I was truly blessed.”
Since Juana was the mother of a newborn, it was decided to delay chemotherapy and radiation for two months. This lead to another difficult decision.
“Because I was having radiation treatment, we decided that my mother would take care of our baby, to be on the safe side,” Juana recounted. (Patients receiving certain types of radiation treatment are advised to limit or avoid contact with children under the age of 18 and pregnant women. (2) “It was hard, to be honest, but I knew my mother would take good care of her. I did get to see the baby, of course, and when I did, I was really careful. I would dress in layers (because of the radiation) and hold her on a pillow, not directly.”
Juana’s sisters were encouraging when the effects of the radiation treatment became particularly severe during the last part of treatment. “I didn’t feel as sick during chemo as I did during the radiation,” Juana explained. “The radiation was really painful and my sisters kept telling me that I could do it.”
Aileen, Juana’s niece, was also instrumental in supporting her during treatment. “She postponed going to college, to be with me on this journey,” said Juana.
Juana was impressed with the care she received during the clinical trial. “I could call Carole Robazetti (the coordinator) in the middle of the night, and she’d be there. Dr. Lucci was also available at any time to discuss how I was feeling and what was happening,” said Juana. But Juana didn’t discuss one major impact that she experienced, until three years after the trial had concluded.
While participating on a CISCRP Patient Advisory Board, Juana listened to panelists describing the physical and emotional impacts of severe atrophic vaginitis, symptoms that she was experiencing, but never discussed with Dr. Lucci or Carole. (CISCRP Patient Advisory Boards solicit feedback and gather valuable insights directly from patients and their support network on a variety of critical clinical study related areas. Learn more here.
“I was afraid to speak up and after I heard the others share their stories, I decided to talk with Carole. She asked me why I hadn’t said anything before, and I just hadn’t felt comfortable.” Juana was prescribed medication that has improved the condition significantly.
The treatments Juana received in the clinical trial eradicated the cervical cancer. Juana and Carole became friends.
“I really wanted to give back somehow, and Carole told me about WOW, the Women Well Program,” said Juana. WOW was founded in 2018, under the umbrella of the Latattore Foundation and the University of Texas. WOW provides pap smears and mammograms at no cost to low-income/uninsured women through monthly community health fairs. Learn more about WOW at https://latattore.com/wow/.
“Members of the Hispanic community don’t always have health insurance, so WOW is helping to save peoples’ lives. I started as a volunteer and now I’m on staff,” said Juana.
Juana says she would participate in a clinical trial again, and that she would be more open to discussing related impacts. “We need to speak and let people know what’s happening,” Juana said.
When asked if she has any words of advice to individuals considering clinical trial participation, Juana advised the following.
“When you’re deciding about a clinical trial, read everything. Read every detail. Those little details will help you decide if you want to be part of it. And get a second opinion before you make your final decision.”
Race and Gender Play Role in Patient Views About Clinical Research During COVID-19 Pandemic
CISCRP partnered with SubjectWell, a patient recruitment firm, polling 553 patients in the United States to review how race and gender impact clinical trial participation, during the COVID-19 pandemic.
Respondents report concerns about being exposed to COVID-19 if enrolled in a clinical trial. By gender, the survey found that men are less hesitant to participate in non-COVID-19 than women. Women place higher values on precautions such as being able to communicate with a study physician remotely. African American patients are more concerned with precautionary measures like limiting the number of site visits and having the ability to send lab samples from home compared to Caucasian patients.
For information about collaborating with CISCRP on research initiatives, contact Annick de Bruin, Senior Director, Research Services, at 617-725-2750, extension 400 or at firstname.lastname@example.org.
Jackie Zimmerman is an accomplished entrepreneur, marketing professional, former roller derby league president, and non-profit founder with a “can-do” energy that is immediately evident when you speak with her. She is also a patient advocate for individuals with multiple sclerosis, receiving the diagnosis during college, at the age of 21. In the face of this world-rocking news, Jackie powerfully pivoted, sharing her story with others and later, becoming a patient 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. Her response? It was the mid-2000s, so Jackie turned to one of the newest forms of digital communication, 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 MS which first presented during a flare. At that time, the standard of care was injectable medications.
“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 factor complicating the treatment of MS is that in terms of symptoms, prognosis and reactions to medications, no two cases are alike.
Jackie first participated in a clinical trial in 2008 for a MS medication, but being in treatment concurrently for Inflammatory Bowel Disease (IBD) was skewing the results and after a short time, she was asked to withdraw from the clinical study. 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 IBD, and her role as a patient advocate scaled, which led to public speaking engagements as well as work with healthcare and pharmaceutical companies looking to connect with patients.
Two factors 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.”
(COVID-19 has accelerated the adoption of 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 report here).
When asked about other determinants 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.”
The conversation then turned to what advice Jackie would offer readers considering 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.”
Lupus is an autoimmune disease that causes your body’s immune system to attack your tissues and organs. Difficult to diagnose, Lupus can remain dormant in an individual’s body, only to be “woken up” by an illness or major surgery. This was the case for Leah Crocker. In 2000, Leah had just undergone carpal tunnel surgery on both hands but wasn’t healing properly. At this time, her orthopedic surgeon suggested she consult a rheumatologist. Upon seeing a rheumatologist her blood work came back positive for Lupus.
A disease with no cure, Lupus is managed through treatments that help patients control their symptoms. Soon after her diagnosis Leah began experiencing numbness in her fingers. This issue was identified as Raynaud’s phenomenon, a common symptom of Lupus. Raynaud’s is a condition that results in the discoloration of the fingers and toes in response to cold temperature or stress. During this time, Leah was prescribed an anti-malaria drug to help. However, her condition would soon grow worse when she discovered that gangrene had set into two of her fingers. At the time she had a choice between amputation or chemotherapy. Leah chose to undergo chemotherapy, which she continued for several years.
Despite undergoing treatment for Raynaud’s, because of the severity of her condition her rheumatologist strongly recommended that she relocate to a warmer climate to reduce the chances of her condition worsening. For Lupus patients in similar situations Leah advises, “Know your limitations and live within them.” So, in 2007 she made the move from her home state of New Jersey to start a new life in Georgia. After relocating to Georgia Leah connected with a new rheumatologist Sam Lim at Emory University School of Medicine.
This is when her clinical trial journey began. Leah credits Dr. Lim for encouraging her to get involved in clinical trials. The first study she joined was The Georgians Organized Against Lupus study, led by Dr. Lim at Emory University in 2013. The goal of this study is to better understand the burdens of Lupus. Leah has been involved in this study for the past several years, participating in in-person visits once a year and completing an online questionnaire twice a year. Leah also participated in another trial for Raynaud’s in 2015. This trial was studying the effects of Botox on individuals with Raynaud’s. As part of the trial she was asked to hold her hands under cold water and receive Botox injections. Despite the challenging experience, Leah is happy to have participated in this trial.
An experienced clinical trial volunteer, Leah’s advice to those thinking of participating is, “Just do it.” At the time of her diagnosis there were fewer medications available for individuals like Leah. Today, thanks to clinical trial volunteers, there is newfound hope for the Lupus community. To find trials for Lupus in your area visit CISCRP’s Search Clinical Trials page. For more information about Lupus, treatments, clinical trials, community forum and other educational information, please visit www.lupusresearch.org
On January 6, 2018, at the age of 51, Sandy Morris was diagnosed with Amyotrophic Lateral Sclerosis, also known as ALS. ALS is a progressive nervous system disease that affects the nerve cells in your brain and spinal cord. The disease causes individuals to lose control of the muscles needed to move, speak, eat and breathe. According to the ALS Association, every 90 minutes someone is diagnosed with ALS and someone passes as a result of the disease. There is currently no cure for this debilitating disease.
Sandy spoke candidly about the effects of ALS, “No one wants their body to trap them.” A mother of 3, she was determined not to give up hope. Following the advice of her best friend, she got involved in a clinical trial at the California Pacific Medical Center. As part of the trial, she had to undergo bone marrow extraction in order to retrieve stem cells which was followed by a series of infusions and lumbar punctures. Although the clinical trial involved invasive procedures, she describes her experience as an overall positive one. Regarding her participation Sandy stressed, “I would rather die trying. I don’t want to just accept my fate.”
ALS affects everyone differently. Sandy explained, “How we progress is totally unique. I have some friends who can’t talk but can walk, and others who can walk but can’t talk.” For individuals considering participating in a trial, she stressed the importance of being well informed by researching the treatment being tested. Sandy shared her willingness to participate in future clinical trials and encourages others to educate themselves until ALS treatments and cures are found. She encourages others to get involved noting, “That’s the only way we’re going to move forward.”
There are currently four medications available to treat ALS. But more research remains to be done to find a cure. Despite ALS being a fatal disease, Sandy remains hopeful, “We just need a happy ending and we don’t have one yet.” Her advice for other ALS patients and their loved ones is to remain as positive as possible while learning to live with their disease, something she acknowledges is not an easy thing to do.
Sandy discussed ways she wants to continue to make a difference including attending FDA meetings to share her experience and influence more efficient, humane clinical trial design. She also stressed the importance of pharmaceutical companies and patients working together to create clinical trials. Her goal is to create hope for the future. Sandy stressed, “I want to make sure that the next 51-year-old mother of three doesn’t have to hear she has ALS period. I want a comma, nothing finalized.”
At the beginning of the pandemic in mid-March, Katie Klatt, a nurse on a COVID-19 infection control team, received the news that she had contracted the virus herself. “I wasn’t too surprised,” Katie said. “I kind of knew, but the actual confirmation was a little bit scary. It was early on so no one in the US really understood how bad it was.” A healthcare professional, Katie’s background includes working as a PICU nurse and she had just moved to Boston to pursue her Master in Public Health at the Harvard Chan School. Now fully recovered, Katie is a patient participant in a COVID-19 antibody clinical study. This is her story.
Katie contacted her primary care physician when she started having symptoms. “I was treated in two different ways. The first week I was seen via telehealth, and that was literally the same week that so many medical professionals and patients were turning to that option. My doctor was retiring, so I didn’t really have anyone following me. The onus was on me to check in and report my symptoms.” At the end of the first week, Katie was advised to be seen in person, at an urgent care clinic. However, being symptomatic, she could only be seen at the urgent care if she was a previous patient. Being new to the area, this was not the case. Her only other option was to go to an emergency room.
“At first, I didn’t think I was sick enough to go to the ER. I didn’t want to take an Uber and infect anyone else and I was too tired to ride my bike. So I waited until the Tylenol kicked in and walked 40 minutes to the hospital. At the emergency room, they were really well set up. When I walked in, people started to call ‘Rule out!’ which means a COVID-19 patient is entering the area, so people started to move away from me as I passed by. After I was seen, Security escorted me out the back door to protect other patients and staff,” Katie said.
The hospital pharmacy was closed, so Katie was handed a paper prescription to have filled elsewhere. Even though she was wearing a N-95 mask her mother had sent to her a few weeks before she got sick, Katie realized that she should not enter a store. She was also concerned about handing the paper prescription to a pharmacy technician. Katie called a friend who met her at the pharmacy with a clear plastic sandwich bag. She dropped the prescription in it and her friend brought it inside and had it filled.
In addition to having COVID-19, Katie also had a sinus infection. When she was diagnosed, Katie knew what to do. “Stay at home, isolate, hydrate and rest,” Katie stated plainly. “As a healthcare provider, we tend to minimize our own complaints because we’ve seen so much worse, so my view of it was skewed. Having a 103 degree temperature for 10 days, it was almost like I got used to having the chills and feeling exhausted constantly.”
Katie socially isolated from her roommates, staying in her room and only entering the kitchen when they were not present. “I had the presence of mind, despite the high fever, to clean everything I touched – that’s from my nursing background. I’m happy to say my roommates didn’t get the virus.” Family and friends sent care packages and checked in with phone calls and texts which helped buoy Katie’s spirits.
A few days after starting medication, Katie began to rapidly recover. She attributes this, in part, to being a lifelong athlete, playing in Australian and Gaelic football leagues. “When I got COVID-19, I lost about 10 pounds in a week and I lost a lot of my fitness. When my taste started to come back, I was able to eat more and work towards regaining my fitness.”
Katie is using her experience with COVID-19 to assist others. “A friend of mine who is a nurse told me about a clinical study, so I registered for it. The purpose of the study is to monitor levels of COVID-19 antibodies present to see how long they last in a recovered patient’s body. It’s a two-year commitment.” On a monthly basis, Katie’s blood is drawn and analyzed. Currently, she has not been notified of recent results and she hopes to be informed soon.
In her role as a nurse on the COVID-19 infection control team at Boston Emergency Medical Services, Katie shares her story with EMTs and paramedics who have been exposed to or have contracted the virus while treating and transporting patients. “This is an isolating disease,” Katie explained. “Not having a stigma attached to it is important. It helps them when I explain what I went through when I was sick.”
When asked if she is concerned about contracting COVID-19 again, Katie said “I probably should be. I have reached the same fatigue that everyone in the world has now, around COVID-19. It’s hard to maintain that level of high alert. But I am being careful, more for others than for myself. I wear a mask everywhere, even when I am running outside. I do it because I don’t want anyone else to get it.”
Katie cautions others to be just as vigilant. “Just because we’re opening up, it’s not over. Wear a mask to protect yourself and others. Keep talking about it so that people don’t forget.”