Clinical Trial Support: What We Can Learn from the Leukemia & Lymphoma Society
By: Vera Kovacevic, PhD
Interviewee: Leah Szumita, Director of the Clinical Trial Support Center at the Leukemia & Lymphoma Society
Clinical Trial Support: What We Can Learn from the Leukemia & Lymphoma Society
By: Vera Kovacevic, PhD
Interviewee: Leah Szumita, Director of the Clinical Trial Support Center at the Leukemia & Lymphoma Society
Finding a clinical trial for a new cancer treatment can be a daunting task, and searching for the most suitable trial can be even more overwhelming. Healthcare providers may not discuss the option of clinical trials at diagnosis or at every change in treatment as their disease progresses. As a result, patients may search for clinical trials by themselves, leaving them confused and demoralized. Access to trustworthy clinical trial support services can immensely help cancer patients find the most suitable trial for them.
The Leukemia & Lymphoma Society (LLS) does exactly that through their Clinical Trial Support Center (CTSC). Their CTSC has nurse navigators who work directly with patients, caregivers or healthcare providers to help find suitable clinical trials and overcome barriers to enrollment.
Xtalks spoke with Leah Szumita, Director of the CTSC at the LLS. Szumita discussed how the LLS improves awareness of and access to clinical trials. She also shared her thoughts on how patient enrollment can be improved, and how decentralization practices can help leukemia and lymphoma clinical trials.
“For one of the nurse navigators in the CTSC to help a patient enroll, it takes at least 23 interactions by the nurse on behalf of that patient,” says Szumita.
“I look at that number as 23 opportunities where a patient probably would've fallen through the cracks had they tried to navigate this very confusing and overwhelming process on their own.”
When a patient connects with the CTSC, they work with a dedicated nurse navigator throughout the duration of their relationship, which Szumita says could be a few weeks to months or years.
A CTSC nurse navigator begins their work by conducting a comprehensive assessment of the patient they are working with, which according to Szumita includes:
- A nursing assessment about past medical history, diagnosis and treatment history
- An educational assessment to evaluate a patient’s understanding of their available treatment options, including clinical trials to see what their goals of treatment are
- A psychosocial assessment to understand what support the patient may need to participate in a trial which will likely take them away from home and family for an extended period
“Once the CTSC nurse has all of these patient variables, they deep dive into our database…that includes everything from clinicaltrials.gov, but we augment, edit and update that information as we learn about certain clinical trials,” says Szumita.
Next, the CTSC nurse navigator gets back to the patient in one to two business days with the clinical trials a patient may potentially be eligible for.
“We do not give someone a 20-page printout of clinical trials because we know that's overwhelming for the patient, but also overwhelming for the provider to try to make heads or tails of,” says Szumita. “It's really a refined list of potential options.”
The CTSC nurse navigator encourages the patient or caregiver to share the list of potential clinical trials with their healthcare team for their additional medical expertise. By doing so, the CTSC emphasizes the importance of shared decision-making between a patient and their healthcare team.
“We are not just a trial matching service — we really are a comprehensive navigation service.”
- Leah Szumita, director of the CTSC at the LLS
But the work doesn’t stop then. Once the CTSC nurse navigator knows what the patient is interested in, they do continued outreach on the patient’s behalf. This outreach helps the nurse navigator and patient learn more about a trial’s eligibility, referral process, waitlist and available resources like travel assistance.
Adding to that, the nurse navigator always works in the patient’s best interest to help them find the most appropriate treatment. This may involve helping a patient to confidently move forward with the standard of care treatment or helping them get a treatment through off-label or compassionate use. The CTSC team could also help patients transition to palliative care.
Szumita says the services provided by her team are free and last throughout the entire clinical trial process. Importantly, they don’t have any incentive to enroll someone into a clinical trial, eliminating a potential conflict of interest.
How Can Patient Enrollment Be Improved?
Szumita explains that the main way to boost participation in oncology clinical trials is to increase awareness and access to these trials.
“There's lots of awareness challenges, and certainly historical events related to clinical trials, as well as myths about clinical trials contribute to that,” says Szumita. “So, we want to destigmatize clinical trials and have them discussed more often.”
Finding a clinical trial for a new cancer treatment can be a daunting task, and searching for the most suitable trial can be even more overwhelming — but it doesn't have to be that way.
Healthcare providers may not discuss the option of clinical trials at diagnosis or at every change in treatment as their disease progresses. As a result, patients may search for clinical trials by themselves, leaving them confused and demoralized. Access to trustworthy clinical trial support services can immensely help cancer patients find the most suitable trial for them.
The Leukemia & Lymphoma Society (LLS) does exactly that through their Clinical Trial Support Center (CTSC). Their CTSC has nurse navigators who work directly with patients, caregivers or healthcare providers to help find suitable clinical trials and overcome barriers to enrollment.
Xtalks spoke with Leah Szumita, Director of the CTSC at the LLS. Szumita discussed how the LLS improves awareness of and access to clinical trials. She also shared her thoughts on how patient enrollment can be improved, and how decentralization practices can help leukemia and lymphoma clinical trials.
"For one of the nurse navigators in the CTSC to help a patient enroll, it takes at least 23 interactions by the nurse on behalf of that patient,” says Szumita.
“I look at that number as 23 opportunities where a patient probably would've fallen through the cracks had they tried to navigate this very confusing and overwhelming process on their own.”
When a patient connects with the CTSC, they work with a dedicated nurse navigator throughout the duration of their relationship, which Szumita says could be a few weeks to months or years.
“We are not just a trial matching service — we really are a comprehensive navigation service.”
— Leah Szumita, Director of the CTSC at the LLS
A CTSC nurse navigator begins their work by conducting a comprehensive assessment of the patient they are working with, which according to Szumita includes:
- A nursing assessment about past medical history, diagnosis and treatment history
- An educational assessment to evaluate a patient’s understanding of their available treatment options, including clinical trials to see what their goals of treatment are
- A psychosocial assessment to understand what support the patient may need to participate in a trial which will likely take them away from home and family for an extended period
“Once the CTSC nurse has all of these patient variables, they deep dive into our database…that includes everything from clinicaltrials.gov, but we augment, edit and update that information as we learn about certain clinical trials,” says Szumita.
Next, the CTSC nurse navigator gets back to the patient in one to two business days with the clinical trials a patient may be eligible for.
“We do not give someone a 20-page printout of clinical trials because we know that's overwhelming for the patient, but also overwhelming for the provider to try to make heads or tails of,” says Szumita. “It's really a refined list of potential options.”
The CTSC nurse navigator encourages the patient or caregiver to share the list of potential clinical trials with their healthcare team for their additional medical expertise. By doing so, the CTSC emphasizes the importance of shared decision-making between a patient and their healthcare team.
But the work doesn’t stop then. Once the CTSC nurse navigator knows what the patient is interested in, they do continued outreach on the patient’s behalf. This outreach helps the nurse navigator and patient learn more about a trial’s eligibility, referral process, waitlist and available resources like travel assistance.
Adding to that, the nurse navigator always works in the patient’s best interest to help them find the most appropriate treatment. This may involve helping a patient to confidently move forward with the standard of care treatment or helping them get a treatment through off-label or compassionate use. The CTSC team could also help patients transition to palliative care.
Szumita says the services provided by her team are free and last throughout the entire clinical trial process. Importantly, they don’t have any incentive to enroll someone into a clinical trial, eliminating a potential conflict of interest.
How Can Patient Enrollment Be Improved?
Szumita explains that the main way to boost participation in oncology clinical trials is to increase awareness and access to these trials.
“There's lots of awareness challenges, and certainly historical events related to clinical trials, as well as myths about clinical trials contribute to that,” says Szumita. “So, we want to destigmatize clinical trials and have them discussed more often.”
One way to do this is to help educate community care providers to be able to talk about clinical trials with their patients. Healthcare providers should also talk more about clinical trials with their patients.
Szumita shares that people need to be more aware that there are clinical trials for every stage of disease; for those who are newly diagnosed, relapsed or refractory, but also for people on maintenance therapy, remission or into survivorship.
In addition, the word needs to get out to underrepresented populations to help them know that clinical trials are an option.
Szumita also says that the LLS advocates for addressing the financial burdens related to patients achieving the best health care and participating in clinical trials.
Adopting DCT Approaches in Leukemia and Lymphoma Trials
Most oncology clinical trials are conducted at large academic cancer centers, and most people don’t live near them. For a patient to travel to a large cancer center, they need a lot of financial support as well as time away from work and other obligations, like family responsibilities.
Szumita says that decentralized clinical trial (DCT) methods can help bring better care closer to patients.
“Perhaps patients could get their blood work or some of their scans done at a local community hospital,” suggests Szumita. “Or maybe they could have some of their consults done virtually or sign a consent form virtually.”
Nonetheless, Szumita says that to increase the adoption of DCT methods, there are a few implementation challenges that need to be addressed. For instance: more financial investments are needed to bring clinical trials to the community setting; policies and regulations that support a decentralized approach need to be in place; and the licensure for providers offering virtual consults should be there.
“The LLS has an amazing office of public policy that is continuously working diligently on behalf of patients to help support bringing clinical trials closer to patients,” says Szumita. “So, it's certainly an organizational priority.”
If there is a prospect to bring a trial to the patient, it is certainly a worthwhile endeavor — and something that ought to continue to be top of mind for industry stakeholders in oncology trials.
ABOUT Leah Szumita
Leah Szumita is the director of the Clinical Trial Support Center at the Leukemia & Lymphoma Society (LLS), where she leads a team of nurse navigators with expertise in pediatric and adult hematology/oncology.
