HemOnc Today's PharmAnalysis

HemOnc Today's PharmAnalysis

Disclosures: Szumita reports no relevant financial disclosures.
August 17, 2021
4 min read

Navigation service assists patients in search for cancer clinical trials

Disclosures: Szumita reports no relevant financial disclosures.
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A free nurse navigation service helped overcome barriers to clinical trial enrollment for patients with blood cancer, according to study results published in JCO Oncology Practice.

“We have observed evidence of success with our program model,” Leah Szumita, MS, RN, LCSW, director of the Clinical Trial Support Center at The Leukemia & Lymphoma Society (LLS), told Healio.

Infographic showing enrollment in cancer trials with or without nurse navigator assistance
Data derived from Sae-Hau M, et al. JCO Oncol Pract. 2021;doi:10.1200/OP.20.01068.

The Clinical Trial Support Center employs oncology nurses with extensive training who assist patients one-on-one in the search for clinical trials and help overcome barriers to trial enrollment. During the study period, the clinical trial enrollment rate was 22.5% among U.S. patients served with a known enrollment outcome after undergoing a trial search.

Leah Szumita, MS, RN, LCSW
Leah Szumita

“Considering the national average of clinical trial enrollment for patients with cancer is about 5% to 8%, removing access barriers is crucial to increase options for patients and advance cancer treatment research,” Szumita said. “Our goal is not necessarily to have every patient enroll in a clinical trial, but to increase awareness of opportunities to receive treatment within a clinical trial, facilitate informed and shared decision-making with the oncologist during the treatment decision-making process, and minimize barriers to enrollment if the patient and his or her health care team decide that a clinical trial is right for him or her.”

Szumita spoke with Healio about the navigation service, how it can help increase trial participation and the potential to apply the model across cancer diagnoses.

Healio: What does the navigation service entail?

Szumita: The Clinical Trial Support Center includes a team of nine nurse navigators with expertise in hematologic malignancies. We work with patients and their caregivers to help identify potential clinical trials and overcome barriers to enrollment. There is complete continuity of care throughout the relationship; a patient works with the same dedicated nurse navigator over a period of many months, if not years. We spend a lot of time at the beginning conducting not only a comprehensive assessment of past medical history, including diagnosis and treatment, but also a psychosocial assessment to really understand the patient’s values, financial status, family support and ability to travel or be away from home or employment.

We dispel common myths about clinical trials and provide education. We give people the information and resources they need to go back to their oncologist or get a second opinion — all while emphasizing shared decision-making and helping them make the treatment decision that is in their best interest. This may be a clinical trial, it may be standard of care, it may be getting treatment through off-label or compassionate use, or it may be transitioning to palliative care. The nurse navigator is there to help the patient through whatever their journey may be.

Healio: What barriers to trial enrollment does the service help patients overcome?

Szumita: There is lack of awareness that clinical trials are a potential treatment option for every stage of disease. There are financial barriers for those who lack health insurance or have a policy that does not cover the cost of clinical trials or out-of-network care. The financial demands of being away from home or making frequent trips to and from the cancer center are another barrier. Trial inclusion and exclusion criteria alone can preclude someone from participation.

The Clinical Trial Support Center works closely with our Information Resource Center, staffed by a team of amazing highly trained oncology social workers, nurses and health educators who help patients access educational and financial resources, etc.

LLS has many resources for patients and caregivers. The Clinical Trial Support Center works closely with our Information Resource Center, operated by a team of amazing health care providers who help patients identify educational and financial resources, etc. LLS has and is knowledgeable about many resources for patients, their families and health care providers.

Healio: What results have been observed so far?

Szumita: Helping someone enroll onto a clinical trial is time-intensive. Our data show it takes 25 interactions by a nurse navigator to help a patient enroll onto a clinical trial. Those interactions may include emails or phone calls to trial sites or principal investigators to inquire about eligibility requirements, waitlists and referral processes, the process for second opinions, or to learn if a new site is opening and what cohort is open in the trial. This speaks to the amount of work it can take for patients and their providers to identify and enroll in trials.

Healio: Do you have plans to expand this model or do something different to increase trial enrollment even further?

Szumita: We are working hard to help improve awareness of and access to clinical trials, particularly among underserved populations. Also, it is worth noting the type of expertise within our group: We have two pediatric nurse practitioners, one adult nurse practitioner, three clinical trial research nurses and other advanced practice nurses. We have a great depth of experience and expertise. Our group is continuing to grow, and we will soon add a bilingual nurse navigator. This model seems replicable for diagnoses other than hematologic malignancies. The challenges to clinical trial enrollment are not specific to patients with blood cancer. They exist across all cancer diagnoses. Therefore, expansion of a model like this — one-to-one assistance to help patients overcome many barriers to enrollment — would be worthwhile.

Healio: What potential impact could an intervention like this have on trial enrollment and outcomes if it is more widely adopted?

Szumita: Clinical trials are a key step in advancing cancer treatment. Unfortunately, approximately 20% of cancer clinical trials in our country close because they do not have enough patients to enroll. The more we raise awareness of and dispel myths about clinical trials, the more people will enroll. This not only helps increase potential treatment options for the patient, but also helps advance science toward more effective and less harmful cancer treatments.

Healio: What would you like patients and caregivers to know?

Szumita: Clinical trials may be available for every stage of disease, not just for patients who have failed previous lines of treatment. Clinical trials should be discussed as a potential treatment option early, and at every treatment plan discussion with the health care team.

Healio: Is there anything else you would like to mention?

Szumita: Providers can refer patients to us, as well. Patients or health care providers who wish to learn more may call The Leukemia & Lymphoma Society Information Resource Center at (800) 955-4572 or go to lls.org to complete a referral form.

For more information:

Leah Szumita, MS, RN, LCSW, can be reached at leah.szumita@lls.org.