The Case of the Clinical Trials Consultation

December 21, 2021 by Deborah Christensen MSN, APRN, AOCNS®

Don, age 72, was diagnosed with borderline resectable pancreatic adenocarcinoma more than a year ago. Genetic testing indicated a BRCA2 variant. He completed 12 cycles of FOLFIRINOX followed by a pancreaticoduodenectomy (Whipple procedure). He had no evidence of disease for six months until a liver lesion seen on surveillance imaging tested positive for metastatic pancreatic cancer. His medical oncologist suggests a clinical trial targeting the BRCA2 variant.

As the clinical trials nurse, you meet with Don and his son to discuss a study being offered at your institution. Don’s son explains that he would like to move his father to another state for additional family support and asks you how he can find out about other clinical trials in that area.

What Would You Do?

Barriers to clinical trial participation can be structural, clinical, or attitudinal. For example, physicians may not recommend clinical trials that require the patient to travel, which restricts their choices to those being conducted close to home. Clinical trial inclusion and exclusion criteria can limit trial recruitment and disappoint patients who do not qualify for a study. Patients may have concerns about the way a study is structured (e.g., the possibility of being randomized to a control arm instead of the intervention that includes the study drug). Unfortunately, patients may find they are excluded from a study because of previous treatments or underlying conditions.

Despite the barriers, approximately 55% of patients who are offered a clinical trial decide to participate. Oncology nurses in both traditional and clinical trials roles can help guide and support patients and their families while searching for and participating in those studies.

Navigating the many oncology clinical trials available can be challenging. Research studies may be designed to look at cancer prevention, diagnosis, treatment, or managing treatment-related side effects. Databases like ClinicalTrials.gov allow users to search National Cancer Institute (NCI)-sponsored studies by disease type, trial location, and recruitment status. Pharmaceutical companies also sponsor studies and can reimburse cancer centers for patient enrollment at rates higher than government-sponsored studies.

You refer Don and his son to the information for patients and families located at ClinicalTrials.gov to learn how to search for and understand the NCI-sponsored clinical trials.


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