Looking Closely at Cancer Clinical Trials and the Patient Experience

By Allison Proffitt

August 25, 2021 | In a study published this month in JAMA Network Open, a team from the University of Pennsylvania School of Nursing worked with 20 patients with cancer that withdrew or were withdrawn from a cancer clinical trial to help clarify the post-trial needs of cancer patients participating in clinical trials and define what constitutes responsible transitions when patients exit trials.

While clinical trials are essential to cancer research and can provide patients an opportunity to receive experimental drugs, tests, and/or procedures that can lead to remissions, the study authors (DOI:10.1001/jamanetworkopen.2021.20052) argue that little is known about the experiences of patient participants who withdraw from trials.

“Understanding the post-trial needs of patients with cancer and their families represents a measure of ethical respect of the many contributions that patients with cancer make to advancing our scientific knowledge and finding treatments that save lives,” said Connie M. Ulrich, PhD, RN, FAAN, Lillian S. Brunner Chair in Medical and Surgical Nursing, Professor of Nursing, Professor of Medical Ethics and Health Policy, and lead investigator.

Between September 2015 and June 2019, the research team interviewed twenty patients with cancer. They chose the cohort from adult patients with cancer who were former clinical trial participants and who agreed on exit from those trials to a later interview about withdrawal experiences.

Thirteen respondents reported trial withdrawal as a result of disease progression; eleven patients had stage IV cancer at enrollment. Five withdrew because of adverse effects. The rest reported acute illness or uncertainty about why they withdrew.

“For many (14 of 20 participants [70.0%]), the ultimate fear was death, and they bargained for more time,” the authors noted. “For them, CCTs represented hope or the key to survival.” Having to withdraw from a trial, then, can be a major blow.


Ticking Clock

The authors report that patient-participants withdrawing from a clinical trial “described feeling intense symptoms and emotions and awareness that their life span was short and options seemed to be limited,” they write in the paper. They recommend communication throughout a cancer clinical trial that is attuned to post-trial needs and emotions, acknowledging that patients are likely to be scared and disappointed when withdrawing from a trial. They will need help navigating next steps.  

“For those with a good understanding of advanced-stage cancer, there was a sense of urgency to start the next treatment after CCT withdrawal, which stemmed from the knowledge that their cancer would continue to grow without treatment,” the authors write. “Some participants enrolled in the next trial at the same appointment during which they learned they had been withdrawn from the original CCT. Many participants (15 of 20 participants [75.0%]) expressed an unwavering belief that CCTs are the source of breakthrough treatments and wanted to enroll in another trial.”

The authors advise further research focusing on components of responsible and ethical cancer trial transitions, including types and timing of discussions and who should begin these discussions with patient-participants and their families.

But they did some immediate recommendations. “Delivery of palliative care concurrently with disease-directed therapies should become a standard at cancer institutions, as palliative care consultation has been shown to improve quality of life and emotional states in patients with advanced cancer,” they wrote. Some patients would avoid palliative care as they sought a new trial.

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