A study of patients who were withdrawn from cancer clinical trials found themes of intense emotions. These findings were published in JAMA Network Open.

When patients are withdrawn from clinical trials, contact is often lost, and their reactions are not included in trial data. A qualitative, descriptive study was conducted to better understand what patients experience after withdrawal from a cancer clinical trial.

Twenty patients with cancer who had withdrawn from a clinical trial at a National Cancer Institute-designated comprehensive cancer center affiliated with the University of Pennsylvania were contacted by telephone between 2015 and 2019. A semistructured interview was conducted and participants were asked about their experience and feelings about the withdrawal process.

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Patients were mean age 64.42±8.49 years, 63.2% were men, 94.7% were White, 64.7% had stage IV cancer at trial enrollment, and the average time between trial consent to withdrawal was 143±95.3 days. They reported their withdrawal occurred due to disease progression (13), adverse effects (5), and acute illness (1), with one who was uncertain.

Participant responses fit 5 major themes: post-trial prognostic awareness, goals-of-care discussions, emotional coping, burden of adverse effects, and professional trust and support.

Patients expressed a wide range of negative emotions including fear, sadness, anxiety, or shock and 90% indicated they were relying on some form of support from professionals, family, or friends.

Few patients said they were withdrawn from the clinical trial, but instead expressed that they did not fully understand why they had been withdrawn using words such as “taken off,” “removed,” or “stopped.” Many expressed urgency to start the next treatment fearing that their cancer will progress without active treatment.

These findings may not be generalizable as all participants were recruited from a single center. However, these data indicate that many patients who were withdrawn from cancer clinical trials experienced adverse emotional effects and likely required additional support.

Reference Ulrich CM, Knafl K, Foxwell AM, et al. Experiences of patients after withdrawal from cancer clinical trials. JAMA Netw Open. 2021;4(8):e2120052. doi:10.1001/jamanetworkopen.2021.20052

This article originally appeared on Oncology Nurse Advisor