Life after Cancer Clinical Trials: Study Highlights Needs of Withdrawn Patients

A new study explored how patients who exit cancer clinical trials feel about the decision to withdraw from and their post-trial transition. This study was published in JAMA Network Open.

Patient Needs after Cancer Clinical Trials

“Cancer clinical trials (CCTs) provide patients an opportunity to receive experimental drugs, tests, and/or procedures that can lead to remission. For some, a CCT may seem like their only option. Little is known about experiences of patient-participants who withdraw or are withdrawn from CCTs,” the authors wrote.

The research team from the University of Pennsylvania School of Nursing sought to evaluate participants’ experiences during the CCT withdrawal process. Through interviews with patients, the investigators noticed three major trends in patient experiences:

• Patients expressed intense symptoms, emotions, and awareness of their mortality and limited treatment options.
• Patients who felt their immediate post-trial needs were not thoroughly discussed also expressed confusion on potential next steps.
• Good communication throughout the CCT, including discussion of post-trial needs, helps assuage patient fears and disappointment.

“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,” wrote the study authors, led by Connie M. Ulrich, PhD, RN, FAAN, Professor at Penn Nursing.

Patient-participants were asked about their experiences upon withdrawal from cancer clinical trials. Ongoing research is needed to inform responsible transitions from clinical trials and ensure ethical treatment of patient-participants. @cm_ulrich https://t.co/IzhGrTOQTQ

— JAMA Network Open (@JAMANetworkOpen) August 10, 2021

Study Population and Methods

Twenty patients were interviewed for this qualitative, descriptive study. The interviews were semi-structured, with open-ended and probing questions. Transcriptions of the interviews were analyzed with a qualitative software program, which categorized the data into several broad themes.

The investigators used criterion-based sampling to identify a subset of a population of former cancer clinical trial participants who agreed to an interview at the time of exit. Between September 2015 and June 2019, the team contacted the patients via telephone consecutively until 20 interviews were completed.

Mean respondent age was 64.42 years, and 12 were men. Eighteen of 20 participants were white and 11 (55.0%) were college-educated.

Thirteen respondents withdrew from the trial due to disease progression, and five withdrew due to adverse effects. One patient cited acute illness, and another was “uncertain” about the reason for exit.

Communication is Key

The qualitative software program determined five themes of interest: post-trial prognostic awareness, goals of care discussions, emotional coping, burden of adverse effects, and professional trust and support. Other subthemes included regrets/hindsight, urgency to start next treatment, and weighing treatment benefits/burdens.

“Transcripts documented patient-participants’ unique cancer journeys, disappointment regarding a failed trial, and examination of personal values after withdrawal,” the authors wrote.

Communication between physicians and patients enrolled in CCTs was critical to patient experiences, especially regarding plans for after withdrawing from the trial. The researchers found that “limited discussions about patient-participants’ immediate post-trial care needs left many feeling that there was no clear path forward.”

In summary, the authors wrote, “CCT participation involves risks that may prove to outweigh benefits. Exiting a CCT represents a type of risk for participants, especially those withdrawn because of disease progression, lack of effect, toxic effects, or symptom burden. They must navigate next steps, including end-of-life care. CCT team members should do all they can to help patients at exit from CCTs, and this requires more dialogue and research from all stakeholders to identify best practices.”

We thank all research participants for their contributions to advancing science but as our study reports, post trial care needs are not well understood. @JAMANetworkOpen @kknafl @PennNursing @PennNCTH https://t.co/M4xBRBhhAD

— Connie M. Ulrich (@cm_ulrich) August 10, 2021