Many Patients With Cancer Left Without A ‘Clear Path Forward’ After Withdrawing From Clinical Trials

An expert from the University of Pennsylvania explains that better communication is needed between physicians and patients with cancer during clinical trials so that patients are better prepared for life after the clinical trial is over.

Recent evidence suggests that there is little discussion between care providers and patients with cancer who are receiving treatment as part of a clinical trial about what the patients’ immediate needs will be after the trial has ended.

The data — which were published in the journal JAMA Open Network — highlight that the lack of communication between provider and patient may increase the patient’s fear and feeling that their life span is short and treatment options are limited.

To ensure that patients with cancer don’t experience those intense symptoms and emotions when exiting a clinical trial, lead study author Connie Ulrich stressed that gathering more information on what patients and their families need post-trial is crucial.

“I think it is so important to hear from cancer patients and their families on their post-trial care needs, so that we can begin to develop these evidence-based guidelines that improve the overall quality of cancer care for all cancer research participants and their families,” Ulrich, who is a professor of bioethics and nursing at the University of Pennsylvania School of Nursing, said in an interview with CURE®.

Clinical trials offer patients with cancer an opportunity to receive experimental drugs, tests or procedures that may possibly lead to remission. However, little is known about those patients who either voluntarily or involuntarily withdraw from the trial. In fact, Ulrich noted that little attention is paid to the backend of a clinical trial when patients withdraw.

To assess if there were common themes among patients who withdrew from cancer clinical trials, Ulrich and colleagues interviewed 20 patient-participants (mean age, 64.42 years; 63.2% men).

Out of the respondents, 13 said their withdrawal was due to disease progression and five said it was due to side effects. Other reasons as to why patients withdrew included being uncertain why they withdraw, and the duration of their disease was short.

The data demonstrated that there were five common themes that lead patients to withdrawal from the cancer trials. Those reasons included posttrial prognostic awareness, goals of care discussion, emotional coping, side effect burden, and professional trust and support. Subthemes included regrets, wanting to start next treatment, and weighing the benefits and burdens of the treatment.

Ulrich noted that one of the major concerns among patients that led to trial withdraw was the burden associated with side effects. Patients often recognized that their quality of life was worsening due to the side effects, and the benefit the trial could have brought, she said, was not worth it.

Ulrich also mentioned other personal factors that could lead patients with cancer to withdraw from a trial such as travel, economic and physical burdens.

However, there are other times where a joint decision is made by the care team and the patient to withdraw from a trial if the patient is no longer responding to the treatment.

“It’s a conversation, that should occur with the patient’s family, if they prefer to have that conversation, and also the research team to help them think about (if this) if the best decision at this particular time,” she said.

Of note, the study results showed that patients often felt disappointed or that there was no “clear path forward” after withdrawal.

Ulrich recalled an instance about a woman in the study who had no plan for the next step after withdrawing from a trial.

“That was really profound for me to hear as to what do we need to do … to help patients transition to the next step,” she said.

She also suggested that patients who withdraw from a trial speak with their primary oncologist or their oncology nurse practitioner about their medical needs and how they can be supported through the transitional period. Other things that might help them transition out of the trial include palliative care and social worker guidance, according to Ulrich.

Overall, the study results, Ulrich concluded, indicate that the lack of communication between provider and patient during cancer-related clinical trials is potentially damaging to post-trial care.

“It has told me that there is a critical gap in our understanding of what patients and their families need at this time,” she said. “We need to assess what patients and family’s needs, perspectives and care strategies are important to them so that we can develop best practices.”

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