Patients Withdrawing From Cancer Clinical Trials May Need Extra Attention and Care

By Linda Carroll

August 13, 2021

(Reuters Health) - Patients exiting clinical cancer trials may experience intense symptoms and emotions, as well as awareness of their impending mortality and the limited options open to them, a new study finds.

An analysis of the responses of 20 patients who agreed to be interviewed about their cancer clinical trial withdrawal revealed five themes: post-trial prognostic awareness; goals of care discussions; emotional coping; burden of adverse effects; and professional trust and support. Subthemes included regrets/hindsight, urgency to start a next treatment, and weighing the benefits and burdens of treatment, according to the report published in JAMA Network Open.

"Cancer patients participate in cancer clinical trials for the hope of benefit and we, as researchers, bioethicists, and others, value their participation to advance knowledge of their diseases and to develop future treatments that can mitigate the burden of cancer," said the study's lead author, Connie M. Ulrich, Lillian S. Brunner Endowed Chair in Medical/Surgical Nursing, professor of nursing and professor of medical ethics and health policy at the University of Pennsylvania School of Nursing and the Perelman School of Medicine in Philadelphia.

"At the same time, we need to help patients and their families at exit from these trials as they navigate their next steps, including end-of-life," Ulrich said in an email. "Post-trial care needs are just as important as pre-trial recruitment efforts, but there is a critical gap in understanding responsible transitioning of participants from these trials when they are withdrawn or withdraw from clinical trials as they may be disappointed by the lack of benefit they received and regretful about their participation."

Currently, "guidance is lacking on policies, best practices and communication strategies for ethically transitioning these patients from cancer clinical trials and supporting patients and their family caregivers at this difficult time in their lives," she added.

Ulrich hopes the new study will help guide care for these patients.

"Every cancer patient who participates in clinical trials deserves our respect for the contributions they are making to science," she said. "This respect must include more dialogue and research that includes discussions with the clinical research team and cancer patients and their families on their exit experiences and the quality of care provided at this key transition. Difficult discussions about next steps (advance care planning, end-of-life, support within one's community for medical treatment, or the availability of another clinical trial), should they be needed, must start early and be ongoing."

To explore the experiences of cancer patients withdrawing from clinical trials, Ulrich and her team recruited and interviewed 20 adult patients who had a cancer diagnosis in one of four categories: gastrointestinal or genitourinary cancer; hematological or lymphatic malignant disorders; lung cancer; and breast or gynecological cancer.

Among the themes that arose from the interviews was the emotion that withdrawal produced. One patient talked about the disappointment of being taken out of the trial: "A 70 percent reduction. I was elated. I was happy. I had no side effects, and I couldn't have been happier. My Doctor … was very happy. Then what happened was I had a scan and the scan came back saying that I had one or two new nodes that were somewhat active in my neck as I recall. The protocol of the trial says any new nodes, you know, you come off the trial. Well, that's where the protocol of the trial and the patient benefit collided, because I'm obviously benefiting if their own records show that I had a 70 percent reduction and I had no side effects and no nodes that I could feel. They were all so small that they were internal type things that you couldn't feel."

Another theme was a view of the trial in hindsight and, potentially, regrets. An example was a patient who in hindsight thought the trial was a mistake: "But, you know, the next six months of my…you know, I probably can't fly the way I want to and travel the way I want to and…This is kind of messing the rest of my life up…I'm frustrated and angry, to be quite honest with you - because…this is not the summer the way I thought. Okay, I'm done my treatment. I'm gonna be fine. I was feeling good. And I started taking this stupid drug and all of a sudden, you know, I've had the reaction and now the PEs, and now the next six months or whatever, it's gonna be I have to stay on blood thinners and…you know, I can't go back to karate. Like all the things that make me sane, I can't do."

The study is very interesting, said Margaret Quinn Rosenzweig, associate director of catchment area research for UPMC Hillman Cancer Center and a professor of nursing at the University of Pittsburgh School of Nursing.

"The study highlighted a population of patients who are very important but often not acknowledged – those who have agreed to be on a clinical trial and then need to be discontinued from the trials due to disease progression or toxicity, Rosenzweig said in an email. "Clinical trials can be seen as a great treatment option that offers hope. Often these are offered after traditional therapy has not been effective in controlling the disease. The concerns of the patients as they realize the implication of the trial discontinuation are beautifully documented in this article. Patients report a feeling of being frightened and somewhat adrift, without clear counseling regarding their disease status and 'what comes next'."

Rosenzweig says she sees this in her practice.

"There is a great deal of hope associated with clinical trial enrollment, particularly for patients who have been so disappointed by previous treatments and disease progressions," she said. "When the clinical trial needs to be discontinued - that is very disappointing and, in some cases, demoralizing to the patient and family. When the trial needs to be stopped for disease progression - there is an immediate fear among patients who realize that treatment will be needed quickly. If the trial needs to be stopped for toxicity, there is the additional burden of recovering from the toxicity that occurred. If the patient elects to go to another treatment option following the clinical trial, there can be a sense of worry that the treatment does not offer much hope for efficacy."

SOURCE: https://bit.ly/3saUQnB JAMA Network Open, online August 11, 2021.

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