Cancer Clinical Trial Enrollment Is Low in the US, and Patient Depression and Anxiety May Play a Role

Depression and anxiety may majorly impact the cancer experience, and according to recent study results, it may even deter patients with hematologic malignancies from participating in cancer clinical trials.

“There are many systemic and person-level factors that can contribute to this lack of engagement. … However, another contributing factor that can impact participation is attitudinal barriers such as fear-based perceptions about what it means to participate in a clinical trial,” study author Victoria Morris, research director at Cancer Support Community, said while presenting findings at the 2021 ASH Annual Meeting.

Morris and her team surveyed 625 patients with blood cancers about their sociodemographic and clinical status, as well as feelings on eight statements about clinical trials, which were ranked on a scale of 0 (strongly disagree) to 4 (strongly agree). Another survey measured their anxiety and depression levels on a five-point scale.

The study sample was made up of the following blood cancer types: 46.4% myeloma; 19.5% chronic lymphocytic leukemia; 11.4% non-Hodgkin lymphoma; 4.0% acute myeloid leukemia; 3.5% Hodgkin lymphoma; 3.2% chronic myeloid leukemia; 1.6% acute myeloid leukemia; 1.3% myeloproliferative neoplasm; 7.4% other lymphoma; and 1.8% other leukemia.

Upon analyzing the results, the researchers showed that depression and anxiety levels significantly influenced seven out of the eight clinical trial perceptions.

“Depression and anxiety — two psychosocial factors that are highly prevalent in the cancer space — can bias attention in ways that alter perceptions, thus potentially playing a role in trial perceptions,” Morris explained.

Depression and anxiety were predictors of the following perceptions:

• “I am uncomfortable being randomly assigned.” (53% of patients responded “agree” or “strongly agree”)
• “I fear receiving a placebo (for example, a sugar pill) in a clinical trial.” (49%)
• “I fear side effects that might come with treatment on a clinical trial.” (46%)
• “I would be unable to fulfill trial requirements due to logistical barriers.” (15%)
• “There are no clinical trials available in my community.” (20%)
• “I don’t trust the medical establishment and fear I will be used as a ‘Guinea pig.’” (13%)
• “I don’t understand what clinical trials are.” (8%)

“These perceptions and fears can impact their decision on whether or not to pursue a clinical trial,” Morris said.

The only perception that anxiety and depression did not have an effect on, however, was the belief that insurance would not cover the clinical trial.

Despite the existence of thousands of cancer clinical trials available, only about 2% to 7% of patients with cancer in the United States participate in them, according to Morris. She explained that while most efforts aimed at increasing trial participation focus on patient education, depression and anxiety must be considered, according to these findings.

“While attempts to alter perceived barriers to participation in cancer clinical trials often focus on information dissemination to address misconceptions about cancer clinical trials, the present study indicates that underlying person-level psychological factors may shape perceptions about cancer clinical trials and need to be considered,” Morris said.

Morris said that she hopes that this is the first study of many that analyzes how depression and anxiety affect clinical trial perceptions and enrollment.

“One thing is clear: the decision about whether to engage in cancer clinical trials is complex and multi-faceted and any and all barriers to participation need to be considered so that we can better empower patients in their treatment decision making,” she concluded.

A version of this article was originally published on OncLive as, “Depression, Anxiety Affect Patient Perceptions of Cancer Clinical Trials.”

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