Patient Mental Health Key Factor in Cancer Clinical Trial Perception

Victoria Morris, PhD

When patients with cancer experience depression and anxiety, they are less likely to enroll in oncology clinical trials, according to findings presented at the 2021 American Society of Hematology Annual Meeting and Exposition.¹

“Although thousands of cancer clinical trials are available today, engagement remains low, with only 2% to 7% of cancer patients in the United States participating in cancer clinical trials,” study author Victoria Morris, PhD, research director at the Cancer Support Community, said while presenting the findings. “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 cancer clinical trial.”

The observational, cross-sectional study involved 625 patients with blood cancer (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).

Participants filled out Cancer Support Community’s Cancer Experience Registry, which includes sociodemographic and clinical data as well as ranking on a scale of 0 (strongly disagree) to 4 (strongly agree) on 8 statements about clinical trials. Participants also completed the Anxiety and Depression subscales from the Patient-Reported Outcomes Measurement Information System (PROMIS-29v2.0).

PROMIS responses were averaged to determine the level of depression and anxiety on a 5-point scale, while 8 hierarchical regression models were examined—one for each of the clinical trial perception variables—to determine the impact that depression and anxiety had on how patients think of clinical trials. Clinical history and sociodemographic variables were controlled for.

“Regression models indicated that psychosocial distress comprised of both depression and anxiety accounted for a significant amount of variance in 7 of the 8 clinical trial perceptions, above and beyond the controls,” Morris said. “Depression and anxiety—2 psychosocial factors that are highly prevalent in the cancer space—can bias attention in was that alter perceptions, thus potentially playing a role in trial perceptions.”

The average anxiety and depression score was 1.91 (SD = .93). These psychosocial effects were predictors for the following perceptions:

• “I would be unable to fulfill trial requirements due to logistical barriers.” (15% of participants responded “agree” or “strongly agree”; P = .003)
• “I don’t trust the medical establishment and fear I will be used as a ‘Guinea pig.’” (13%; P = .006)
• “I am uncomfortable being randomly assigned.” (53%; P = .01)
• “I fear receiving a placebo (for example, a sugar pill) in a clinical trial.” (49%; P = .024)
• “I don’t understand what clinical trials are.” (8%; P = .021)
• “There are no clinical trials available in my community.” (30%; P = .03)
• “I fear side effects that might come with treatment on a clinical trial.” (46%; P = .047)

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

These findings show that clinicians should consider psychosocial barriers when discussing the options of clinical trial participation to patients.

“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.

This study should just be the first of more research that should analyze the magnitude and directionality of these findings, according to Morris.

“But one thing is clear: the decision about whether to engage in a cancer clinical trial 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.”

Reference

1. Rogers K, Morris V, Miller M, LeBlanc T. The relationship between depression, anxiety, and clinical trial perceptions among patients with hematologic cancer. Presented at: 2021 ASH Annual Meeting and Exposition; December 11-14, 2021; Atlanta, GA. Abstract 1901.