In this pilot feasibility and randomized controlled trial of brief CBT tailored to patients with anxiety comorbid with terminal cancer, we found that the majority of participants in the sample was able to complete the intervention despite expected declines in physical health status associated with disease progression and toxicities from medical treatment. Moreover, we observed beneficial effects of the therapy for reducing anxiety symptoms and improving certain aspects of quality of life over time.
Patients with poor-prognosis cancers are at heightened risk for psychiatric morbidity and suffer considerable disease burden that may limit their ability to engage in psychosocial services [31
]. Considering the disability associated with terminal cancers, we modified the delivery of our CBT intervention in several ways to accommodate patients' needs. Specifically, we reduced the number of sessions to 6–7 from the standard 12–15 visits often reported in psychotherapy trials for anxiety because of the constraints imposed by patients' shortened life expectancies. Notably, of the 20 participants assigned to the waitlist control group, only 9 completed the CBT intervention after the 2-month time point, primarily because of worsening disease that limited further participation, underscoring the importance of timely access to care.
To enhance retention, more than half of all CBT visits took place on the same day as other medical appointments, during chemotherapy infusions, or via telephone. These adaptations to standard clinical practice are often necessary when working with seriously ill patients. Investigators have begun examining alternate approaches to the delivery of CBT for individuals with cancer, such as through home-based visits, videoconferencing, and the telephone [32
]. The results of the present study suggest that such accommodations may contribute to intervention effectiveness.
Despite the obstacles associated with treating a medically complex population, our study demonstrated statistically significant effects of brief CBT for reducing anxiety symptoms per blinded-clinician and patient reports. Across anxiety measures, effect sizes of change were large, highlighting the clinical utility of the brief treatment approach for helping patients cope with realistic cancer-related worries. However, we observed no significant differences between groups in depression from baseline to posttreatment assessment, in part because the variability in MADRS ratings was larger in the CBT group compared to the control group. Self-reported depression symptoms on the HADS appeared to lessen over time in the entire sample overall.
Our findings are consistent with the work of Moorey and colleagues, who conducted a cluster-randomized controlled trial demonstrating the benefit of CBT for reducing anxiety symptoms but not depression in home care patients with advanced cancer receiving palliative care [32
]. We believe the targeted approach we have employed to treat anxiety in patients with terminal cancer would require specification for alleviating depression, perhaps by addressing demoralization and hopelessness, which strongly correlate with mood symptoms in this population [35
Without medical intervention, patients with terminal cancer experience declines in physical health status over time, which impair quality of life. In the present trial, the two study groups did not differ with respect to change in overall quality of life, but a finer analysis of the subscales revealed a more nuanced picture of this outcome. Despite decrements in physical well-being over time, we observed marginally significant improvements in emotional and functional well-being among those assigned to CBT compared to the waitlist control group. The large effect sizes and 2- to 3-point changes on these respective subscales of the FACT-G are clinically meaningful [37
]. Although we urge caution in interpreting these results given the small sample, perhaps the acceptance-based and activity-pacing components of our tailored intervention enhanced coping with cancer [21
], allowing patients to experience less emotional distress and improved functioning even while the physical disease worsened. Using mindfulness interventions to increase acceptance requires further study and may have particular benefit for patients diagnosed with cancer, not simply for alleviating anxiety [13
] but also for buffering the expected declines in health-related quality of life.
Several limitations of the methods warrant attention. Because the study was a combined pilot feasibility and randomized controlled trial, we planned to enroll a small sample, aiming to achieve 30 study completers. Yet, the rate of accrual was low during the 3-year study period and attrition was high due to medical factors. Rather than relying on clinician referral, future studies would benefit from using routine screening procedures to identify patients with elevated anxiety symptoms in the oncology care setting. Additionally, the sample lacked racial and ethnic diversity, limiting the generalizability of intervention to minority patients. Moreover, we were able to meet patients in the chemotherapy infusion suite at the cancer center—a convenience that might be challenging to replicate in the community.
Although the results of our investigation are promising, a large-scale follow-up randomized controlled trial is necessary to confirm the efficacy and generalizability of the brief CBT intervention for patients with terminal cancers. Investigators of future psychosocial trials for anxiety in this population ought to consider the use of an attention-matched control group to ensure that CBT is the reason for the anxiety reduction, as well as alternative methods for delivering the intervention, such as web-based approaches, to increase access and dissemination. Finally, further work is needed to discern the optimal number of CBT sessions and whether the benefits of this intervention persist over the long term.
Despite the challenges of delivering a psychosocial intervention in this medically complex patient population, our study shows that CBT can be modified and tailored to address salient psychological needs of individuals with anxiety comorbid with terminal cancers. Although ongoing research is needed to ascertain the most effective methods for treating depression, brief CBT appears feasible and clinically beneficial for reducing suffering related to anxiety in patients with cancer who are coping with a terminal diagnosis.