Abstract
Abstract BACKGROUND Patients with high-grade glioma report substantial psychological distress, yet are frequently excluded from psycho-oncology research. Managing Cancer and Living Meaningfully (CALM) is an expressive-supportive psychotherapy designed to address the inevitable challenges that patients with advanced cancer face. CALM was shown in a large randomized controlled trial to reduce depression and death-related distress, but brain cancer was an exclusion criterion. METHODS In this ongoing ORBIT Model Phase Ib Refine trial, 10 adults with high-grade glioma and heightened distress (PHQ/DADDS) participated in CALM. Feasibility and acceptability were assessed based on established metrics, satisfaction was explored by surveys and exit-interviews, and preliminary efficacy of reducing distress was analyzed by pre to post-CALM paired t-tests; effect sizes estimated using Cohen’s d. RESULTS Of 11 patients referred and screened, 10 enrolled in the study (91% enrollment rate; 70% GBM; 70% female; M age =55yrs). Reasons for withdrawal was disinterest in intervention topics (n=2). Eight patients completed baseline assessments and at least one CALM session. To date, seven have completed treatment. Retention is 63%, with one participant still in active treatment. No adverse events were determined to be study-related. Perceived benefit was high (4.8/5), and all participants reported they would recommend program to others. Pre- to post-CALM analyses show medium-to-large effects on reducing depression (d=1.2), anxiety (d=.74), and death-related distress (d=.54). Small effects were seen for quality-of-life improvement (d=.26). Fear of cancer recurrence worsened (d=.75). CONCLUSIONS Preliminary data suggests that CALM is both feasible and acceptable in adult patients with high-grade glioma. Enrollment and retention rates were adequate. Patients reported high benefit and recommendation to others. Depression, generalized anxiety, and death-related distress all improved with medium-to-large effects, suggesting CALM may be a promising intervention for high-grade glioma patients as they navigate the challenges of brain cancer. Adjunctive treatment may be necessary to address fear of cancer recurrence.
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