P15.20.B CALM IN THE FACE OF BRAIN CANCER: INTERIM ANALYSIS OF A RANDOMIZED CONTROLLED FEASIBILITY TRIAL FOR NEURO-ONCOLOGY PATIENTS WITH ELEVATED PSYCHOLOGICAL DISTRESS

Abstract BACKGROUND Both patients with primary and secondary brain tumors experience substantial psychological distress but have historically been excluded from psychological research. Managing Cancer and Living Meaningfully (CALM), a supportive-expressive psychotherapy, has proven to reduce depression and death anxiety in advanced cancer patients, but trials in neuro-oncology have been limited. Due to potential concerns regarding recruitment and retention among this unique population, we conducted a randomized feasibility pilot trial. This report describes interim feasibility and acceptability analyses of the first pilot randomized controlled trial (RCT) of CALM in neuro-oncology. MATERIAL AND METHODS In this ongoing NIH ORBIT model Phase IIc pilot RCT, 60 adults with primary or secondary malignant brain tumors and elevated distress (depression and/or death anxiety) are randomized (2: 1) to a six-session CALM intervention or usual care (UC; i.e., referrals to local/national resources). Online survey data were collected at baseline, 3 months (post), and 6 months (follow-up) across both arms. A priori benchmarks were set to assess feasibility and acceptability: rates of enrollment (>30%), assessment completion (post=>70%, follow-up=>60%), perceived benefit (>4/5), and recommendation of CALM (>75%). RESULTS A multimodal national recruitment model has screened 105 patients, of which 69 were eligible and 60 enrolled (87% enrollment rate; 67% female; 88% White; Mage=52). Current overall assessment completion rates are 77% at post (n=40/52; 77% CALM, 76% UC) and 69% at follow-up (n=33/48; 67% CALM, 69% UC), with 8 participants still undergoing study procedures. For those randomized to CALM (n=39), perceived benefit appears high (M=4/5 rating), and all CALM participants (100%) report they would recommend the intervention to others with malignant brain tumor. CONCLUSION We far surpassed our benchmark enrollment rate and achieved our target sample size, reflecting feasibility of our multimodal national recruitment approach spanning local efforts, outreach to neuro-oncology providers, and social media and patient advocacy groups. Though we have yet to complete our data collection period for 3- and 6-months, interim metrics are above target retention benchmarks across both arms. Intervention acceptability among those randomized to CALM is high. The secondary aim of this trial is to examine rates of clinically significant change with respect to depression and death anxiety; in combination with our feasibility and acceptability data, this will inform our planned randomized effectiveness trial of CALM in neuro-oncology.