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Introduction: Anxiety and dyspnea are 2 common symptoms for lung cancer survivors. Although research suggests decreasing respiration rate can reduce anxiety in several populations, potential benefits of device-guided breathing have not been studied in lung cancer survivors. This feasibility study (WF-01213) provides estimates of accrual, adherence, retention, and preliminary efficacy of 2 doses of a device-guided breathing intervention versus a usual breathing control group for improving self-reported anxiety and dyspnea in post-treatment lung cancer survivors. Methods: Stage I-IV lung cancer survivors were recruited through the NCI Community Oncology Research Program (NCORP) and randomized to 12 weeks of a device-guided breathing intervention (high dose vs. low dose) or control device. Self-reported outcomes (anxiety, depression, dyspnea, cancer-related worry, fatigue) were assessed at baseline, mid-intervention (Week-6), and post-intervention (Week-12). Results: Forty-six participants (ages 41-77, median = 65; 78% White) were randomized to the high-dose intervention (n = 14), low-dose intervention (n = 14), or control (n = 18) groups between July 2015 and September 2019. Study accrual rate was 0.92 per month for 50 months (projected accrual was 6.3/month). Fourteen participants (30%) withdrew early from the study, with almost half of those discontinuing at or immediately following baseline assessment. No participants were adherent with the intervention per protocol specifications. The proportion minimally adherent (using device at least 1x/week) was 43% (6/14), 64% (9/14), and 61% (11/18) for high-dose, low-dose, and control groups, respectively. Anxiety significantly decreased from baseline for all groups at Week 12. Adherence to the intervention was low across all treatment groups. Conclusions: This study did not establish feasibility of a community-based randomized trial of 2 doses of device-guided breathing and a control group using an identical-looking device for lung cancer survivors. In both the high-dose and control groups, there were significant improvements from baseline for anxiety and dyspnea. In the low-dose group, there were significant improvements from baseline for anxiety and depression. Ratings and feedback on the intervention were mixed (although leaned in a positive direction). Participants reported liking the feeling of relaxation/calm, helping others, breathing awareness, and music. Participants reporting liking least finding/making time to use the device, frustration with the device, and completing study forms. Trial Registration: Clinical Trials ID: NCT02063828, clinicaltrials.gov.

Background Insomnia is a toxicity of cancer and treatment for survivors without an objective biochemical measure. Circadian rhythms are 24-h cycles that influence physiologic processes including sleep, and disrupted rhythms may contribute to insomnia. Here, we use BloodCCD to assess circadian rhythms from RNA-sequencing of blood from cancer survivors with insomnia from the YOCAS-II trial. YOCAS-II aimed to determine whether YOCAS©® yoga or cognitive behavioral therapy for insomnia (CBT-I) improved insomnia in survivors compared with a behavioral placebo. We hypothesized that circadian rhythms are disrupted in survivors, and that insomnia severity correlates with the degree of circadian disruption. Methods BloodCCD was developed to biochemically assess circadian rhythms in blood. It was adapted from the previously published Clock Correlation Distance (CCD) and uses a correlation matrix of 42 genes known to oscillate throughout the day in blood. Results Cancer survivors had higher (worse) BloodCCD scores, indicating disrupted circadian clock, compared to healthy individuals. Furthermore, insomnia severity correlated with worse BloodCCD, and those in the YOCAS and behavioral placebo arm showed significant correlation between BloodCCD score and insomnia. Conclusions BloodCCD shows promise as a biomarker to biochemically detect disrupted circadian rhythms in cancer survivors, and as an indicator for insomnia severity. Clinical Trial Identifier NCT02613364.

To the Editor: The review of renal-cell carcinoma by Cohen and McGovern (Dec. 8 issue) 1 was extensive but did not discuss radiotherapy. As noted in the article, nearly half the patients with renal-cell carcinoma have metastatic disease on presentation or will have a recurrence. Conventional radiotherapy has been an effective palliative treatment for most sites of metastatic renal-cell carcinoma, including lung, bone, and soft tissues. 2 In particular, stereotactic radiosurgery has been reported to have local control rates for brain metastases of more than 85 percent. 3 Recently, stereotactic radiosurgery for spinal metastases has demonstrated high efficacy in pain relief with minimal . . .

[Bruno Vincenzi, M.D.] and colleagues would have preferred that we were more definitive in recommending high-dose interleukin-2 as first-line therapy over subcutaneous, low-dose interleukin-2. We agree that high-dose interleukin-2 is the preferred approach for treatment of metastatic or locally advanced renal-cell carcinoma on the basis of published data. However, not all patients can tolerate high-dose interleukin-2.