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We have previously shown that interruptions of definitive radiotherapy (RT) detract from treatment efficacy and that step count data from wearable devices can be utilized to predict treatment interruptions. We performed a randomized trial to test the hypothesis that utilizing wearable devices to monitor and increase patients' physical activity during RT can reduce the risk of treatment interruption. Patients with an ECOG performance status (PS) of 0-2 who were planned for a course of definitive radiotherapy with concurrent chemotherapy were eligible for this randomized trial. All participants received a commercial activity monitor prior to treatment initiation and received standard supportive care throughout treatment. As in previous studies, patients with baseline daily step count average below the 25 th percentile of age-matched controls were considered "inactive." Experimental arm participants were asked to meet a personalized daily step count displayed on the device. Those who repeatedly failed to meet their step count goal received reminders to increase step counts from the study team. The primary endpoint was missing two or more scheduled RT sessions. Secondary endpoints included hospitalizations, disease progression, and death. One hundred sixty-six participants were enrolled from 2017-2020. After excluding subjects whose treatment plan changed after enrollment and those who withdrew consent, 141 patients remain for analysis. Mean age was 60, 95% of participants had PS 0-1, and 50% of participants were categorized as inactive at baseline. The most common diagnoses were head and neck cancer (27%) and lung cancer (26%). Experimental arm participants were less likely to miss two or more RT sessions (19% vs. 31%, p = 0.107) and to be hospitalized during RT (14% vs. 24%, p = 0.169), though these effects did not reach statistical significance. Subgroup analyses suggested that the study intervention reduced treatment interruptions in male patients (13% vs. 33%, p = 0.043) and in patients with head and neck cancer (24% vs. 57%, p = 0.037). Participants who were inactive at baseline were more likely to miss two or more scheduled RT sessions (37% vs. 13%, p = 0.002) and to be hospitalized during RT (27% vs. 7%, p = 0.003). While our primary study objective was not achieved, a simple pedometer-based walking intervention may reduce the incidence of treatment interruptions and hospital admissions during treatment. Baseline activity level was identified as a powerful predictor of treatment interruption and hospital admission. Future studies will focus on supervised physical activity interventions and providing enhanced supportive care to patients found to be at high risk for treatment complications based on activity metrics. [ABSTRACT FROM AUTHOR]

Initial reports from the S elective P ersonalized R adioimmunotherapy for Locally Advanced N SCLC T rial (SPRINT) indicated that patients with high PD-L1 expression can be treated safely and effectively with immunotherapy and radiotherapy (RT). Here, we compare patient-reported outcomes (PROs) from SPRINT to PROs from patients who were treated with standard concurrent chemoradiotherapy on contemporary prospective trials to test the hypothesis that the SPRINT approach yields favorable patient-reported outcomes. SPRINT participants with PD-L1 tumor proportion score ≥ 50% were treated with "PembroRT": three 21-day cycles of induction pembrolizumab, a four-week course of risk-adapted and de-intensified RT (55 Gy to tumors or lymph nodes measuring 20 cc or larger and 48 Gy to smaller lesions, all in 20 fractions and without concurrent chemotherapy), and up to 13 cycles of consolidation pembrolizumab. SPRINT participants with lower PD-L1 expression and participants on the control arm of NCT03481114 were treated with "ChemoRT": a standard RT dose of 60 Gy in 30 fractions with concurrent weekly carboplatin and paclitaxel and standard adjuvant therapy (e.g., durvalumab). Participants in both trials completed a 12-item PRO-CTCAE survey at baseline, every two weeks during RT, and at follow-up visits. Study participants who completed the planned RT course and completed at least two PRO-CTCAE surveys were included in this analysis. Peak PRO-CTCAE grades recorded up to 90 days after RT completion were compared across treatment cohorts using Kruskal-Wallis testing. Multivariable logistic regression models were utilized to evaluate predictors of grade 2+ patient-reported toxicity. Kaplan-Meier curves and log rank testing were utilized to compare progression-free survival (PFS) and overall survival (OS) across treatment cohorts. The PembroRT cohort included 19 patients, and the ChemoRT cohort included 26 patients. Mean esophagus and lung doses were significantly lower in the PembroRT cohort, with median values approximately 5 Gy lower than in the ChemoRT group. Average PRO-CTCAE grades were numerically higher in the ChemoRT group for all 12 symptoms, with statistically significant differences observed for cough, wheezing, dermatitis, dizziness, anxiety, and depression. Multivariable models demonstrated that patient-reported toxicity was generally not associated with chemotherapy receipt, while several patient-reported adverse events were associated with organ at risk doses. For example, grade 2+ dysphagia incidence was associated with mean esophageal dose. The PembroRT cohort had superior 3-year rates of PFS (61% v. 23%, P = 0.033) and OS (88% v. 49%, P = 0.013). Compared to standard chemoradiotherapy, the SPRINT treatment approach, which utilizes induction immunotherapy to reduce target volumes and risk-adapted RT, can improve patient-reported outcomes without compromising clinical outcomes. [ABSTRACT FROM AUTHOR]

Despite association between distress and worsened overall survival, little is known about specific causes of distress. The primary objective of this study was to identify stressors in patients with cancer receiving curative intent radiation therapy (RT) at a racially/ethnically diverse urban academic center. A secondary objective sought to evaluate the coping mechanisms used by these patients. This prospective, IRB approved, single institution, mixed methods study enrolled a pre-planned sample of 40 patients between 4/2021 and 2/2022. Distress was measured via the NCCN recommended Distress Thermometer (DT); specific stressors were determined using the Cancer Treatment and Distress Scale (CTDX) and coping methods using the Brief Cope (BC). All three questionnaires were completed prior to starting RT. Post-RT questionnaires and interview data is not yet mature and will not be reported here. DT was evaluated as both a continuous and dichotomized variable with a score of≥4 being distressed. Chi-squared, Wilcoxon rank-sum, and Pearson correlation tests were used, as appropriate, to assess these relationships. 39 patients completed study questionnaires. Patients predominantly self-identified as female (62%) and a minority (39% African American, 37% Hispanic). Of the 23 patients who reported their income, 52% had an annual income ≤$40,000. Most cancers were early stage (47% stage I-II) with the most common cancer types of breast (31%), prostate (23%), and gynecological (18%). 76% of patients reported feeling distressed (median 6, IQR 4-8). The strongest correlations between the DT and the CTXD, were related to health burden (physical limitations due to disease and treatment) (r=0.64, p<0.001) and uncertainty about the future/disease course (r=0.61, p<0.001). When evaluating coping strategies, higher DT scores (r=0.40, p=0.030) were associated with increased likelihood of using avoidant coping styles such as self-distraction, denial, and substance use. There was no association between feeling distressed and gender, race/ethnicity, income, receiving surgery or chemotherapy prior to RT, nor receiving concurrent chemoradiation. We found >75% endorsed clinical levels of distress, which is much higher than the ≤50% seen in predominantly white populations. These results suggest there is an opportunity to dramatically reduce distress in these economically disadvantaged cancer patients. Potential approaches for distress reduction could include targeted interventions such as pre-emptive rehabilitation medicine to improve physical function, an iterated education program based on patient understanding to ameliorate uncertainty, and mindfulness therapy to develop effective coping strategies. [ABSTRACT FROM AUTHOR]