Aileen B. Chen

Background: We recently completed the efficacy testing of an instructor-led yoga program for patients with thoracic cancer undergoing radiotherapy and their family caregivers. Translating an instructor-led intervention to a mobile app–based delivery model may facilitate the implementation of this yoga program in routine oncological clinical care. Objective: The current study seeks to develop a prototype of the app-based yoga program using a user-centric approach. Methods: Ten patients with a primary diagnosis of lung or esophageal cancer and their family caregivers (N=20) participated in structured interviews. Half of the sample had previously participated in the instructor-led yoga program, whereas half of the sample did not. Participants provided feedback on various mock-ups, wireframes, and yoga videos to guide the development of the app’s content, features, and workflow. Results: All patients (60% male; 70% non–Hispanic White; age: mean 62 years; 90% stage III) and their caregivers (90% female; 50% non–Hispanic White; age: mean 52 years) indicated that developing an app-based program is important and useful. Of the 20 participants, 95% mentioned that having an initial orientation with a yoga interventionist is important, and 90% stated that at least 1 check-in should be available (65% desired weekly check-ins). Participants provided feedback on characteristics of the instructor and instruction preferences. Other desired features included scheduling sessions on a calendar (95%), monitoring progress (95%), receiving practice reminders (90%), providing education on yoga as symptom management (90%), and providing daily inspiration (85%). All participants indicated the importance of including practices of various lengths. Conclusions: Both patients and caregivers deemed an app-based yoga program useful. Regardless of their level of yoga experience, almost all participants desired at least some contact with a live yoga instructor, although the desired frequency varied. These data have informed the development of a prototype that we are currently field-testing to ensure feasibility and acceptability.

PURPOSE: Patients with advanced thoracic cancers undergoing standard radiotherapy (RT) have a high risk of experiencing performance declines and poor quality of life (QOL). Exercise programs may improve objective and subjective performance; yet, adherence remains poor. Including family caregivers as active intervention, participants may improve adherence and thus efficacy. Thus, this clinical trial seeks to examine the efficacy of a patient-caregiver dyadic yoga intervention relative to a dose-matched education/support (ES) intervention. MATERIALS AND METHODS: Patients with lung or esophageal cancer undergoing at least 5 weeks of RT and their family caregivers were randomly assigned to either a 15-session yoga or ES comparison intervention. Patients and caregivers were assessed at baseline (T1), the last day of RT (T2) and 1 (T3), 2 (T4), and 3 (T5) months later. Patients completed the 6-minute walk test (6MWT; primary outcome) and both patients and caregivers completed a validated QOL measure (secondary outcomes). RESULTS: A total of 222 participants were randomly assigned. For the 6MWT, patients in the yoga group performed significantly better than those in the ES group across T2-T5 (least squared means [LSMs] in meters: yoga = 469 v ES = 441, P = .03). Patients in the yoga group also reported improved physical (LSMs: yoga = 44.7 v ES = 41.6, P = .03) but not mental QOL scores across T2-T5 compared with those in the ES group. As exploratory outcomes, patients in the yoga group also reported improved sleep ( P = .01) and coping efficacy ( P = .02). CONCLUSION: Yoga significantly improves functional capacity and subjective physical QOL in patients undergoing thoracic RT. Involving a family caregiver may improve intervention adherence.

BACKGROUND We recently completed the efficacy testing of an instructor-led yoga program for patients with thoracic cancer undergoing radiotherapy and their family caregivers. Translating an instructor-led intervention to a mobile app–based delivery model may facilitate the implementation of this yoga program in routine oncological clinical care. OBJECTIVE The current study seeks to develop a prototype of the app-based yoga program using a user-centric approach. METHODS Ten patients with a primary diagnosis of lung or esophageal cancer and their family caregivers (N=20) participated in structured interviews. Half of the sample had previously participated in the instructor-led yoga program, whereas half of the sample did not. Participants provided feedback on various mock-ups, wireframes, and yoga videos to guide the development of the app’s content, features, and workflow. RESULTS All patients (60% male; 70% non–Hispanic White; age: mean 62 years; 90% stage III) and their caregivers (90% female; 50% non–Hispanic White; age: mean 52 years) indicated that developing an app-based program is important and useful. Of the 20 participants, 95% mentioned that having an initial orientation with a yoga interventionist is important, and 90% stated that at least 1 check-in should be available (65% desired weekly check-ins). Participants provided feedback on characteristics of the instructor and instruction preferences. Other desired features included scheduling sessions on a calendar (95%), monitoring progress (95%), receiving practice reminders (90%), providing education on yoga as symptom management (90%), and providing daily inspiration (85%). All participants indicated the importance of including practices of various lengths. CONCLUSIONS Both patients and caregivers deemed an app-based yoga program useful. Regardless of their level of yoga experience, almost all participants desired at least some contact with a live yoga instructor, although the desired frequency varied. These data have informed the development of a prototype that we are currently field-testing to ensure feasibility and acceptability. CLINICALTRIAL

Objective: Patient-reported outcomes (PROs) contain valuable information that can be leveraged by providers to perform timely interventions and improve quality of life and survival. However, the implementation of electronic PROs (ePROs) remains a challenge from technical and evaluation perspectives. Our objective was to construct a robust electronic health record (EHR)-integrated ePRO information infrastructure founded on RE-AIM (reach-effectiveness-adoption-implementation-maintenance) principles. Materials and Methods: We used Epic Systems as our EHR platform to build the MD Anderson Symptom Index Head and Neck Module (MDASI-HN) for release to all patients undergoing evaluation and/or treatment in our HN Radiation Oncology clinics. RE-AIM metrics were established and used to design patient, provider, and implementing facilitator information tools. Results: From January 2021 to July 2024, our ePRO program has collected 13,156 patient-submitted ePROs on 3,497 unique HN patients, with a 12-month sustained ePRO compliance rate of 82%. We also propose a dynamic 2-cycle implementation model. This model can be used to continuously (re)define, build, and adapt ePRO information tools for patients, providers, and program facilitators. Discussion: Our ePRO framework has several benefits, including integrated clinical data for enhanced decision-making, potential scalability, and use of a common EHR system. Formative (ie, mid-phase) evaluations were essential to our program, allowing for timely optimization of ePRO compliance, ePRO usage by clinical staff, and secondary use of high-quality ePRO data. Conclusion: In this article, we provide a valuable roadmap toward developing a comprehensive, EHR-based ePRO information infrastructure simultaneously optimized for clinical utility, informatics operations, and implementation evaluation founded on RE-AIM principles.

Objective: Patient-reported outcomes (PROs) contain valuable information that can be leveraged by providers to perform timely interventions and improve quality of life and survival. However, the implementation of electronic PROs (ePROs) remains a challenge from technical, behavioral, and evaluation perspectives. Our objective was to construct a robust electronic health record (EHR)-integrated ePRO information infrastructure founded on RE-AIM (Reach-Effectiveness-Adoption-Implementation-Maintenance) principles. Materials and Methods: We used Epic Systems as our EHR platform to build the MD Anderson Symptom Index-Head and Neck Module (MDASI-HN) for release to all patients undergoing evaluation and/or treatment in our HN Radiation Oncology clinics. RE-AIM metrics were established and used to design patient-, provider-, and implementing facilitator information tools. Results: From January 2021 to July 2024, our ePRO program has collected 13,156 patient-submitted ePROs on 3,497 unique HN patients, with a 12-month sustained ePRO compliance rate of 82%. We also propose a dynamic clinical implementation-evaluation cycle. This model can be used to continuously (re)define, build, and adapt ePRO information tools for patients, providers, and program facilitators. Discussion: Our ePRO framework has several benefits including integrated clinical data for enhanced decision-making, potential scalability, and use of a common EHR system. Formative (i.e., mid-phase) evaluation and feedback were essential in our program, allowing for timely optimization of ePRO compliance, ePRO usage by clinical staff, and secondary use of high-quality ePRO data. Conclusion: In this article, we provide a valuable roadmap towards developing a comprehensive, EHR-based ePRO information infrastructure simultaneously optimized for clinical utility and implementation evaluation founded on RE-AIM principles.

Background/Objectives: This retrospective study evaluates outcomes of 66 patients who underwent reirradiation (re-RT) with proton beam therapy (PBT) for recurrent non-small cell lung cancer. Methods: Toxicity was scored via the CTCAE v5.0, and outcomes estimated using the Kaplan–Meier method, with associations evaluated via Cox proportional hazards and logistic regression analyses. Results: Patients were treated to a median re-RT prescription of 66 Gy/33 fxs (BED10 = 79 Gy; IQR: 71–84 Gy) at an interval of 1.4 years from prior RT. Half (50%) received concurrent chemotherapy. At 14 months follow-up, the median OS and PFS were 5 months (95%CI: 13–17) and 12.5 months (95%CI: 10–15), respectively. On multivariable analysis, a higher RT dose (BED10 > 70 Gy) [HR0.37; 95%CI: 0.20–0.68, p = 0.001] and concurrent chemotherapy (HR0.48; 95%CI: 0.28–0.81, p = 0.007) were associated with improved PFS, while treatment site overlap was adversely associated (HR1.78; 95%CI: 1.05–3.02, p = 0.031). The median PFS for definitive RT with concurrent chemotherapy (n = 28), definitive RT alone (BED10 > 70 Gy) [n = 22], and lower prescription RT (BED10 < 70 Gy) [n = 16] was 15.5 months (95%CI: 7.3–23.7), 14.1 months (95%CI: 10.9–17.3), and 3.3 months (95%CI: 0–12.3), respectively (log-rank, p = 0.006), with corresponding 2-year estimates of 37% (±9), 18% (±8), and 12.5% (±8), respectively. The incidence of Grade 3+ toxicity was 10.5% (6% pulmonary; 3% esophageal; and 1.5% skin), including one Grade 4 bronchopulmonary hemorrhage but no Grade 5 events. Cases with central site overlap had higher composite Dmax to the esophagus (median 87 Gy [IQR:77–90]), great vessels (median 120 Gy [IQR:110–138]), and proximal bronchial tree (median 120 Gy [IQR:110–138]) as compared to other cases (p ≤ 0.001 for all). However, no significant associations were identified with Grade 3+ events. Conclusions: Thoracic re-RT with PBT is an option for recurrent NSCLC with acceptable outcomes and toxicity for select patients. When feasible, higher prescription doses (BED10 > 70 Gy) should be delivered for definitive intent, and concurrent chemotherapy may benefit individual cases.

Background BMS-986156 is an agonist of the glucocorticoid-induced tumor necrosis factor receptor (TNFR)-related protein (GITR) and promotes increased effector T-cell activation. Combined anti-GITR, anti-programmed death-1, anti-cytotoxic T-lymphocyte-associated protein 4 antibodies and radiotherapy improve tumor control in preclinical studies. Herein we describe the results of the safety and efficacy of BMS-986156+ipilimumab or nivolumab with/without stereotactic ablative radiotherapy (SABR) in patients with advanced solid cancers (NCT04021043). Methods This open-label, multigroup, single-center phase I/II study enrolled patients with histologically-confirmed stage IV solid cancers resistant to standard treatments. Group 1 (G1, n=20) received four cycles of ipilimumab (3 mg/kg) plus BMS-986156 (30 mg as dose level 1 (L1) or 100 mg as dose level 2 (L2)), every 3 weeks (Q3W). Group 2 (G2, n=10) received four cycles of ipilimumab (3 mg/kg) plus BMS-986156 (dose as determined in G1, Q3W) with SABR (50 Gy/4 fx or 60–70 Gy/10 fx to liver/lung lesions. Group 3 (G3, n=20) received four cycles of nivolumab (480 mg) plus BMS-986156 (30 mg), every 4 weeks with SABR. Maintenance nivolumab could be given up to 2 years. Tumor responses were assessed every 1–3 months until progression, using immune-related response criteria. Results 50 patients were enrolled between 10/2019 and 12/2021. Patients received a median of 3 (IQR 2–4.25) initial treatment cycles. 100 mg BMS-986156 with ipilimumab was tolerated well. Five discontinued BMS-986156 with ipilimumab due to treatment-related adverse events (TRAEs), with three in G1/L1, one in G1/L2 and one in G2, respectively. 22 patients (44%) experienced Grade 1–3 TRAEs (6, 4, 5, 7 patients for G1/L1, G1/L2, G2, G3). Six (12%) had Grade 3 TRAEs (2, 2, 1, 1 for G1/L1, G1/L2, G2, G3), with elevated alanine aminotransferase (n=3, in G1/L2, G2 and G3) and aspartate aminotransferase (n=2, in G2 and G3) being the most common. There was no Grade 4–5 TRAEs. Overall, 19/39 (48.7%) patients eligible for efficacy analysis had stable disease and 3 (7.7%) achieved a partial response. Out-of-field (abscopal) disease control rate (ACR) and out-of-field (abscopal) response rate (ARR) were 38.5% and 7.7%, respectively, with the highest ACR (50%, 9/18) and ARR (11.1%, 2/18) in G3. Conclusions BMS-986156 was well-tolerated with ipilimumab, nivolumab, with or without SABR. Outcomes were encouraging in this population, as more than half of patients had stable disease/partial response.

Background: Adult attachment insecurity is associated with poor psychosocial and cancer-related symptom outcomes in patients with cancer; however, there is a paucity of research around the role of the spousal caregivers' attachment in patient quality of life (QOL) at the end of life (EOL). Attachment styles may be particularly relevant for couples coping with prolonged metastatic disease, where the threat of death or disease progression is highly salient. Methods: We conducted secondary analyses on a sample of patients with stage IV non–small cell lung cancer and their spouses. Participants separately completed questionnaires of attachment style (ECR-S), relationship closeness (PAIR), illness-related communication (holding back one's fear of death or disease progression), and cancer-related distress (IES). Patients additionally completed questionnaires on sense of life completion and QOL at EOL (QUAL-E Completion Subscale and Overall QOL Item) and symptom burden (MDASI-LC). Results: For patients, greater attachment avoidance was associated with lower sense of life completion (r = −0.31, P = .009) and lower overall QOL (r = −0.35, P = .003). Greater patient attachment anxiety was also associated with a lower sense of life completion (r = −0.26, P = .034). Greater caregiver attachment avoidance and attachment anxiety were associated with patient reports of lower overall QOL (r = −0.38, P = .001, r = −0.36, P = .002, respectively). In addition, greater caregiver attachment anxiety was associated with greater patient symptom burden (r = 0.24, P = .048) controlling for patient's own attachment anxiety. For both patients and caregivers, greater attachment anxiety was associated with more “holding back” from communicating their fear of death or disease progression with their spouse (r = 0.25, P = .036; r = 0.31, P = .011, respectively). Dyadic analyses revealed a positive association within the couple for attachment avoidance (r = 0.41, P < .01) and anxiety (r = 0.31, P < .01). Conclusion: Both spousal caregiver and patient attachment styles are highly relevant to illness communication patterns and patient QOL outcomes.

Purpose In efforts to understand financial distress (FD) associated with advanced cancer care from the perspective of both patients with incurable disease and their spousal caregivers, we assessed FD in both members of the couple, identified symptom and quality of life (QOL) correlates, and examined the potential role of illness communication. Methods Patients undergoing treatment for stage III/IV lung cancer or a grade III/IV primary brain tumor and their spousal caregivers (n = 76 dyads) completed measures of somatic and affective symptoms including FD, physical and mental QOL, and ease of engaging in illness communication. Patients and caregivers additionally rated their perception of each other’s symptoms, including FD. Results FD was endorsed by both patients (any FD 62.7%; high FD 24%) and spousal caregivers (any FD 64.7%; high FD 32.3%). Self-reported FD was significantly correlated (partial r = .52, p < .001) within couples. FD was associated with greater symptoms of anxiety (r = .29, p = .01; r = .31, p = .01), depression (r = 29, p = 01; r = .39, p = .001), and poorer physical QOL(r = − .25, p = .03; r = − .25, p = .001) for patients and caregivers, respectively. For patients, FD was additionally associated with poorer mental QOL(r = − .44, p < .001). Caregivers accurately perceived patient FD, yet patients tended to underreport their caregiver’s FD by almost an entire point (t = 2.8, p = .007). A 3-way interaction (FD X role X illness communication) revealed (b = .40, p = .041) that illness communication moderated the association between FD and physical QOL for spouses so that spouses who reported less ease of illness communication demonstrated a stronger association between financial distress and physical QOL (b = − 2.08, p < .001) than those reporting greater ease of engaging in illness communication (b = .49, p = .508). Conclusion In the advanced cancer setting, FD is prevalent in both patients and their spousal caregivers and associated with psychological distress and poor physical QOL. Results suggest that optimal FD assessment should include patients and spouses, and spouse’s ease of engaging with illness communication may be a potential target for future intervention studies.