Pachman, Deirdre R.

31 Background: Incidence of early-onset colorectal cancer (eoCRC, <50 years of age at diagnosis) is increasing globally. However, little is known regarding symptom burden in this sub-population. We compared symptoms in patients with eoCRC to those of patients with average-onset CRC (aoCRC, diagnosed at age ≥ 50). Methods: E2C2 is a stepped-wedge, cluster-randomized pragmatic trial evaluating a collaborative care model for the assessment and management of six symptoms [Sleep disturbance, Pain, Physical function impairment, Anxiety, emotional Distress, and Energy deficit (SPPADE)]. Patients were asked to complete assessments rating each of these symptoms on an 11-point numerical rating scale. Symptom severity was classified as mild (0-3), moderate (4-6), or severe (7-10). We conducted a subgroup analysis of patients with CRC, comparing SPPADE symptoms on an initial survey, regardless of timing in treatment course, between patients with eoCRC and aoCRC. Results: Patients with CRC (n=4281) completed a survey between March 2019 and December 2022. Patient demographics and SPPADE symptoms are reported in the table. Patients with eoCRC were more likely to report severe sleep disturbance ( p<0.0001), pain ( p=0.03485), anxiety ( p<0.0001), emotional distress ( p<0.0001), and fatigue ( p=0.01083). In patients with eoCRC, women were more likely to report severe pain (12.6% vs 6.9%, p=0.0069), anxiety (16.1% vs 10.0%, p=0.012), emotional distress (12.1% vs 5.4%, p=0.00066), fatigue (18.9% vs 13.4%, p=0.038), and physical function impairment (10.1% vs 5.8%, p=0.026) compared to men. Conclusions: Patients with eoCRC reported higher symptom severity than patients with aoCRC. This suggests unique needs for symptom management in patients with eoCRC. Additional research is needed to evaluate how time since diagnosis, disease characteristics, cancer-directed treatment patterns, and co-occurring symptoms are associated with specific symptoms in this population. [Table: see text]

AbstractCancer and its treatment produce deleterious symptoms across the phases of care. Poorly controlled symptoms negatively affect quality of life and result in increased health-care needs and hospitalization. The Improving the Management of symPtoms during And following Cancer Treatment (IMPACT) Consortium was created to develop 3 large-scale, systematic symptom management systems, deployed through electronic health record platforms, and to test them in pragmatic, randomized, hybrid effectiveness and implementation trials. Here, we describe the IMPACT Consortium’s conceptual framework, its organizational components, and plans for evaluation. The study designs and lessons learned are highlighted in the context of disruptions related to the COVID-19 pandemic.

Introduction: Medical trainees experience a high degree of stress that predisposes them to burnout. This pilot study tested a scalable approach to deliver a validated resilience program (Stress Management and Resiliency Training (SMART)) among Hematology/Oncology fellows at an academic medical center. Methods: This was a mixed-methods, prospective, single-arm clinical trial involving Hematology/Oncology fellows at Mayo Clinic in Rochester, MN, USA. Four one-hour training sessions were conducted virtually with 26 fellows. Stress, burnout, and emotional resilience were measured at baseline, three months, and six months post-intervention using the Perceived Stress Scale (PSS-10), Maslach Burnout Inventory (MBI-HSS), and Connor-Davidson Resilience Scale (CD-RISC2). Changes in mean scores were assessed using paired t-tests. Feasibility and acceptability data were obtained during a virtual focus group. Results: Statistically significant improvements in mean stress (p = 0.004) and professional achievement (p < 0.001) were seen at three months post-intervention. At six months post-intervention, mean stress (p < 0.001) and professional achievement (p = 0.032) continued to improve, while improvements in emotional exhaustion (p = 0.001) and depersonalization (p < 0.001) also became significant. Focus group participants found the program beneficial and reported improved stress and work performance as a result of participation. Conclusion: Virtual implementation of the SMART program is feasible and resulted in improvements in stress and burnout. Focus group participants found the training beneficial, reporting lower stress and improved work performance.

e13552 Background: Real-world data from Electronic Health Records (EHR) have been widely used for patient identification to build study cohorts for clinical research. Traditionally, diagnosis codes in the EHR, such International Classification of Diseases (ICD), are used to identify the target patients. However, the accuracy of this approach is dependent on the accuracy of ICD coding, with potential errors especially for tumor types that are frequent locations for metastases (which may contribute to mis-coding). In this study, we attempted to develop a Machine Learning (ML) based approach on EHR data to improve the accuracy of identification of patients with lung cancer. Methods: We used survey respondents in the Enhanced, EHR-facilitated Cancer Symptom Control (E2C2, NCT03892967) cluster-randomized trial at Mayo Clinic as our initial pan-cancer cohort. E2C2 includes adults receiving Medical Hematology/Oncology care for a solid or liquid tumor at Mayo Clinic. We collected cancer diagnoses from the individually abstracted Mayo Clinic Cancer Registry to annotate the cancer type for the patients. Lung cancer related ICD-9 (162.X) and ICD-10 (C34.X) codes were used to build a search query on the Mayo’s EHR to find target patients from the E2C2 cohort, and to investigate the ICD-based lung cancer patient identification performance. Diagnosis, radiation oncology treatment (CPT 77261 - 77799), and antineoplastic drug administration data were collected from EHR as variables. Logistic Regression (LR), Support vector machine (SVM), Random Forest (RF), and eXtreme Gradient Boosting (XGB) were selected to build models for lung cancer patient identification. 10-fold cross-validation was implemented to assess the models. Precision, Recall, F1 Score, and area under the curve (AUC) were selected to measure the performance. Results: We collected 13,893 patients with a specific cancer diagnosis, and 1,394 were identified as having lung cancer. The identification performance across different methods is shown. The ICD-based method only had 0.65 precision. It means we collected a lot of false positive cases (other cancer but no lung cancer patient), as we mentioned in the background. SVM gets the best precision results, but its recall and F1 score are not good enough. XGB shows the best F1 Score and AUC, which also means this method achieved the best and most balanced performance. Conclusions: In this study, we found that XGB-based methods achieved the best identification performance for lung cancer. In the future, we will investigate if this is also true for the identification of other cancer types. [Table: see text]

Patients with serious illnesses may experience existential and psychosocial distress contributing to their pain and suffering. Addressing existential distress is challenging and may require a multidisciplinary approach. Often, providers feel uncomfortable or ill equipped to care for patients suffering from this distress. In the sample case, the patient has a life-limiting disease and is concerned about his family forgetting him, experiencing loss of dignity and narrative foreclosure. Loss of dignity is sensing hopelessness and worthlessness and a loss of self-determination. Narrative foreclosure is the premature conviction that one's life story has effectively ended. Beneficial interventions include meaning-centered psychotherapy and dignity therapy (DT). Both have an underlying theme of attempting to reverse the narrative foreclosure for patients with serious illnesses and maintain a sense of meaning in life. In addition, patients can be referred to palliative care to enhance coping and decrease depressive symptoms. Dr. Harvey Chochinov has outlined a framework that clinicians can use to care for their patients in a compassionate manner to specifically combat meaninglessness. In DT, a generativity document is created for the patient and their loved ones as part of the treatment along with the opportunity to answer the dignity conserving question. Success of this route of intervention includes greater will to live, reductions in stress, and benefits perceived by family. This article aims to give a framework to treat patients with serious illnesses experiencing psychosocial and/or existential distress.

e24087 Background: Patients with advanced cancer and their caregivers experience a substantial amount of distress. Limited research suggests that mindfulness-based interventions may improve quality of life and reduce anxiety. The virtually delivered Resilient Living program consisted of online modules, a print journal, and a total of 4 virtual training sessions focused on techniques for managing stress and building resilience (mindful presence, uplifting emotions, reframing experiences through principles of gratitude, compassion, acceptance, meaning, and forgiveness). The current pilot study was performed to assess the feasibility of the virtual Resilient Living Program for patients with advanced cancer and their caregivers, as well as preliminary effects on anxiety and related outcomes. Methods: Eligible patients included those age ≥18 years with a diagnosis of advanced cancer with expected prognosis > 6 months. Feasibility was defined as consent of at least 25% of eligible patients and their caregivers. Adherence was defined as 75% of the enrolled participants completing at least 3 of the 4 Resilient Living sessions. The primary outcome measure was anxiety as measured by the GAD-7; others included stress (PSS), quality of life (LASA), sleep (ISI), resiliency (Resiliency Scale), and fatigue (PROMIS-Fatigue SF). Results: Seventy-two eligible patients were referred to the study, of these 33 patients enrolled (46% enrollment), 15 also had a caregiver enroll. Thirty participants completed at least 3 virtual sessions (63% adherence). Data was collected at baseline, week 5 (after 2 session), week 9 (after 4 sessions), and week 12 (1 month after completion) for patients and caregivers. There were statistically significant improvements in anxiety at weeks 5, 9 and 12 (i.e., p < 0.05). Other results are outlined in the table. Conclusions: Virtual participation in the Resilient Living Program is feasible and acceptable for patients with advanced cancer and their caregivers. Data from this pilot study suggest that the program may positivity impact anxiety, stress, sleep, quality of life and resiliency. A larger randomized prospective clinical trial is warranted to confirm these preliminary findings. Clinical trial information: NCT04480008. [Table: see text]

11016 Background: Stress Management and Resiliency Training (SMART) is a validated resilience training program designed to reduce stress, improve emotional resilience, and decrease burnout. The prevalence of burnout among practicing oncologists is as high as 40%, but unknown among oncology trainees. We implemented a virtual format of the SMART program to the Hematology/Oncology fellowship at Mayo Clinic to assess the feasibility of such a delivery, measure baseline rates of burnout in this group, and to investigate if a virtual method of delivery is as effective as in-person delivery as described in the literature. Methods: The SMART project was a mixed-methods, prospective, single arm clinical trial. Hematology/Oncology Fellows at Mayo Clinic were invited to participate. Four one-hour training sessions were conducted virtually. Fellows were given access to SMART online video modules and a book which supported the content covered during virtual training, a companion resilience mobile app, and a paperback mindfulness journal. Stress, burnout, and emotional resilience were measured at baseline and three months post-intervention using the Perceived Stress Scale (PSS), Maslach Burnout Inventory (MBI), and Connor-Davidson Resilience Scale (CD-RISC2). Changes in mean scores on the PSS, MBI, and CD-RISC2 were assessed using the Wilcoxon signed-rank test. Program feedback and feasibility data were obtained during a virtual focus group. Audio transcripts from the focus group were codified for thematic analysis and verified by intercoder triangulation. A 6-month assessment will be due in March 2022. Results: 26 of 50 fellows invited participated in our study. At baseline, 24% of participants had measurable burnout and 92% had moderate to high stress. At 3-months, the number of participants with moderate to high stress decreased to 71%, while rates of burnout remained unchanged. The PSS demonstrated a decrease in mean stress (-10.9%, p = 0.005), while the MBI demonstrated decreased emotional exhaustion (MBI-EE -6.01%, p = 0.04), an improved sense of personal achievement (MBI-PA 28.1%, p < 0.001), but slightly worse feelings of depersonalization (MBI-DP 16.46%, p = 0.05). The CD-RISC2 suggested no change in global emotional resilience (-0.71%, p = 0.82). Thematic analysis of the focus group data revealed that participants overwhelmingly found the program beneficial (83% of all responses), 20% indicated improved stress, and 15% indicated improved work performance. Conclusions: Oncology fellows in this study had lower rates of burnout compared to practicing oncologists. Virtual implementation of the SMART program is feasible and resulted in improvements in stress and prevented worsened burnout. Outcomes were comparable to previously published studies conducted in-person. Focus group participants found the training beneficial, reported lower stress, and improved work performance.

Abstract Background The symptom burden associated with cancer and its treatment can negatively affect patients’ quality of life and survival. Symptom-focused collaborative care model (CCM) interventions can improve outcomes, but only if patients engage with them. We assessed the receptivity of severely symptomatic oncology patients to a remote nurse-led CCM intervention. Methods In a pragmatic, cluster-randomized, stepped-wedge trial conducted as part of the National Cancer Institute IMPACT Consortium (E2C2, NCT03892967), patients receiving cancer care were asked to rate their sleep disturbance, pain, anxiety, emotional distress, fatigue, and limitations in physical function. Patients reporting at least 1 severe symptom (≥7/10) were offered phone consultation with a nurse symptom care manager (RN SCM). Initially, patients had to “opt-in” to receive a call, but the protocol was later modified so they had to “opt-out” if they did not want a call. We assessed the impact of opt-in vs opt-out framing and patient characteristics on receptiveness to RN SCM calls. All statistical tests were 2-sided. Results Of the 1204 symptom assessments (from 864 patients) on which at least 1 severe symptom was documented, 469 (39.0%) indicated receptivity to an RN SCM phone call. The opt-out period (odds ratio [OR] = 1.61, 95% confidence interval [CI] = 1.12 to 2.32, P = .01), receiving care at a tertiary care center (OR = 3.59, 95% CI = 2.18 to 5.91, P &lt; .001), and having severe pain (OR = 1.80, 95% CI = 1.24 to 2.62, P = .002) were associated with statistically significantly greater willingness to receive a call. Conclusions Many severely symptomatic patients were not receptive to an RN SCM phone call. Better understanding of reasons for refusal and strategies for improving patient receptivity are needed.

5554 Background: A better understanding regarding the burden of treatment side effects in patients with gynecological malignancies could help guide symptom interventions and oncologic therapy decision-making. We aim to inform understanding of symptom burden in epithelial ovarian cancer (EOC) by analyzing patient-reported symptom data from patients treated for this condition over a 16-month period. Methods: Patients receiving medical oncology care at Mayo Clinic Rochester and at Midwest Mayo Clinic Health System community sites have received symptom-focused surveys prior to each medical oncology visit since March 28, 2019 through the Enhanced Electronic Health Record Facilitated Cancer Symptom Control Study (E2C2). These surveys, administered either through the electronic medical record portal or on a clinic tablet prior to each oncology office visit, no more frequently than every 2 weeks, include six linear analogue scales measuring sleep disturbance, pain, anxiety, emotional distress, and fatigue (SPADE), as well as physical dysfunction on a scale of 0 (none) to 10 (as bad as you can imagine). Scores of 0-3 were considered mild symptoms, 4-6 moderate symptoms, and 7-10 severe symptoms. We collected survey results from March 28, 2019 to July 20, 2020 for patients with EOC and reviewed the number of surveys per patient in addition to the average symptom scores. Results: From March 2019 to July 2020, for patients with EOC, there were 2974 encounter-based surveys from 762 patients. The number of surveys completed by each patient ranged from 1-20. The following number of patients returned the correlating number of surveys: 1 survey:240 patients; 2 surveys:145; 3 surveys:79; 4 surveys:56; 5 surveys:58; 6 surveys:45; 7 surveys:38; 8 surveys:27; 9 surveys:22; ≥10 surveys:52. The average score from all surveys for each symptom was: 2.41 for sleep disturbance, 2.03 for pain, 2.32 for anxiety, 1.97 for emotional distress, 3.26 for fatigue, and 2.50 for physical dysfunction. Please see the table for the proportion of surveys that reported symptoms as mild, moderate, or severe. Conclusions: Fatigue and physical dysfunction were reported most frequently in patients with EOC, while emotional distress and pain were reported least frequently. 20% of surveys reported moderate to severe emotional distress, while 40% reported moderate to severe fatigue. A targeted approach to symptom management is needed for patients undergoing EOC evaluation and treatment. Our next steps in this analysis include an assessment of potential predictors of greater symptom burden (e.g., specific treatments, age, and other clinical and sociodemographic characteristics). Clinical trial information: NCT03892967. [Table: see text]

9075 Background: Chemotherapy-induced peripheral neuropathy (CIPN), a common dose-limiting side effect of chemotherapy, remains without known effective interventions. Preliminary data support that Scrambler therapy, a device which treats pain via non-invasive cutaneous electrostimulation, is beneficial for the treatment of CIPN. This pilot trial was performed to investigate the effect of Scrambler therapy for the treatment of CIPN. Methods: Eligible patients included those age ≥18 years, ECOG PS ≤2, life expectancy ≥3 months, with pain or CIPN symptoms of ≥1 month duration and tingling or pain ≥4/10 during the prior week. Patients were treated with Scrambler therapy to the affected area for up to 10 daily 30 minute sessions. Symptoms were monitored daily during therapy using a questionnaire to measure symptoms of neuropathy with a numerical analogue scale. Results: We report on the first 11 CIPN patients, enrolled between 7/18/2011 and 12/12/2011, 3 men and 8 women; mean age 57 years. Patients had history of exposure to various chemotherapeutic agents and the majority had symptoms >2 years. The table portrays data at baseline, at the end of the 10 planned days of therapy, and the percent changes from baseline to the end of treatment, regarding patient reported pain, tingling, and numbness over the preceding 24 hours. There were no adverse events. Persistent benefit out to 5 weeks was seen in some patients; maturing data will be available by May 2012. Descriptive summary statistics formed the basis of data analysis. Further patients are being entered on this trial. Conclusions: Scrambler therapy appears to be beneficial in the treatment of CIPN. A prospective placebo-controlled clinical trial should be performed to confirm these preliminary findings. [Table: see text]