Linear Analogue Self-assessment Research Articles

Learning environment and its relationship with quality of life and burn-out among undergraduate medical students in Pakistan: a cross-sectional study

ObjectiveThis study was conducted to determine the association between the learning environment, quality of life (QoL), and burn-out among students from selected public-sector and private-sector medical colleges in Lahore, Pakistan.DesignThis...

Music Therapy Intervention to Reduce Symptom Burden in Hospice Patients: A Descriptive Study.

Background: Music therapy (MT) offers benefits of improved symptom relief and quality of life at the end of life, but its impact on hospice patients and caregivers needs more research. Objective: To assess the impact of MT intervention on symptom burden and well-being of hospice patients and caregivers. Methods: A total of 18 hospice patients, selected based on scores ≥4 on the revised Edmonton Symptom Assessment System (ESAS-r) items on pain, depression, anxiety, or well-being, participated in MT sessions provided by a board-certified music therapist. Over a period of 2-3weeks, 3-4MT sessions were conducted for each. Patient Quality of life (QOL) was assessed using the Linear Analogue Self-Assessment (LASA). Depression and anxiety were measured with the Patient Health Questionnaire-4 (PHQ-4). For the 7 caregivers enrolled, stress levels were measured using the Pearlin role overload measure and LASA. Results: Patients reported a reduction in symptom severity and emotional distress and an increase in QOL. All patients endorsed satisfaction with music therapy, describing it as particularly beneficial for stress relief, relaxation, spiritual support, emotional support, and well-being. Scores on overall QOL and stress were worse for caregivers. Conclusion: This study provides evidence that MT reduces symptom burden and enhances the quality of life for hospice patients. Hospice patients and their caregivers endorsed satisfaction with MT. Given the benefits observed, integrating MT into hospice care regimens could potentially improve patient and caregiver outcomes. Larger studies should be conducted to better assess the impact of MT in this population.

NCOG-36. IMPACT OF COLLAGEN TILE BRACHYTHERAPY AS TREATMENT FOR RECURRENT GLIOBLASTOMAS ON FUNCTIONAL STATUS AND QUALITY OF LIFE

Abstract BACKGROUND Recurrent glioblastoma is an aggressive disease with dismal prognosis despite advances in standard therapy, making the maintenance of functional status and quality of life (QOL) in patients an important endpoint during treatment. Here, we report functional status (KPS) and QOL metrics (LASA and FACT-Br) at 6-months post-treatment for recurrent glioblastoma patients treated with maximal safe resection followed by intraoperative placement of collagen tile brachytherapy with Cesium-131 (Surgically Targeted Radiation Therapy or STaRT), a novel brachytherapy carrier. OBJECTIVE To assess the impact of STaRT on KPS and QOL among patients with recurrent glioblastoma (rGBM) at 6-months post-treatment. METHODS Patients were treated between 10/2020 and 05/2023 as part of a multi-institutional registry study (NCT#04427384). KPS was used to measure functional status. Linear Analog Self-Assessment (LASA) and Functional Assessment of Cancer Therapy – Brain (FACT-Br) were used to measure QOL. All assessments were collected at pre-surgery, and 1,3, and 6-months post-treatment. RESULTS 57 rGBM patients were treated on the Registry between 10/2020 and 05/2023. Of the 57 participants, 47 participants remain in the study, with 21 participants reaching the 6-month time point (5 exits, 5 deaths). Median age was 60 years (range 28-81). Methylguanine methyltransferase (MGMT) promoter was methylated in 17.5%, unmethylated in 38.5%, and unknown in 44%. Gross total resection was achieved in 72% of participants. Median KPS was 80% (range 40%-100%) at screening versus 70% (range 40%-90%) at 6 months post-treatment. Median LASA was 37 (range 8-50) at pre-surgery versus 34 (range 5-48) at 6-months post-treatment. Minimally important differences (MID) were noted between pre-surgery (136.9 ± 29.5) and 6-months post-treatment (112.5 ± 35.7) for the FACT-Br Total Score. CONCLUSION This interim data analysis supports further investigation of STaRT as a treatment for recurrent glioblastomas as a means of providing stable functional status and quality of life.

Music Therapy Intervention to Reduce Caregiver Distress at End of Life: A Feasibility Study.

Music therapy (MT) can relieve distressing end-of-life symptoms, but little is known regarding its effect on caregivers who are at risk for emotional distress as their loved ones approach death. Quality of life (Linear Analogue Self-Assessment), depressive and anxiety symptoms (Patient Health Questionnaire for Depression and Anxiety), and stress (Role Overload Measure) pre-MT, post-MT and at 6-month follow-up, as well as a satisfaction survey post-MT. Single MT session for 20-45 minutes OUTCOMES: 15/20 completed MT intervention, 14 also completed pre-MT and post-MT assessments, and 9 completed assessments at all 3 timepoints. Post-MT satisfaction survey (n=14) showed 100% of caregivers were very satisfied with MT and would recommend to others, and found MT very effective for emotional support (85.7%), stress relief (78.6%), spiritual support (71.4%), general feeling of wellness (71.4%), relaxation (69.2%), and pain relief (33.3%). Research on MT is feasible for caregivers of inpatient hospice patients. ClinicalTrials.gov Identifier: NCT03322228.

Baseline Quality of Life is a Strong and Independent Prognostic Factor for Overall Survival in Metastatic Colorectal Cancer.

Previous studies have established that higher baseline quality of life (QOL) scores are associated with improved survival in patients with metastatic colorectal cancer (mCRC). We examined the relationship between overall survival (OS) and baseline QOL. A total of 1 247 patients with mCRC participating in N9741 (comparing bolus 5-FU/LV, irinotecan [IFL] vs infusional 5-FU/leucovorin [LV]/oxaliplatin [FOLFOX] vs. irinotecan/oxaliplatin [IROX]) provided data at baseline on overall QOL using a single-item linear analogue self-assessment (LASA) 0-100 point scale. The association of OS according to clinically deficient (defined as CD-QOL, score 0-50) vs not clinically deficient (nCD-QOL, score 51-100) baseline QOL scores was tested. A multivariable analysis using Cox proportional hazards modeling was performed to adjust for the effects of multiple baseline factors. An exploratory analysis was performed evaluating OS according to baseline QOL status among patients who did or did not receive second-line therapy. Baseline QOL was a strong predictor of OS for the whole cohort (CD-QOL vs nCD-QOL: 11.2months vs 18.4months, P < .0001), and in each arm IFL 12.4 vs 15.1months, FOLFOX 11.1 months vs 20.6months, and IROX 8.9months vs 18.1months. Baseline QOL was associated with baseline performance status (PS) (P < .0001). After adjusting for PS and treatment arm, baseline QOL was still associated with OS (P = .017). Baseline QOL is an independent prognostic factor for OS in patients with mCRC. The demonstration that patient-assessed QOL and PS are independent prognostic indicators suggests that these assessments provide important complementary prognostic information.

Pilot/Phase II Trial of Hypofractionated Radiation Therapy to the Whole Breast Alone Before Breast Conserving Surgery

PurposeOur purpose was to report the results of a phase II trial of patients with breast cancer treated with hypofractionated whole breast radiation therapy (RT) before breast-conserving surgery (BCS). Methods and MaterialsBetween 2019 and 2020, patients with cT0-T2, N0, M0 breast cancer were enrolled. Patients were treated with hypofractionated whole breast RT, 25 Gy in 5 fractions, 4 to 8 weeks before BCS. Pathologic assessment was performed using the residual cancer burden (RCB). Toxicities were assessed according to Common Terminology Criteria for Adverse Events (version 4). Quality of life was assessed with Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, The Breast Cancer Treatment Outcome Scale, Linear Analogue Self-Assessment, and Patient-Reported Outcomes Measurement Information System. ResultsTwenty-two patients were enrolled. Median follow-up was 7.6 months (range, 0.2-16.8). Seven (32%) and 2 (9%) patients experienced grade 2+ or 3 toxicities, respectively. Overall quality of life Linear Analogue Self-Assessment and Patient-Reported Outcomes Measurement Information System did not change significantly from baseline (P = .21 and P = .72, respectively). There was no clinically significant change (≥1 point) in any of The Breast Cancer Treatment Outcome Scale domains. Only 1 (5%) patient experienced a clinical deterioration that corresponded to a “fair” outcome on the Harvard Cosmesis Scale. At pathologic evaluation, 14 (64%) patients had RCB-0 or RCB-I, including 3 (14%) patients with a pathologic complete response (RCB-0). Eight patients (36%) had RCB-II. No local or distant recurrences have been observed. ConclusionsExtremely hypofractionated whole breast RT before BCS is a feasible approach. There were low rates of toxicities and good cosmesis. Further investigation into this approach with RT before BCS is warranted.

Patient Reported Outcomes and Final Results of Phase 1 Evaluation of the Safety and Clinical Activity of Sapanisertib in Combination with Serabelisib and Paclitaxel in Patients with Advanced Ovarian, Endometrial, or Breast Cancer (044)

<b>Objectives:</b> To evaluate the safety, efficacy, and patient-reported outcomes of the combination of paclitaxel, sapanisertib, and serabelisib. <b>Methods:</b> This is an open-label cohort study of sapanisertib (TAK-228) and serabelisib (TAK-117) given on days 2-4, 9-11, 16-18, and 23-25 with paclitaxel on days 1, 8, and 15 of a 28-day cycle. A traditional 3+3 dose escalation design with a maximum of five dosing cohorts was used. All five cohorts plus an expansion cohort were presented. Patient-reported outcomes utilizing the Therapy-Related Symptom Checklist (TRSC) and Health-Related Quality of Life – Linear Analogue Self-Assessment (HRQOL-LASA) were also evaluated. <b>Results:</b> Enrollment has been completed, and the overall results are summarized in Table 1. Nineteen patients have been enrolled, a majority of which were heavily pretreated, with the average number of prior regimens exceeding four. Overall, the combination of the three drugs was well-tolerated, except by patients in cohort 5. One dose-limiting toxicity occurred in the last patient enrolled. About 503 adverse events have been reported to date, but only 45 (9%) grade 3 or 4 events. Results of the TRSC and HRQOL show that patients generally tolerated the therapy well and maintained or improved their quality of life while on therapy in cohorts 1-4. As expected, patients with higher symptom scores had a corresponding diminished quality of life. Three patients had a complete response (CR), four had a partial response (PR), and four patients had stable disease (SD). The overall response rate is currently 47% in 15 evaluable patients. The clinical benefit rate is 73%, and the progression-free survival currently stands at approximately 11 months. All patients received comprehensive genomic profiling, and seven patients had received prior everolimus or temsirolimus. <b>Conclusions:</b> Overall, the combination of sapanisertib, serabelisib, and paclitaxel was safe and well-tolerated throughout the first four cohorts. Preliminary efficacy results appear very promising, especially for patients with PI3K/AKT/mTOR pathway mutations. The positive effects of the combination were routinely seen in the lowest dosing cohorts, and clinical benefit was even seen in patients who had previously failed everolimus or temsirolimus. There were few serious adverse events, and most side effects were managed with routine supportive care interventions. Data from the HRQOL and TRSC confirm that this combination was well tolerated and support further evaluation of this therapy.

A prospective, randomized trial of patient-reported outcome measures to drive management decisions in hematology and oncology

BackgroundClinicians have limited time during patient encounters which can result in patients' concerns not being addressed. This study's objective was to test whether an electronic patient-reported outcome quality of life tool (PROQOL) in which patients identify their primary concern during clinic visits improves cancer patient quality of life (QOL). Patients and methodsThis single center non-blinded prospective clinical trial randomized patients (2:1) to PROQOL versus usual care (UC). Two patient cohorts were enrolled: those with hematologic malignancies (multiple myeloma [MM] or light chain amyloidosis [AL]) and solid tumors (head and neck [H/N] or gynecologic [GYN] malignancies). Primary endpoint was patient-reported QOL at 12 months measured by a single-item Linear Analog Self-Assessment. Value to patients and impact on clinician workflow was measured using a “was it worth it” survey. The study was powered to detect a 0.5 standard deviation difference between groups. ResultsOverall 383 patients were enrolled, 171 with MM, 62 AL, 113 GYN, and 37 H/N between July 2016 and April 2018, with 12-month follow-up. There were 171 (44.6%) male patients and median age was 62 years (range 31–87). The most often selected concern was physical health (30.9%), and second was cancer diagnosis and treatment (29.1%). Mean QOL was 7.12 for PROQOL and 6.98 for UC (0–10 scale) at 12 months, with no between-group difference overall (p = 0.56) or within hematologic or solid tumor cohorts, respectively. Among patients, 74% thought the PROQOL tool was worthwhile, 86% would choose PROQOL again, and 81% would recommend it to others. Among clinicians, 95% responded that PROQOL was worthwhile and did not think that PROQOL negatively impacted their workflow. ConclusionsAlthough we did not demonstrate a QOL difference between PROQOL and UC groups; the PROQOL tool held considerable value in identifying patients' main concerns over time and was worthwhile for patients and clinicians.

Effects of patient-reported outcome assessment order.

In clinical trials and clinical practice, patient-reported outcomes are almost always assessed using multiple patient-reported outcome measures at the same time. This raises concerns about whether patient responses are affected by the order in which the patient-reported outcome measures are administered. This questionnaire-based study of order effects included adult cancer patients from five cancer centers. Patients were randomly assigned to complete questionnaires via paper booklets, interactive voice response system, or tablet web survey. Linear Analogue Self-Assessment, Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, and Patient-Reported Outcomes Measurement Information System assessment tools were each used to measure general health, physical function, social function, emotional distress/anxiety, emotional distress/depression, fatigue, sleep, and pain. The order in which the three tools, and domains within tools, were presented to patients was randomized. Rates of missing data, scale scores, and Cronbach's alpha coefficients were compared by the order in which they were assessed. Analyses included Cochran-Armitage trend tests and mixed models adjusted for performance score, age, sex, cancer type, and curative intent. A total of 1830 patients provided baseline patient-reported outcome assessments. There were no significant trends in rates of missing values by whether a scale was assessed earlier or later. The largest order effect for scale scores was due to a large mean score at one assessment time point. The largest difference in Cronbach's alpha between the versions for the Patient-Reported Outcomes Measurement Information System scales was 0.106. The well-being of a cancer patient has many different aspects such as pain, fatigue, depression, and anxiety. These are assessed using a variety of surveys often collected at the same time. This study shows that the order in which the different aspects are collected from the patient is not important.

Patient-reported outcomes version of the common terminology criteria for adverse events and quality-of-life linear analogue self-assessment in breast cancer patients receiving radiation therapy: single-institution prospective registry

Purpose/objectivesWe sought to investigate the impact of patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) on overall quality-of-life (QOL) employing linear analogue self-assessment (LASA) in breast cancer (BC) patients undergoing radiation therapy (RT).Materials/methodsAll patients treated with RT for BC with curative intent from 2015 to 2019 at our institution were included. Breast specific PRO-CTCAE and overall QOL LASA questionnaires were administered at baseline, end-of-treatment, 3, 6, 12 months, and then annually. Minimal clinically important difference in overall QOL was a 10-point change in LASA. Hypofractionation was any treatment > 2 Gy per fraction. Mixed models for repeated measures were used to determine the association of PRO-CTCAE and overall QOL LASA.ResultsThree hundred thirty-one (331) patients with a median follow-up of 3.1 years (range 0.4–4.9) were included. Average overall QOL LASA scores were 78.5 at baseline, 79.8 at end-of-treatment, 79.8 at 3 months, 77.1 at 6 months, 79.4 at 12 months, and 79.7 at 24 months. On univariate analysis, patients reporting a grade ≥ 3 PRO-CTCAE had, on average, a 10.4-point reduction in overall LASA QOL (p < 0.0001). On multivariate analysis, not being treated with hypofractionation and higher BMI were predictive for worse overall LASA QOL with a 10-point reduction in LASA for patients reporting a grade ≥ 3 PRO-CTCAE (p < 0.0001).ConclusionsPatients reporting a grade ≥ 3 PRO-CTCAE experienced statistically significant and clinically meaningful deterioration in overall QOL LASA. Hypofractionation improved QOL while higher BMI predicted for worse QOL. PRO-CTCAE should be integrated into future clinical trials.

MC1635: Randomized Phase III Trial of Hypofractionated Radiotherapy to the Whole Breast After Breast Conserving Surgery

Hypofractionated radiation therapy (RT) for localized breast cancer improves patient convenience and reduces treatment cost. Here, we report the early results of MC1635 randomized trial.Between 04/04/2018 and 02/11/2020, patients with localized breast cancer (T1-T3, N0-N1, M0) managed with breast conserving surgery (BCS) were enrolled. Patients were randomized to receive whole breast RT with moderate hypofractionation to 40 Gy in 15 fractions (Arm A) or extreme hypofractionation to 25 Gy in 5 fractions (Arm B). An optional concurrent integrated boost to 48 Gy on Arm A or 30 Gy on Arm B was allowed. All patients were treated daily (Monday-Friday). Analysis of early toxicity (< 3 months), late toxicity (> 3 months), quality of life (QOL), cosmesis, and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) were done. QOL was assessed with patient-reported outcomes measurement information system (PROMIS), overall Linear Analogue Self-Assessment (LASA), and The Breast Cancer Treatment Outcome Scale (BCTOS). Deterioration of cosmesis was defined as going from excellent/good to fair/poor or from fair to poor according to the Harvard Cosmesis Scale.One hundred seven patients were randomized to either Arm A (n = 54) or Arm B (n = 53). Median follow-up was 20 months. Patient characteristics included: IDC 55%, ILC 20%, mixed 7%, DCIS 16%, other 3%; grade 1 or 2 72%, grade 3 28%; triple negative 9%, ER/PR+ 84%, and Her2+ 7%. Treatment characteristics included: sentinel lymph node biopsy 68%, axillary lymph node dissection 32%; spot scanned proton therapy 50%, 3D conformal x-rays 50%; and an integrated boost 21%. No significant differences in any characteristics were noted between the two arms. No grade 3 toxicities occurred on either arm. Grade 2 toxicities were seen in 7.4% of Arm A and 7.5% of Arm B. This primarily consisted of radiation dermatitis (6 patients) with 1 patient with fibrosis and 1 patient with lymphedema. Deterioration in cosmesis ≥ 3 months after RT was seen in 1.6% of Arm A and 1.7% of Arm B (P = 0.4). The average Harvard Cosmesis score was similar between arms at all timepoints. QOL was similar between arms, as well. Patient-reported radiation skin burns of 'moderate to severe' as assessed by PRO-CTCAE were more commonly reported in Arm A (58.7%) vs Arm B (27.9%) (odds ratio 3.7, CI 1.5-8.9; P = 0.004). Patient satisfaction with treatment was very high with more than 98% of patients in both arms saying that they would do RT again. No cancer recurrences or deaths have been seen in either arm.Our early analysis of our randomized study suggests that extreme hypofractionation using 25 Gy in 5 fractions is well-tolerated and as safe as moderate hypofractionation. Patient-reported radiation skin burns were 3.7 times less likely with 25 Gy in 5 fractions. Further follow-up is warranted.

MC1732: Pilot/Phase II Trial of Hypofractionated Radiotherapy to the Whole Breast Alone Before Breast Conserving Surgery

To report the results of our phase II trial of breast cancer patients treated with hypofractionated whole breast radiation therapy (RT) prior to breast conserving surgery (BCS).Between 2019 and 2020, patients with cT0-T2, N0, M0 breast cancer were enrolled. Patients were treated with hypofractionated whole breast RT, 25 Gy in 5 fractions, 4-8 weeks prior to BCS. RT was delivered with proton beam therapy or photons and no RT boost or regional nodal irradiation was allowed. Pathologic assessment was performed using the Residual Cancer Burden (RCB). Toxicities were assessed according to Common Terminology Criteria for Adverse Events (CTCAE, Version 4). Quality of life (QOL) was assessed with Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE), The Breast Cancer Treatment Outcome Scale (BCTOS), Linear Analogue Self-Assessment (LASA), and patient-reported outcomes measurement information system (PROMIS). Deterioration of cosmesis was defined as going from excellent/good to fair/poor or from fair to poor according to the Harvard Cosmesis Scale.Twenty-two patients were enrolled. Median follow-up was 7.1 months (range, 0.2-16.8). Median age at RT was 64.1 years (range, 44.3-76.7). Tumor characteristics included: IDC 68%, ILC 14%, DCIS 5%, other 14%; grade 1 55%, grade 2 36%, 5%; ER+HER2- 95%, ER+HER2+ 5%; right-sided 68%, left-sided 32%. The DCIS were all ER+. Pre-treatment tumor size include Tis 5% and T1 95%. Median time from RT to BCS was 8 weeks. Seven (32%) patients and 3 (14%) patients experienced grade 2+ or 3 toxicity, respectively. Overall QOL LASA and PROMIS did not change significantly from baseline (P = 0.21 and P = 0.72, respectively). There was no clinically significant change (≥1 point) in any of the BCTOS domains. Patient satisfaction with treatment was high with over 90% of patients saying they would do RT again. Only 1 (5%) patient experienced a clinical deterioration that corresponded to a 'Fair' outcome on the Harvard Cosmesis Scale. At pathologic evaluation, 14 (64%) patients had RCB-0 or RCB-1 including 3 (14%) patients with a pathologic complete response (RCB-0). No local or distant recurrences have been observed.Hypofractionated whole breast RT prior to BCS yielded excellent pathologic responses. There were low rates of toxicities and good cosmesis. Further investigation into this approach with RT before BCS is warranted.

202 - Music Therapy Intervention to Reduce Caregiver Distress at End of Life: A Feasibility Study

ContextMusic therapy is frequently provided to patients at the end of life, and studies have shown a benefit in relief of symptoms and a positive impact on quality of life (QoL), but little is known regarding the effect of music therapy (MT) on caregivers. Caregivers are at risk for anxiety, emotional distress and experience anticipatory grief as the patient nears death. Caregivers are present with patients and may also benefit from MT.ObjectiveTo assess the impact of MT on caregivers for hospice patients and determine the feasibility of research in this population.MethodsTwenty caregivers of patients hospitalized for general inpatient hospice care were enrolled. MT was provided by a board-certified music therapist, and sessions included pre-MT assessment, 20-45 minutes of MT, and post-MT assessment. Caregiver stress was measured with the Pearlin Role Overload Measure (ROM), QoL was measured with the Linear Analogue Self-Assessment (LASA), and depression and anxiety were measured with the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). These three measures were taken pre-MT, post-MT and 6 months post-MT. Caregivers were also asked to complete a Music Therapy Program Survey post-MT.ResultsThe MT intervention was completed for 15/20 caregivers (75%). Of those who did not complete MT, 2 withdrew prior, 1 was not available, 1 patient passed during the MT session, and 1 patient died prior to MT. 14 caregivers completed pre-MT and post-MT assessments, and 9 caregivers completed assessments at all 3 timepoints. The MT Program Survey (post-MT assessment, n=14) showed 100% of caregivers were very satisfied with MT and would recommend to others, 78% found MT effective for stress relief, 69% for relaxation, 71% for spiritual support, 86% for emotional support, and 71% for feeling of wellness.ConclusionResearch on MT is feasible for acute hospice care caregivers with a majority of caregivers consenting to research and about half completing surveys pre-MT, post-MT, and 6-months post-MT (9/20). Future larger studies should be conducted to better assess the impact of MT on caregivers.

Duration Matters: Impact of Time from Diagnosis on Symptoms in Patients with Hematologic Malignancies

Background: Patients with hematologic malignancies experience physical, emotional, financial and social burdens of disease. There are multiple stages of a cancer diagnosis patients experience over time. In order to provide complete and individualized cancer care to patients with hematologic malignancies, it is important to understand how patient experience evolves over time. Here we describe the impact of time from diagnosis on the common symptoms of stress and fatigue and the impact on quality of life in hematologic malignancies.Methods: Surveys were distributed to individuals with a past or present cancer diagnosis at the Mayo Clinic “Living with and Surviving Cancer” patient symposium in January 2016. Survey items included demographic data, symptom understanding and management strategies, the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) and the Linear Analog Self Assessment (LASA). Participants were categorized by time from diagnosis (TFD) as chronic diagnosis (CD) TFD >3 years and recent diagnosis (RD) defined as TFD ≤3 years.Results:Demographics : 60 patients with hematologic malignancies completed the survey, 29 patients with CD defined as TFD >3 years, and 31 with RD defined as TFD≤3 years. The mean age for all participants was 67 years ([SD] 10.3) with a slight female predominance (N=34, 57%). Age and gender distribution did not differ between TFD >3 and ≤3 years (P= 0.99 and P=0.07, respectively). Hematologic diagnoses did not differ by TFD (plasma cell dyscrasia 48% CD vs 29% RD, P=0.13; lymphoma/chronic lymphocytic leukemia 45% CD vs 48% RD, P=0.78; acute leukemia/myelodysplastic syndrome 10% CD vs 16% RD, P=0.51; myeloproliferative neoplasm 3% CD vs 6%, RD P=0.59). Patients with RD were more likely to report additional solid malignancy diagnosis (breast cancer 20% RD vs 0% CD, P=0.1; non-melanoma skin cancer 13% RD vs 0% CD P=0.04). Active chemotherapy treatment did not differ based on TFD (31% CD vs 36% RD, P=0.7).Stress : Patients with RD reported a significantly lower stress level on the LASA (Table 1). RD patients were more likely to report a higher understanding of stress management (23% vs 0% CD, P=0.01). Both groups reported highest level of stress directly following diagnosis (75% RD vs 67% CD, P=0.5).Both groups reported similar stress management strategies (exercise 65%, P=0.93; spirituality 53%, P=0.8; anxiety medications 33%, P=0.85; meeting a psychiatrist/psychologist 16%, P=0.41; yoga 8%, P=0.58) with the exception that patients with RD were more likely to utilize “other” stress management strategies (35.5% vs 10% CD, P=0.02) including meditation, mindfulness, and information gathering.Fatigue: Patients with RD reported significantly less fatigue on the QLQ-C30 (Table 1). Understanding fatigue management was not impacted by TFD (P=0.25). Both groups reported highest fatigue during treatment (57% RD vs 62% CD, P=0.94). Both groups reported similar utilization of fatigue management strategies (exercise 63%, P=0.73; spirituality 43%, P=0.18; anxiety medications 20%, P=0.43; meeting a psychiatrist/psychologist 8%, P=0.58, and “other” 21% CD, P=0.86). CD patients were more likely to experience significant fatigue most days of the month (54% vs 22% RD, P=0.04).Quality of Life : Patients with RD reported improved emotional functioning and improved global health status on the QLQ-C30 (Table 1).Conclusion: Patients with hematologic malignancies experience significant symptoms, including stress and fatigue, at various stages of their condition. Our exploratory study indicates patients with a longer duration of cancer diagnosis (>3 years) experience a higher level of stress, less knowledge to manage stress, and more fatigue compared to those with a more recent diagnosis despite similar diagnoses and active chemotherapy use. This suggests that patients with a longer duration of cancer diagnosis are at increased risk for symptoms and decreased quality of life. Health care providers should consider this population to be particularly at risk and focus supportive care interventions to address the accumulation of cancer consequences. [Display omitted] DisclosuresGowin:Incyte: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Mikhael:sanofi-aventis: Research Funding; Celgene Corp: Research Funding; Abbvie: Research Funding. Khera:Novartis: Consultancy. Mesa:Novartis Pharmaceuticals Corporation: Consultancy; Celgene Corporation: Research Funding; CTI BioPharma Corp.: Research Funding; Gilead Sciences, Inc.: Research Funding; Incyte Corporation: Research Funding; Ariad: Consultancy; Promedico: Research Funding; Galena Biopharma, Inc.: Consultancy.

Association between Patient-Reported Outcomes and Physical Activity Measured on the Apple Watch in Patients with Hematological Malignancies

Background:Patient-reported outcomes (PRO's) are important measures in patients with malignancies, but may be burdensome to complete. Wearable activity monitors provide objective, continuous activity data which may correlate with PRO's. The aims of this study were: 1) develop electronic technology to measure PRO's; 2) examine associations between PRO's and wearable technology data; and 3) develop emoji PRO scales.Methods:Patients were recruited from Mayo Clinic hematology and oncology practices. Eligibility included: adult patients with a diagnosis of lymphoma, multiple myeloma, brain cancer, pancreatic cancer, breast cancer, and ovarian cancer within the past 5 years, life expectancy of >6 months, and own an iPhone version 5.0 or greater. All patients were provided with an Apple Watch and downloaded the study app onto the iPhone and watch at enrollment. Baseline PRO data was collected on the iPhone, including the PROMIS physical function, fatigue, sleep, social/role function short forms; single item linear analog self-assessment (LASA) of QOL, fatigue, and physical function; and emoji scales. Two emoji scales were developed for this study: a mood scale and a scale for physical, emotional, and overall QOL. Participants were instructed to wear the watch at least 8 hours/day. Activity levels were analyzed using the square root of the average daily values in order to minimize the effects of outliers. Univariate associations between PROs and activity levels were assessed using Spearman correlations. Multivariate associations were assessed using stepwise linear regression models. This analysis is reporting the baseline activity and PRO results of the lymphoma and myeloma patients recruited to date in this ongoing study.Results:From 2/2017-8/2017, 89 patients with lymphoma and 26 with multiple myeloma were recruited. 52% were male and median age was 55 years (range 21-79). The median time since diagnosis was 8.4 months (range 0-60); 74% were on active therapy, 16% were in observation post-treatment, and 10% had not been treated. Patients had an ECOG PS of 0 (47%), 1 (32%), 2 (12%), 3 (7%), and 4 (3%). The majority (64%) of patients were overweight or obese. All patients were “extremely” confident filling out forms, 99% had used a computer in the past 12 months, and 26% had ever used a smart watch.During week 1 of the study, patients wore the watch for an average of 9.3 hours per day, did 3760 mean steps per day (SD 3417), exercised 8.3 minutes/day (SD 11.8), were sedentary 224.9 minutes/day (SD 154.2), and burned 115.8 kcal/day (SD 111.5). Mean heart rate was 82 beats per minute (SD 8.2).There were significant correlations between PRO's and activity data; the strongest correlation was between steps per day and PROMIS physical function (Spearman correlation 0.33, p=0.0005). The association between steps per day and PROMIS physical function remained significant after adjusting for age and performance score (p=0.0076, figure 1). There were no variables significantly associated with active energy, flights, workout minutes, cycling distance, or heart rate.Emoji responses were significantly associated with PROs; the Spearman correlations between the emoji and LASAs were -0.84 for fatigue, 0.68 for physical well-being, 0.72 for emotional well-being, and 0.77 for overall QOL (all p<0.0001).Out of the 15 patients that have completed the study, all of them reported they would recommend filling out forms using the smart phones and watches, collecting data using emoji scales, and were very willing to complete future surveys using the watch compared to 87% by iPad, 33% by computer, 20% by paper, 20% by live telephone interview, and 0% by automated telephone interview.Conclusions:Apple Watch activity data is significantly associated with PRO's in patients with lymphoma and myeloma, and emoji scales are a promising tool to collect PRO's. Collecting data utilizing wearable technology and smart phones is feasible and preferred by patients. Further studies will analyze the ability of activity data to predict longitudinal changes in PRO's. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Usage of Patient-Centered Outcomes in the Management of Anemia: A Systematic Review

Background: Patient-centered outcomes (PCOs) evaluate the physical, social, and psychological impact of disease on patient wellbeing. Patient-centred tools are critical for improving physician-patient communication, managing chronic disease, and optimizing novel therapies. Anemia is a diagnosis that affects all ages, sexes, and ethnicities, and is a frequent consequence of both acute and chronic conditions. Treatments for anemia, including iron supplementation, erythropoietin-stimulating agents, and blood transfusion may be associated with improvements in hematological parameters, but the impact of treatments for anemia on quality of life remains poorly understood. Objective: To critically assess published studies that have measured PCOs to investigate the effects of anemia management on quality of life and patient wellbeing. Methods: We searched PUBMED, EMBASE, PsychInfo, and CINAHL for relevant studies published from 1980 to January 2017. Eligibility criteria included full-text observational studies, case series (N >10), and randomized-controlled trials (RCTs) published in English. We included studies with anemic patients undergoing any intervention for treatment of anemia that reported hemoglobin levels and PCOs before and after anemia intervention. Risk of bias was assessed in interventional and observational cohort studies using the Cochrane Risk of Bias Tool and Newcastle Ottawa Scale, respectively. Study methodological and patient characteristics, PCOs, and additional outcomes will be qualitatively synthesized, and meta-analysis will be performed for PCOs. Subgroup analysis will be performed by disease category, and by type of intervention for anemia. The efficacy of PCO tools will be assessed, and this analysis will be performed separately for studies where the anemia intervention improved hemoglobin levels versus studies where hemoglobin levels did not increase following treatment. Finally, the prevalence of individual PCO tool use will be reported, both overall and for each disease category. The PROSPERO registration number for this systematic review is CRD42017056290. Results: Of the 2230 articles found during database and reference list searching, 406 were read in full text and 111 met all inclusion criteria. Preliminary analysis found that 45.9% (51/111) eligible articles pertained to anemia in oncology, 8.1% (9/111) to malignant hematological disorders, 15.3% (17/111) to benign hematological disorders, 12.6% (14/111) to anemia in renal disease, 4.5% (5/111) to anemia in cardiovascular disease, 3.6% (4/111) to anemia in gastrointestinal disease, and 9.9% (11/111) to other anemia diagnoses. Furthermore, 53.2% (59/111) articles utilized more than one PCO tool to assess quality of life. While the majority of studies used various combinations of PCO tools, we found that 20.7% (23/111) incorporated the Short Form Health Survey (SF-36) tool, 52.3% (58/111) incorporated the Functional Assessment of Cancer Therapy (FACT-G) tool or a FACT subscale tool (i.e. FACT-Anemia and/or FACT-Fatigue), 32.4% (36/111) incorporated the Linear Analog Self-Assessment (LASA) tool, and 5.4% (6/111) incorporated the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQC30) tool. Final descriptive analysis, meta-analysis, and disease-specific subgroup analysis results are forthcoming. Conclusions: From our preliminary results, oncology studies comprised over half of all included studies. The most commonly utilized PCO tool was the FACT tool or a FACT tool subscale. Further analyses will focus on the efficacy of these PCO tools in evaluating quality of life based on type of anemia intervention and disease category. DisclosuresStaibano:American Society of Hematology: Research Funding.

A phase III multicenter randomized controlled trial of postsurgical stereotactic radiotherapy versus surgically targeted radiation therapy (STaRT) for the treatment of large (&gt;2.5cm) newly diagnosed brain metastases: Trial in progress.

TPS2067 Background: Resection (R) followed by single or multi-fraction stereotactic radiosurgery (SRT) of brain metastases lowers resection bed recurrence compared to R alone. Nevertheless, for larger (&gt;2.5cm) brain metastasis, 12-month recurrence rates after R+SRT can exceed 20–30%. Aiming to improve outcomes, a permanently implanted collagen tile brachytherapy device (GammaTile or GT, GT Medical Technologies, Tempe, AZ) utilizing Cs-131 seeds embedded within a bioresorbable collagen tile was developed and is described as Surgically Targeted Radiation Therapy (STaRT) to distinguish it from external beam radiation therapy. It is hypothesized that immediate adjuvant radiotherapy (RT) and/or RT dose intensification could improve outcomes. The device is FDA-cleared for this indication and early commercial use is demonstrating favorable safety and efficacy outcomes. STaRT allows rapid dose delivery of radiation therapy directly to the tumor bed with predictable dosimetry immediately at the time of resection, and an intense but localized radiation treatment, which may confer a reduced risk for radiation necrosis compared to other therapies. The device is easily placed with minimal additional operative time and limited staff radiation exposure. It is hypothesized that R+ STaRT will increase the surgical bed recurrence-free survival, while reducing the impact on functional and neurocognitive status compared to R+SRT. Methods: Multicenter, randomized, comparison trial of patients with resectable, previously untreated “index” brain metastases measuring ≥2.5–5 cm, and 0–3 other tumors, will be preoperatively randomized 1:1 to undergo either R+ SRT or R+STaRT to the index lesion; unresected tumors in both groups will receive SRT. Planned sample size is 180 from 13 sites. Enrollment will open in Q1. Primary endpoint is surgical bed-recurrence free survival. Secondary endpoints include overall survival, quality of life (Functional Assessment of Cancer Therapy-Brain, Linear Analog Self-Assessment), neurocognition (Hopkins Verbal Learning Test, Trail Making Tests, Controlled Oral Word Association), functional status (Karnofsky Performance Scale, Barthel-ADL), and adverse events. Follow-up will be at 1,3,6,9, and 12 months, then every 6 months through 24 months. This will be the first randomized trial comparing R+SRT versus R+STaRT delivered by Cs-131 sources in permanently implanted resorbable collagen tile carriers. Primary and secondary outcome measures will be captured to elucidate the potential risks and benefits of these two differing post-operative RT delivery methods in the setting of newly diagnosed metastatic brain tumors. Clinical trial information: NCT04365374.

POS-287 TREATMENT BURDEN AND HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH NON–DIALYSIS-DEPENDENT ANAEMIA OF CHRONIC KIDNEY DISEASE RECEIVING ERYTHROPOIESIS-STIMULATING AGENTS: A SYSTEMATIC LITERATURE REVIEW

Anaemia of chronic kidney disease (CKD) is associated with morbidity, poor health-related quality of life (HRQoL) and increased mortality. Standard of care includes erythropoiesis-stimulating agents (ESAs), but they are not widely used in non–dialysis-dependent (NDD) patients, due to safety concerns. A broader assessment of patient-centric outcomes is needed. We performed a systematic literature review of treatments for anaemia of CKD in NDD patients. We report the treatment burden, including safety, and HRQoL in patients with NDD anaemia of CKD from ESA trials. We searched electronic databases and other sources to identify randomised controlled trials (phase 2+) for ESAs in the treatment of anaemia of CKD in adults. The search was not limited to outcomes or countries. Other criteria were English publications between database inception and 23 January 2020 (search date). We conducted risk of bias and descriptive assessments of study and patient characteristics, treatment burden and HRQoL. Overall, 4,024 abstracts were screened, and 325 publications were reviewed; 38 ESA NDD-CKD trials of 12,594 randomised patients with anaemia were included. Although 27 trials (71%) had a risk of bias based on quality appraisal, these were included in the descriptive analysis. Overall, 6/38 (16%) trials were phase 3, 24 (63%) were open-label, and 9 (24%) were double-blind. ESAs, such as darbepoetin alfa (DPO) and epoetin alfa, were investigated and often compared with an active comparator, such as other ESAs or iron. Four trials compared high/low haemoglobin (Hb) targets in both ESA treatment arms. Rescue therapy included iron use (45%; 17 trials) and RBC transfusion (3%; 1 trial). Across trials, the mean age was 46.0–84.4 years; baseline Hb range was 8.2–12.2 g/dL. Treatment burden (e.g. discontinuations and adverse events) was evaluated in the safety populations (n=13,082); the burden of treatment administration was not observed. Hypertension was reported frequently as an adverse event across treatment arms (up to 37% of patients) in 18 trials. Treatment discontinuation was reported in 27 trials; common reasons included adverse events, dialysis, treatment failure or other illnesses. The most commonly used HRQoL instruments were Short Form-36 (SF-36; 9 trials), EQ-5D (2 trials), Linear Analogue Self-Assessment (2 trials) and the KDQoL Questionnaire (2 trials). SF-36 scores were statistically significant for ESA vs. placebo as early as 8 weeks (1 trial) and through 1 year (1 trial), though domain-specific results were inconsistent across trials. HRQoL outcomes, such as changes in physical functioning and fatigue scores, were reported in 14 trials; 2 trials evaluated exercise capacity. HRQoL was generally maintained or showed clinically relevant improvements across instruments, particularly for patients receiving ESAs vs. other comparators. Hypertension, as an adverse event was common across treatment arms. Patient-reported treatment burden and HRQoL outcomes were not measured consistently. Questionnaire use was low; SF-36 was mostly frequently used, which is not specific to kidney disease/anemia of CKD. More consideration and consistency of patient-centric outcomes, including complementary evidence from observational studies, may help better understand the holistic impact of ESA treatment on clinical management.

Wellbeing of Frontline Health Care Workers After the First SARS-CoV-2 Pandemic Surge at a Neuroscience Centre: A Cross-sectional Survey

Background:The coronavirus disease 2019 (COVID-19) pandemic has affected people of all ages, races, and socioeconomic groups, and placed extraordinary stress on health care workers (HCWs). We measured the prevalence of burnout and assessed wellbeing and quality of life (QoL) in HCWs at a single UK neuroscience center after the first pandemic surge.Methods:A 38-item electronic questionnaire was disseminated through local team email lists between May 22 and June 7, 2020, to HCWs in a university neurosciences center. Burnout was measured using the single-item Emotional Exhaustion and Depersonalization scales, and wellbeing and QoL assessed using the Linear Analogue Self-Assessment Scale and the EuroQol-5 Dimension instrument.Results:The response rate was 57.4% (n=234); 58.2% of respondents were nurses, 69.4% were women and 40.1% were aged 25 to 34 years. Overall, 21.4% of respondents reported burnout assessed by the Emotional Exhaustion scale; burnout was higher for nurses (23.5%) and allied health care professionals (22.5%) compared with doctors (16.4%). HCWs from ethnic minority groups reported a higher rate of burnout (24.5%) compared with white HCWs (15.0%). There were no differences in reported wellbeing or QoL between professional groups, or HCW age, sex, or race. Nurses (36.8%) and staff from ethnic minority groups (34.6%) were more fearful for their health than others.Conclusions:Our findings highlight the prevalence of HCW burnout after the first surge of the pandemic, with an increased risk of burnout among nurses and staff from ethnic minority groups. Both nursing and staff from ethnic minority groups were also more fearful for their health. With ongoing pandemic surges, the impact on HCW wellbeing should be continuously assessed to ensure that local strategies to support staff wellbeing are diverse and inclusive.

PULSE: A randomized phase II open label study of panitumumab rechallenge versus standard therapy after progression on anti-EGFR therapy in patients with RAS wild-type metastatic colorectal cancer (mCRC).

TPS143 Background: Patients with KRAS and NRAS ( RAS) wild-type mCRC benefit from the epidermal growth factor receptor (EGFR) monoclonal antibodies (Abs) panitumumab and cetuximab, but nearly all patients experience resistance. Blood-based profiling of cell free DNA (cfDNA) can identify genomic alterations that drive acquired EGFR Ab resistance. After discontinuation of anti-EGFR Abs, acquired genomic alterations decay over time to undetectable levels. Some studies have suggested clinical benefit from EGFR Ab rechallenge, but there is limited evidence that EGFR Ab rechallenge improves survival compared to standard of care (SOC) therapies. We hypothesize that cfDNA profiling will identify patients appropriate for panitumumab rechallenge, and that these molecularly selected patients will have improved survival compared to current SOC therapies. Methods: This is a randomized phase II, open label study designed to compare the overall survival (OS) of panitumumab rechallenge versus SOC (investigator choice TAS-102 or regorafenib). Secondary objectives include comparisons of progression free survival, objective response rate, clinical benefit rate, and quality of life as measured by the linear analogue self-assessment (LASA) questionnaire. Eligible patients have radiographically measurable KRAS, NRAS, and BRAF codon 600 wild-type mCRC based on tumor tissue testing, and must have experienced progression or intolerance to treatment with a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF Ab, and an anti-PD-1 Ab if the tumor has mismatch repair deficiency or is MSI-H. Progression after at least 4 months treatment with an anti-EGFR Ab is required. All patients must be enrolled in the COLOMATE cfDNA screening protocol (NCT03765736) and meet molecular eligibility based on Guardant360 cfDNA profiling (absence of amplification of ERBB2, KRAS, NRAS, and MET; absence of mutations of BRAF, EGFR, ERBB2, KRAS, NRAS, and MET [mutant allele frequency &gt; 0.5%]). Greater than 90 days must have elapsed between the most recent treatment with an anti-EGFR Ab and cfDNA profiling. Dosing for all study drugs is according to clinical SOC. 120 patients will be randomized 1:1 to panitumumab rechallenge or SOC. With 83 OS events, this study will have 80% power to detect an improvement in median OS from 6.5 to 10 months (HR=0.65; 1-sided α= 0.15). This study began enrollment in 6/2020. Recruitment is ongoing at 16 sites in the Academic and Community Cancer Research United (ACCRU) network (ACCRU-GI-1623). Clinical trial information: NCT03992456.