Post-Discharge Follow-up with Quality of Life Assessment in Covid 19 Patients Admitted during the Covid 19 Pandemic

Intro: Patients affected with COVID-19 have been reported to have persistent symptoms even months after the acute episode, most commonly fatigue, breathlessness, and symptoms of anxiety and depression. These residual symptoms have been shown to compromise the quality of life and lead to significant impairment in both the mental and physical health of these patients. Method(s): A prospective observational cohort study was carried out and patients were followed for a month after discharge. Residual symptoms were noted, quality of life (QoL) assessment was done using EQ-5D-5L, and anxiety/depression was evaluated using WHO-SRQ 20 scores. Appropriate statistical tests were applied to compare improvement in QoL and residual symptoms between first and the last visit. Finding(s): A total of 110 patients were included. Mean age of the patients was 53.7 (SD+/- 13) years. Most common symptoms at 1st follow up were shortness of breath (66%) and fatigue (65%) which reduced in frequency on the last visit to (43%) and (46%) respectively. Significant improvement was seen in SpO2 levels recorded at both visits (p=0.000). An overall improvement in QoL was seen (p=0.000). WHO-SRQ 20 score above 8 was noted in 20% patients and mean score was 5.91. On further categorization into mild, moderate, severe and critical disease on admission, patients showed improvement in symptoms at four weeks irrespective of categories. For QoL assessment, mean utility score showed improvement in all disease categories on the 2nd visit except for patients with mild disease on admission. Conclusion(s): Our study showed a significant improvement in residual symptoms and overall quality of life when followed over a period of time in majority of the patients. Symptoms of anxiety and depression were also not frequent. However, our findings emphasize the need of a multidisciplinary approach towards rehabilitation of COVID-19 patients for earlier improvement in their quality of life.Copyright © 2023

Clinical and quality of life assessment in patients with latex allergy during COVID-19 pandemic: Possible protective role of continuous latex immunotherapy

Background: During Covid-19 pandemic, the massive use of Personal Protective Equipment could provoke severe adverse reactions in latex allergy patients and could negatively affect their quality of life. Method(s): The observational single-centre present study was carried out on 67 adult subjects with a latex allergy diagnosis followed by Allergy Unit of Fondazione Policlinico Universitario A. Gemelli IRCCS of Rome. All data were collected from January 2020 to December 2020. All patients underwent to a survey focused on their clinical and psychological conditions during Covid-19 pandemic. For the evaluation of the degree of well-being, we used SF-36 questionnaire (Short-Form 36-Item Health Survey). The aim of our study is: (a) to evaluate the incidence of allergic reactions in patients with latex allergy during the SARS-CoV- 2 pandemic;(b) to evaluate the protective role of continuous latex ITS during this period;(c) to evaluate quality of life of natural rubber latex allergy (NRLA) patients during the pandemic. Result(s): 67 patients (9 males and 58 females, mean age of 45.9 +/- 11.4 years) suffered from latex allergy were included in the present study. We recorded among our patients 13 cases (34.2%) of urticarial/ angioedema (U/A), 9 cases (23.6%) of respiratory symptoms (RS;dyspnoea, shortness of breath, wheezing) and 7 cases (18.4%) of anaphylaxis. In patients undergone continuous ITS, we observed less cases of U/A (p < 0.001), RS (p < 0.001), anaphylaxis (p = 0.003), hospitalizations (p = 0.014) and a lower therapy administration. We compared the results of SF-36 questionnaire in patients undergone continuous and not continuous latex ITS with a significance differences score between these two groups. Conclusion(s): The pandemic challenged the capacity of healthcare systems to provide adequate management of NRLA patients and in this context, we performed a survey to monitor their health status. During the pandemic, the risk of latex exposure was significant increased considering the possibility of direct skin contact, airborne exposure, contamination of food and medical evaluations. Our study is the first that investigated the clinical and quality of life effects of Covid-19 pandemia in NRLA patients demonstrating the importance of SLIT adherence also in this complex period. (Table Presented).

Assessing the impact of an urgent dental care centre on the oral health-related quality of life of patients during the COVID-19 pandemic

Introduction: An urgent dental care centre (UDCC) was set up at Queen Mary's Hospital in Sidcup, in response to the COVID-19 pandemic. Alongside the reporting of clinical outcomes, it is important to determine the success of a service from a patient's perspective. The aim of this study was to ascertain patient reported outcome measures (PROMs) and patient reported experienced measures (PREMs) of our service. Method(s): The Oral Health Impact Profile 14 (OHIP-14) tool was used to assess the Oral Health-Related Quality of Life (OHRQoL) of patients, and completed before and after attending our UDCC for treatment. Patients were also asked to complete a patient satisfaction questionnaire. Result(s): 146 patients were recruited for our study, with 95 patients completing the OHIP-14 questionnaires pre- and post intervention at our UDCC and 136 patients completing a patient satisfaction questionnaire. A statistically significant reduction in OHIP score when comparing pre- and post-intervention was found across all OHIP-14 domains. The mean positive response rate (strongly agree or agree) for the patient satisfaction questionnaire was 97.1%. Conclusion(s): A significant improvement in OHRQoL was found after treatment at our UDCC, with the majority of patients reporting a positive experience. We conclude that PROMs and PREMs are vital tools to assess service efficacy, help with the planning of service provision and should remain at the forefront even during a crisis such as the COVID-19 pandemic.Copyright © 2021

A Study To Assess The Quality Of Life Among Elderly In Relation To Covid-19 Pandemic In Selected Area Of Sonipat, Haryana State

The first case of the corona virus illness (COVID-19) was discovered in Wuhan, China, in December 2019, and India discovered its first case on January 30, 2020. As it expanded slowly over the world, several nations began to experience its effects. Because of its severity, the World Health Organization declared it a new pandemic on March 11, 2020. Although while all age groups were affected by Covid-19, some were shown to be particularly susceptible in terms of morbidity and death. Immune system deterioration is a common side effect of aging. Thus it only seems sense that older people are more impacted by COVID-19. According to the CDC (Centre for Disease Control), 8 out of every 10 fatalities in the US are caused by those 65 years of age or older. These results made it very evident that older people are sufficiently concerned about Covid-19 infection. Coupled with the limits imposed by the government as a result of the epidemic, several health concerns among the elderly population also surfaced. Physical health suffered from restricted access to medical services already in place, while elderly people's mentality suffered from the frightening environment brought on by the epidemic. Older people's social lives were also negatively impacted by lockup or Covid-19 restrictions. So, there is a strong assumption by researcher that the quality of life of elderly need to be assessed in present pandemic situation. Methodology: In this current study researcher adopted a quantitative approach with descriptive research design to investigate the research problem. The elderly was identified as a population whereas the elderlies of selected areas of Sonipat, Haryana identified as samples. Based on power analysis method researcher identified the sample size as 500 elderlies, which were recruited based on eligibility criteria of sample identification. RThe non-probability convenient sampling strategy was chosen by the researcher to assemble the study's sample. For the purpose of gathering pertinent information from study participants, research instruments were devised. These tools were divided into two categories: socio-demographic factors, which collected baseline data on participants;and quality of life assessment measures, which were used to gauge research participants' quality of life. These tools were developed and verified by specialists, and a pilot study was used to evaluate their viability and dependability. Elderly people were given these instruments, and comprehensive data were gathered. The collected data were tabulated and analysed in SPSS version-23. Result(s): findings in regard to quality of life among elderly in relation to covid-19 have mentioned. It reflected that majority of elderlies 79.4% (397) were scored at poor level of quality of life whereas remaining 20.6% (103) found at average level of quality of life. The mean and standard deviation of quality of life among elderlies during Covid-19 was 89.45+/-19.74. In Section-IV the significant association in between quality of life among elderly with selected demographic variables were stated and it revealed that gender (4.266), education (10.483), family monthly income (8.662), working status of elderlies (4.065), and suffering with other disease (8.924) were significantly associated at 0.05 level of significance. Based on analysed data the research hypothesis H1 were accepted by investigator. Conclusion(s): Based on findings of the study, researcher concluded that majority of elderlies are facing poor level of quality of life in relation with Covid-19 pandemic and none of study participant found with good level of quality of life, which shows that current pandemic deeply influenced the life of elder population. Thus, the researcher advises that a process intervention be implemented to improve the aged population's quality of life during this difficult period of the Covid-19 epidemic.Copyright © 2022 Wolters Kluwer Medknow Publications. All rights reserved.

Feasibility, Safety and Efficacy of a Combined Supervised Physical Exercise and Nutritional Program in a Selected Population of Luminal Metastatic Breast Cancer Patients: Oncare01 Pilot Study

Background: Supervised exercise programs (SEP) have demonstrated an improvement in quality of life (QoL), cardiovascular health, treatment tolerance and disease outcomes in early breast cancer patients. In metastatic breast cancer (MBC), previous data suggest SEP are safe but no impact on QoL and a low adherence to programs were shown. These studies included a heterogenous population in terms of type of treatments received, numbers of previous lines or comorbidities. From our perspective, MBC profile that could benefit most from SEP needs to be explored. Thus, we conducted a pilot study to assess adherence, safety and impact on QoL of a combined SEP and nutritional program (NP) in a selected population of MBC of patients treated with cyclin-dependent kinase 4/6 inhibitors (iCDK 4/6). Method(s): This is a prospective, single center, single arm pilot study. SEP consisted in a 12-week intervention with twice a week in-person resistance exercise session. Patients also completed weekly aerobic exercise goals in self-managed sessions monitored with activity trackers. SEP was conducted by registered Physical Activity and Sports Science instructors that followed American College of Sports Medicine guidelines. In addition, participants had an initial nutritional assessment and personalized counselling by a qualified nutritionist. Adherence to treatment, biological variables and QoL assessments (FACIT-Fatigue and QLQ-C30 questionnaires) were collected at baseline (B) and week-12 (w12). Primary endpoint was global adherence (>=70% of attended sessions relative to scheduled sessions). Secondary endpoints included safety, changes in biological variables and QoL. Paired samples t-tests (Wilcoxon) were used to assess biological changes and QoL. Result(s): Patients (n=26) were recruited from October 2020 to November 2021. Median age was 47,5 years (45-55);84,6% of patients were ECOG 0. 42,3% of patients were receiving Abemaciclib;34,6% Ribociclib and 23,1% Palbociclib in first (73,1%) or second (26,9%) line treatment. Patients had bone (69,2%);visceral metastasis (57,7%) or both (30,8%). 2 patients did not start the intervention and additional 7 patients discontinued the program prematurely, the majority of them due to COVID-related concerns. Considering all patients who at least attended one session, global adherence was 66% (39-77,5%) and 45,8% of patients achieved an adherence of >= 70%. Patients reported an improvement in QoL [B global QLQ-C30 66,6 (50-75), w12 75 (66,6-83,3);p 0,0121] and fatigue [B FACIT-Fatigue 37 (30-44), w12 42 (38-48);p 0,0017]. Sit-to-stand repetitions in 30-second period also improved [(B 15 (12-17), 19 (15-23);p 0,0002]. Same benefits were seen in patients with adherence >= 70%. No statistically significant changes were seen in body fat or muscular composition and handgrip scores. Importantly, no safety issues related to study intervention were reported. Conclusion(s): Even though the study was conducted during COVID-19 pandemic, global adherence was 66%. For the first time in MBC, SEP and NP combined program demonstrated to be safe and improved QoL in patients with first or second line MBC treated with iCDK4/6. Further research is needed to identify strategies that improve QoL in MBC.

Effect of a 12 Week Virtual Supervised Exercise Program on Cardiorespiratory Fitness in Breast Cancer Patients Undergoing Chemotherapy: Results from the STRENGTH Trial

Background: Chemotherapy (CTX) for breast cancer (BC) can have a detrimental effect on cardiorespiratory fitness (CRF), as measured by VO2max. This decline may be attenuated by physical activity, which can also reduce mortality risk and improve quality of life (QoL) for patients (pts) with BC. During the COVID-19 pandemic, many have pivoted to home-based exercise routines, which have been shown to be safe and feasible for pts with BC receiving CTX. We conducted the STRENGTH Trial to evaluate the effect of a 12-week virtual supervised exercise program in BC pts receiving CTX on CRF. Method(s): This is a single-center, prospective, single-arm study designed to evaluate the effect of a 12-week virtual supervised exercise training program on CRF in BC pts receiving CTX. Participants aged >=18 years with stage I-IV BC who were planned to receive at least 12 weeks of CTX of investigator's choice were eligible for inclusion. Participants were asked to complete a total of 150 minutes (min) of moderate intensity physical activity/week, as a combination of a 45 min weekly virtual personal training session and workout classes streamed from the Peloton Digital platform (i.e. walking, running, cardio, yoga, strength training, and cycling). The primary endpoint was the distance walked on a Six-Minute Walk Test (6MWT), an accepted surrogate marker for VO2max, at the start and completion of the program. Secondary endpoints included assessment of QoL using the Functional Assessment of Cancer Therapy - General (FACT-G) and symptom assessment using the MD Anderson Symptom Inventory (MDASI) questionnaires at the beginning, middle and end of the study. Exploratory endpoints included treatment adherence, toxicities, completion and response. Result(s): 33 participants signed consent for the clinical trial and 2 withdrew voluntarily prior to beginning the program. 5 participants discontinued prematurely due to a diagnosis of COVID-19 (N=3) and pulmonary embolism (N=2) and were not included in the primary endpoint. One participant remains on study at this time. Median age 49 yrs;range 33-68. Mean BMI 29.55;range 18.1-46.5. 13 HR+/HER2-, 7 HR-/HER2-, 11 HER2+. 14 (45%) pts had Stage I, 11 (35%) pts had Stage 2, 5 (16%) pts had Stage 3, 1 (3%) pt had Stage 4. 23 pts (70%) received either an anthracycline or HER2-based therapy. 19 pts (61%) received neoadjuvant CTX on study, 11 pts (35%) received adjuvant CTX and 1 pt (3%) received treatment in metastatic setting. The average number of exercise min per week per participant was 123.2 min (95% CI, 104.1-142.2), with a relative dose intensity of 82%. In the pts that completed the study thus far (N=25), there was no statistically significant difference between the distance walked during the 6MWT at the start and end of the study (median difference= -10m, range: -129-150m, p= 0.67). There was no statistically significant difference in the FACT-G score at the start and end of the study (median difference= -1.0, range -17.83- 30.0, p=0.54). Pts scored higher on the MDASI (median difference= 0.33, range -1.55-4.62, p=0.04) at the end of the exercise program compared to the beginning. There were no new or unexpected treatment toxicities observed. Conclusion(s): Pts who participated in a 12-week virtual supervised exercise program during CTX for BC did not experience a statistically significant difference in the distance walked during the 6MWT between the beginning and end of the exercise program. Exercise may attenuate the decline in cardiorespiratory function that has historically been observed with CTX for BC. Some pts were not able to adhere to the recommended 150 min of exercise/week suggesting a potential need for modified exercise targets for pts with BC undergoing CTX. This study is limited by a small sample size and larger, randomized clinical trials are needed to further evaluate optimal exercise recommendations for patients with BC undergoing CTX in order to maintain and potentially, even improve, cardiorespiratory function.

Effect of Social Media Addiction on Aggression and Overall Quality Of Life on Undergraduate Students

This research examined the effect of social media addiction on aggression and overall quality of life on undergraduate students at Lovely Professional University, Phagwara, Punjab. In the study, survey method was used to collect data. A sample of 50 students were selected for this study. Quality of Life Scale by John Flanagan, Internet Addiction Test by Kimberly S. Young, and The Aggression Scale by Pamela Orpinas and Ralph Frankowski (2001) were administered for data collection. SPSS tool has been used for data analysis. Results indicated that there is a positive and significant connection between social media addiction, aggression, and quality of life. It has also been found that Covid-19 has leaded to increased social media addiction, and therefore, more grave consequences. Copyright © 2022, Anka Publishers. All rights reserved.

PRACTICE OF SELF-MEDICATION AND QUALITY OF LIFE ASSESSMENT AMONG HEALTHCARE WORKERS OF A TERTIARY HOSPITAL IN ASSAM DURING COVID-19 PANDEMIC

Objectives: The aims of this study were to collect sociodemographic, clinical data regarding practice of self-medication and to assess quality of life in healthcare workers involved taking care of COVID-19 patients. Methods: The study population consisted of 104 healthcare workers from Gauhati Medical College and Hospital directly involved in management and control of COVID-19 Pandemic. It was a cross-sectional observational study using non-probability sampling. Data were collected in a questionnaire developed by the investigators which included age, sex, and occupation, COVID-19 such as symptoms, medicines used, contraction and confirmation of COVID-19 positive, and self-medication when COVID positive, symptomatic relief, and adverse effects and usefulness of self-medication. The data for mental health were obtained in a questionnaire based on the Professional Quality of Life Scale (Compassion Satisfaction and Compassion Fatigue Version 5) with responses rated on a five-point Likert scale. Results: The study consisted of 104 participants. Males were n=42 (40%) and females were n=62 (60%). Doctors n=20 (19%), Laboratory Technicians n=22 (21%), Nurses n=44 (42%), Pharmacists n=13 (13%), Ward boys n=3 (3%), and Ward girls n=2 (2%) took part. Eighty-four (97.7%) respondents took paracetamol, 39 (45.3%) took cough syrup, 30 (34.9%) used nasal decongestants, 25 (29.1%) utilized throat gargle, 24 (27.9%) used azithromycin, 22 (25.6%) used cefixime, 13 (15.1%) took amoxyclav, 27 (31.4%) took ORS, 3 (3.5%) took Doxycycline, 4 (4.8%) used Ivermectin, 1 (1.2%) took Dexamethasone, and 1 (1.2%) used Multivitamin. About 68% (n=51) of COVID Positive respondents self-medicated with Azithromycin, 24% (n=18) with Ivermectin, 41.3% (n=31) with Doxycycline, 20% (n=15) with Dexamethasone, and 4% (n=3) with Levocetrizine and Paracetamol. The Mental Health Assessment Scores were obtained as the sum total of scores of answers to the 30 questions provided per respondent. About 7% (n=7) respondents with total score between 60 and 69, 12% (n=13) from 70 to 79, 29% (n=30) from 80 to 89, 22% (n=23) from 90 to 99, 16% (n=17) from 100 to 109, 13% (n=13) from 110 to 119, and 1% (n=1) between 120 and 129. This indicates that some participants had mild burnout, most had moderate burnout, and a few had severe burnout. Conclusion: Self-medication practices common among healthcare workers, increased during the COVID-19 Pandemic which must be appropriately managed to stay away from the ill effects. Providing adequate mental health resources and education to the affected health workers will motivate them increasing their productivity during the pandemic.

ASSESSMENT OF QUALITY OF LIFE AND EFFECTS IN RECOVERED AND VACCINATED COVID19 POPULATION: A CROSS-SECTIONAL OBSERVATIONAL STUDY Original Article

Objective: The main objective of this study was to assess the QOL (quality of life) and effects on the recovered and vaccinated COVID-19study population. Methods: A cross-sectional observational study was carried out for six months among residential areas and selected individuals regardless of country. Demographic details and responses were collected through phone calls and also using google form questionnaires. Results: A total of 264 subjects were enrolled in this study. In the selected study of recovered patients, it was found that females (mean score 21.9) experience high effects compared to males (mean score 39.6) since a low mean score means higher post-effects. In the evaluation of postvaccination effects of the selected study population, it was found that males and females experience different levels of post-vaccination effects in which females(mean score 19.5) experience high effects comparatively to males (mean score 21.9). The result of the quality of life for both recovered patients and the vaccinated population infers that the younger age group was found to experience a high quality of life than the older age group who were>65 y of age. Conclusion: The study concludes that the elderly population of>65 y of age and females based on gender were likely to suffer from post-COVID-19 effects and post-vaccination effects. It can also be concluded that the younger age group has a healthy standard of living compared to the age group>65 y.

Vision-Specific Quality of Life in Patients with Post-Acute Sequelae of COVID-19 (PASC)

Objective: We sought to describe post-acute symptoms of COVID-19 (PASC)-related visual symptoms in a cohort of non-hospitalized individuals presenting to our outpatient neurology practices and undergoing vision-specific quality of life assessments. Background: Infection with SARS-CoV-2 (COVID-19) involves multiple systems, including those for vision. People with post-acute sequelae of COVID-19 (PASC) have reported many neurological symptoms such as brain fog, memory difficulties, and headache, as well as vision related complaints. Design/Methods: Participants completed standardized and well-validated vision-specific quality of life questionnaires, including the 25-Item National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) and the 10-Item Neuro-Ophthalmic Supplement to the NEI-VFQ-25 (NOS). Patient scores were compared to those of disease-free controls within the same age groups. Results: Among 50 participants reporting persistent COVID-related symptoms more than 6 weeks after acute illness, the average age was 49.3 ± 14.6 years;33/50 (65%) were female. Symptoms reported by patients were mostly general and not visual. However, vision-specific quality of life scores were significantly lower than values for normal healthy controls with no history of neurological or ophthalmological disease (p<0.0001 for both the NEI-VFQ-25 and NOS composite scores, two-sample t-tests). Mean NEI-VFQ-25 composite score was 89.5 ± 12.7 compared to 98.2 ± 2.1 for healthy controls. Mean NOS score was 82.7 ± 16.0 compared to 96.5 ± 5.2 for controls. Conclusions: People with post-acute sequelae of COVID-19 (PASC) in a neurology outpatient practice, even among those without visual symptoms that bring them to medical attention, report persistent visual quality of life impairment. These data support the inclusion of vision-specific outcome measures and symptom scales in studies of PASC, and confirm that COVID-19 infection may impair visual function.

Physical and psychological reconditioning in long covid syndrome patients: results of a structured physical exercise program

Background: Long Covid Syndrome (LCS) is used to describe signs and symptoms that continue or develop after acute COVID-19 infection. Natural history and treatments of this syndrome is still poorly understood. In literature there is currently a lack of data on the real effectiveness of a multidisciplinary rehabilitation program based on structured physical exercise (SPE) in these patients. Purpose: To evaluate safety, effectiveness and feasibility of a structured individualized rehabilitation program in improving physical and psychological parameters in patients with LCS. Methods: Twenty-eight patients with LCS (19 males, mean age 57 years) underwent an accurate medical screening process, body composition evaluation, cardiopulmonary exercise test (CPET), muscular strength assessment, quality of life (QoL), psychological assessment and counselling, before and after a 12-sessions SPE program. Results: At baseline, all LCS patients showed severe impairments in physical performance, QoL and psychological parameters. No adverse effects and dropouts were observed during training session. After the rehabilitation program, significant improvement in CPET parameters, upper and lower limb muscular strength, perceived physical and mental health, body composition, depression and anxiety and Covid residual symptoms was observed. Conclusions: The present study confirms severe impairment of patients with LCS and suggest that a multidisciplinary rehabilitation program based on SPE could promote their physical and psychological recovery.

Mountain Hiking vs. Forest Therapy: A Study Protocol of Novel Types of Nature-Based Intervention.

INTRODUCTION: The global rise of urbanization has much triggered scientific interest in how nature impacts on human health. Natural environments, such as alpine landscapes, forests, or urban green spaces, are potential high-impact health resources. While there is a growing body of evidence to reveal a positive influence of these natural environments on human health and well-being, further investigations guided by rigorous evidence-based medical research are very much needed. OBJECTIVE: The present study protocol aims at testing research methodologies in the context of a prospective clinical trial on nature-based interventions. This shall improve the standards of medical research in human-nature interactions. METHODS: The ANKER Study investigates the influence of two novel types of nature-based therapy-mountain hiking and forest therapy-on physiological, psychological, and immunological parameters of couples with a sedentary lifestyle. Two intervention groups were formed and spent a seven-day holiday in Algund, Italy. The "forest therapy group" participated in daily guided low-power nature connection activities. The "hiking group", by contrast, joined in a daily moderate hiking program. Health-related quality of life and relationship quality are defined as primary outcomes. Secondary outcomes include nature connection, balance, cardio-respiratory fitness, fractional exhaled nitric oxide, body composition and skin hydration. Furthermore, a new approach to measure health-related quality of life is validated. The so-called "intercultural quality of life" comic assesses the health-related quality of life with a digitally animated comic-based tool.

Durvalumab in frail and older patients with stage iv non-small cell lung cancer: The randomized phase ii duration trial

Introduction: Checkpoint inhibitors have recently been established as first-line treatment for metastatic NSCLC. Notably, a phenomenon known as immunosenescence, i.e. the progressive remodeling of the immune system with aging, as well as the inflammatory status, may interfere with the activity of PD-1/PD-L1 inhibitors. Although frail and older patients represent a major fraction of non-small cell lung cancer (NSCLC) patients in routine clinical practice, this population is still underrepresented in most clinical trials. Thus, clinical evidence about tolerability and efficacy of these novel agents in the elder and frail population is urgently required. Methods/Design: DURATION (NCT03345810) is a prospective, open label, treatment stratified, randomized, multicenter phase II study. The protocol foresaw the enrollment of 200 patients diagnosed with stage IV NSCLC ≥70 years old and/or with Charlson-Comorbidity Index > 1 and/ or with a performance status ECOG > 1. Patients were stratified according to Cancer and Age Research Group (CARG) score in 'fit' and 'less fit'. Patients were then randomized 1:1 to receive either CT or two cycles of CT followed by two cycles of durvalumab and durvalumab maintenance. Details are shown in figure 1. The primary endpoint is the rate of treatment-related grade III/IV adverse events. Secondary endpoints are progression-free survival, response rate and overall survival and quality of life assessment. The trial is accompanied by a biomaterial repository to explore potential biomarkers. Results: The last patient was enrolled in January 2021. Forty-nine, 48, 51, and 52 patients were allocated to arm A, arm B, arm C, and arm D, respectively. Currently, 145 patients have completed the study, 13 patients are under treatment (12 in total in durvalumab-maintenance arms and 1 in the CT arm), while 42 are in follow-up. Conclusions: Inspite of the COVID-19 pandemic, the DURATION trial successfully completed the planned enrollment of 200 patients, underlying the urgent need for evidence of efficacy and tolerability of immunotherapy in the challenging population of frail and elderly patients.

Randomized Study of Digital Life Coaching during Autologous Stem Cell Transplantation

BACKGROUND: Autologous stem cell transplantation (ASCT) for multiple myeloma (MM) entails sudden life changes including acute symptom burden, changes in physical function, and shifting caregiver dynamics. Several studies have shown that anxiety, insomnia, and distress rise in the initial weeks following ASCT before slowly recovering. Long-term consequences of these acute exacerbations include persistent quality of life (QOL) impairments (El-Jawahri 2016), post-traumatic stress disorder (Griffith 2020), and the usage of potentially inappropriate medications (PIMs) for symptom management (Banerjee 2021). We have recently completed a pilot study of digital life coaching (DLC), whereby life coaches work with patients via phone calls and text messages to provide longitudinal support, education, and accountability to meet wellbeing-related goals. Our pilot study of 15 patients demonstrated the feasibility of DLC during this period, with bidirectional patient-coach engagement occurring every 5-7 days even during index hospitalizations for ASCT (Banerjee 2021). Based on these positive results, we have now launched a randomized Phase 2 study of DLC versus usual care among patients with MM undergoing ASCT. STUDY DESIGN: Our study is registered at clinicaltrials.gov as NCT04589286. We plan to enroll 60 adult patients with MM undergoing first ASCT at our institution. Inclusion criteria include English language proficiency and ownership of a personal cellphone. However, neither smartphones nor specific mobile apps are required for study participation. All patients, including those in the control arm, receive brief wellness-related tips with each request for PRO data as outlined below. As shown in the Figure, patients in the DLC arm are paired with a trained life coach beginning at Day -10 before ASCT. Coaches use structured frameworks to assist patients longitudinally with identifying and accomplishing wellbeing-related goals. Specific coaching topics can vary from week to week and are set by each patient. In addition to weekly coach-led phone calls, patients are encouraged to maintain bidirectional communication via phone/text/email as often as desired. Patients in the control arm do not receive access to DLC. Our primary endpoint is the total usage of sedative-class PIMs - including lorazepam, temazepam, zolpidem, and other similar medications - prescribed for anxiety or insomnia during each of 4 four-week study subperiods identified in the Figure. Secondary endpoints include patient-reported outcome (PRO) assessments of QOL (PROMIS Global Health), distress (NCCN Distress Thermometer), and insomnia (PROMIS Sleep Disturbances 4A). PRO assessments are collected exclusively using automated REDCap emails every 1-2 weeks as shown in the Figure. PROGRESS TO DATE: As of the data cutoff (7/31/21), 19 patients have enrolled onto our study and 5 have completed all follow-up. The median age of enrolled patients is 62 (range: 31-77), with 26% of patients aged 70 or older. As shown in our pilot study (Banerjee 2021), PRO collection via automated REDCap emails is feasible. Specifically, of 93 email-based requests for PRO assessments as of the data cutoff, 92 (99%) have been completed. Analyses of PRO assessment responses and PIM usage will be conducted after study completion. DISCUSSION: Improving patient wellbeing during the acute peri-ASCT period is an unmet need in multiple myeloma. Published supportive strategies during this time include music therapy (Bates 2017), acupuncture (Deng 2018), palliative care (El-Jawahri 2017), and programmed hospital room lighting (Valdimarsdottir 2018). DLC may offer unique advantages given its easy accessibility and unified patient-facing interface across hospital/clinic/home transitions. These strengths may be particularly relevant in light of the COVID-19 pandemic, where home-based follow-up after ASCT has become more common. That being said, broadening the accessibility of DLC to include patients with limited English proficiency or patients without personal cell phones are important priorities for fu ure studies. In summary, our randomized Phase 2 study of DLC versus usual care is ongoing. If shown to reduce PIM prescription rates while improving wellbeing-related PRO trajectories longitudinally, DLC may become a standard of care for patients with hematologic malignancies undergoing ASCT. [Formula presented] Disclosures: Banerjee: Pack Health: Research Funding;SparkCures: Consultancy;Sanofi: Consultancy. Knoche: Amgen: Honoraria. Brassil: Abbvie: Research Funding;Astellas: Research Funding;BMS: Research Funding;Daiichi Sankyo: Research Funding;Genentech: Research Funding;GSK: Research Funding;Sanofi: Research Funding;Pack Health: Current Employment. Jackson: Pack Health: Current Employment. Patel: Pack Health: Current Employment. Lo: Oncopeptides: Consultancy;EUSA Pharma: Consultancy. Chung: Caelum: Research Funding. Wong: Amgen: Consultancy;Genentech: Research Funding;Fortis: Research Funding;Janssen: Research Funding;GloxoSmithKlein: Research Funding;Dren Biosciences: Consultancy;Caelum: Research Funding;BMS: Research Funding;Sanofi: Membership on an entity's Board of Directors or advisory committees. Wolf: Adaptive Biotechnologies: Consultancy;Teneobio: Consultancy;Sanofi: Consultancy;Amgen: Consultancy. Martin: Oncopeptides: Consultancy;Sanofi: Research Funding;Amgen: Research Funding;Janssen: Research Funding;GlaxoSmithKline: Consultancy. Shah: Bluebird Bio: Research Funding;GSK: Consultancy;Janssen: Research Funding;Indapta Therapeutics: Consultancy;BMS/Celgene: Research Funding;CareDx: Consultancy;CSL Behring: Consultancy;Kite: Consultancy;Nektar: Research Funding;Karyopharm: Consultancy;Amgen: Consultancy;Oncopeptides: Consultancy;Poseida: Research Funding;Precision Biosciences: Research Funding;Sanofi: Consultancy;Sutro Biopharma: Research Funding;Teneobio: Research Funding.

Global Waldenström's Macroglobulinemia Patient-Derived Data Registry, Whimsical, Highlights Real-World Treatment Outcomes and COVID-19 Data

Introduction: WhiMSICAL (Waldenström's Macroglobulinemia Study Involving CArt-wheeL) is the first global Waldenström's Macroglobulinemia (WM) registry capturing patient-derived data to complement scarce clinical trials data in this rare cancer (Tohidi-Esfahani et al, Am J Hematol 2021). The registry was interrogated to identify real-world first line treatment outcomes, quality of life (QoL) and coronavirus disease 2019 (COVID-19) data. Methods: The registry captures data through www.cart-wheel.org, an online rare cancer database, utilizing a tailored questionnaire developed by clinician and patient investigators. WM patients complete consent online, then enter symptom, pathology, treatment, QoL (EORTC QLQ-C30) and COVID-19 data, and can return to update their data on an ongoing basis. Recruitment is driven by social media messaging by the International Waldenström's Macroglobulinemia Foundation investigators. Time to next treatment (TTNT) was assessed from start of first therapy to start of second therapy. Patients without a documented second therapy were censored at the time of last edit to their account. COVID-19 questions included testing, disease severity, vaccination and impact on WM management. Results: As of July 2021, 558 patients from 20 countries have participated in the registry, predominantly from USA (50%), Australia (22%) and the UK (9%). Median age at diagnosis was 61 years (range 24-83) with male predominance (61%). 371 patients documented first-line therapies, with a total of 54 unique therapeutic combinations listed. The seven most common therapies were: bendamustine rituximab (BR, n=94), rituximab monotherapy (Rit., n=52), dexamethasone rituximab cyclophosphamide (DRC, n=33), ibrutinib (n=25), bortezomib dexamethasone rituximab (n=15), rituximab cyclophosphamide vincristine prednisolone (n=14) and chlorambucil (n=10). Comparison of TTNT was limited to the four most common first-line therapies: BR, Rit., DRC, with zanubrutinib (n=5) and ibrutinib plus rituximab (n=2) adding to the first line Bruton tyrosine Kinase inhibitor (BTKi) cohort (n=32). Median ages for the BR, BTKi, DRC and Rit. cohorts were 65, 66, 61 & 65 years, respectively. More patients in the BR cohort listed comorbidities (37%), with BTKi-treated patients reporting the least (19%). Pre-treatment disease burden (median IgM and hemoglobin) trended to being higher in the BR and DRC cohorts (figure 1B-D, IgM p=0.24, Hb p=0.27). At median follow up ranging from 31 to 39 months, BR had superior TTNT to DRC (median: not reached and 104 months, p=0.007, figure 1C) and Rit. (median 26 months, p < 0.0001, figure 1D), and trended to superiority compared to BTKi (median not reached, p=0.08, figure 1B). Median TTNT for the entire cohort (n=371) was 108 months (median follow up 55 months, figure 1A). Assessment of QoL was conducted in all patients (any line of treatment) and compared between patients currently on BTKi therapy (n=64) and patients not exposed to BTKi and treated within the last 12 months (n=84). The expanded BTKi cohort reported better QoL, with mean EORTC QLQ-C30 global scale of 82 ± 14.4 compared to the BTKi-naïve cohort mean 73.4 ± 20.9, p=0.005. This was despite more prior lines of treatment (median 2 [IQR 1-4] compared to 1 [IQR 1-1];p<0.0001). 324 (58%) patients responded to the COVID-19 questions. 144/324 (44%) had undergone testing for COVID-19, with 11 (8%) returning a positive result;none after vaccination. Median length of symptoms was seven days (range 2-30), with two hospitalized, one requiring intensive care. Both hospitalized patients were on second line ibrutinib. Of 211 responses regarding vaccination status, 15 (7%) were not vaccinated, eight due to availability, five due to personal choice and two due to clinician advice. Regarding impact of the pandemic on their WM management, 5% had treatment schedule disruption and 53% reported reduced face-to-face consultations. Conclusion: The WhiMSICAL registry provides a scientifically robust and ethically approved portal for the patients' voice. The data highligh the real-world efficacy of combination chemoimmunotherapy, particularly first-line BR, and suggest a better QoL with BTKi than other therapies. As this global data platform grows, the breadth of data allows for new insights into WM with patient reported outcomes advancing knowledge and facilitating treatment decisions for clinicians and patients. [Formula presented] Disclosures: D'Sa: Sanofi: Honoraria;BeiGene: Honoraria, Research Funding;Janssen Cilag: Honoraria, Research Funding. Kersten: Roche: Consultancy, Honoraria, Other: Travel support, Research Funding;Miltenyi Biotec: Consultancy, Honoraria, Other: Travel support;Novartis: Consultancy, Honoraria, Other: Travel support;BMS/Celgene: Consultancy, Honoraria;Takeda: Research Funding;Kite, a Gilead Company: Consultancy, Honoraria, Other: Travel support, Research Funding;Celgene: Research Funding. Thomas: Acerta Pharma: Research Funding;Ascentage Pharma: Research Funding;BeiGene: Membership on an entity's Board of Directors or advisory committees;BMS: Research Funding;Pharmacyclics: Membership on an entity's Board of Directors or advisory committees;X4 Pharma: Research Funding;Genentech: Research Funding. Palomba: Ceramedix: Honoraria;Rheos: Honoraria;Nektar: Honoraria;Priothera: Honoraria;Lygenesis: Honoraria;WindMIL: Honoraria;Wolters Kluwer: Patents & Royalties;Juno: Patents & Royalties;BeiGene: Consultancy;Kite: Consultancy;Magenta: Honoraria;Seres: Honoraria, Other: Stock, Patents & Royalties, Research Funding;PCYC: Consultancy;Notch: Honoraria, Other: Stock;Novartis: Consultancy;Pluto: Honoraria. Olszewski: Acrotech Pharma: Research Funding;Celldex Therapeutics: Research Funding;TG Therapeutics: Research Funding;PrecisionBio: Research Funding;Genentech, Inc.: Research Funding;Genmab: Research Funding. Trotman: PCYC: Research Funding;roche: Research Funding;BMS: Research Funding;TAKEDA: Research Funding;JANSSEN: Research Funding;beigene: Research Funding.

The epicenter of COVID-19 outbreak and quality of life (QoL) of patients with inborn errors of immunity (IEI): A sad reality

Background: The world is facing one of the worst pandemics in history. Its social, economic and psychological consequences will leave profound marks on society. This study evaluated the QoL of patients with IEI at an immunology referral centre, during the SARS-CoV-2 pandemic. Method: A prospective, single-center study with an adapted questionnaire was applied in two moments of the pandemic: from April to June 2020, and again in March 2021. IEI patients over 18 years old and the caregivers of children under this age answered it online. This questionnaire was adapted from the Portuguese version of the shortened WHO QoL-brief QoL assessment instrument (questions 1,2,4,5 e 26) and the 10-item version of the Perceived Stress Scale (questions 1,2 e 3), taking into account the past four weeks. Results: In the first three months analyzed (April to June/2020), 123/160 questionnaires were answered: 44.7% by caregivers and 55.3% by patients themselves. The children were 12-18 years old and adults were 18-45 years old. 91.1% of the patients have been receiving intravenous immunoglobulin replacement. 84.5% of the patients have already been hospitalized, and 38.2% of them in the intensive care unit at least once. All participants have heard of SARS-CoV-2 and 91% were afraid of being infected with the new virus. 81 patients (66%) reported good QoL prior to the pandemic and, after its onset, this percentage dropped to 27%. In March 2021, with the exponential increase in cases and deaths in Brazil, the questionnaire was reapplied, and 99/160 were answered, 52.4% by patients. The majority (72.6%) are between 18-45 years old, and only 8% of the responders reported good QoL. Everyone fears the coronavirus. Conclusion: Currently, Brazil is the epicenter of COVID-19 outbreak on the planet. In recent weeks, the number of new cases and deaths has grown wildly. Furthermore, IEI patients in Brazil had to deal with the lack of immunoglobulin supply throughout 2020, and until now. In the face of so much adversity, there is an urgent need to think about strategies to improve the QoL of these patients. This is one of the alerts of World primary immunodeficiencies (PI) Week 2021.

Capable: Comparing the patient generated index to standard quality of life measures in patients and caregivers affected by high-grade brain tumours-preliminary analysis

AIMS: High grade gliomas are rare but have the highest number of cancer deaths in the under-40s. Treatment options are limited, resulting in a clinical focus on maintaining quality of life (QoL). However standard QoL assessment tools are time consuming, may not reflect an individual's priorities, and are rarely used in clinical practice. Moreover, the impact of caring for someone with a high grade glioma is seldom assessed. An alternative approach to assessing quality of life is to use a patient-or carer-generated index (PGI/CaGI), which asks patients &carers to raise, rank and number their concerns. This may offer a route to individualised QoL assessments within clinical and research settings. The CaPaBLE study tests the feasibility and acceptability of the PGI and CaGI methodology in patients with high-grade glioma and their caregivers. This paper highlights key similarities and differences of the PGI/CaGI to standard QoL questionnaires. METHOD: CaPABLE is an observational phase 2 non-randomised study following patients and their caregivers over 6 months starting at either first diagnosis or recurrence (https://www.isrctn.com/ISRCTN45555598). Patients and caregivers complete both standard questionnaires (EORTC QLQ C30 &BN20 and CargoQOL) and PGI/CAGI at 5 timepoints over the 6 month period. Each time the patients/caregivers complete the PGI/CAGI they are asked to identify up to 5 main topics of concern for their QoL, to score these, and rank their importance. For this analysis, we grouped topics into themes, compared the stability of themes over time and to EORTC domains. Analyses of EORTC measures are conducted using standard scoring approaches. Here we present an initial analysis of occurrence of PGI/CaGI themes compared to EORTC domains, but do not consider scores or ranking. RESULTS: 6 patients (4 male) and 5 caregivers (3 female;4 paired with patients;one unpaired) have completed both standard questionnaire and PGI/CaGI at three or more time points, with a total of 19 (patient) and 18 (caregiver) assessments. On average people reported 3 topics at each assessment. The PGI generated 59 topics (32 themes);the CaGI, 50 topics (23 themes) and themes were consistent over time. The most common domain raised by patients was "social life" (13). Caregivers raised "personal life and family" (12 and "planning ahead" (7) more commonly. Of the 32 PGI themes, 23 align with EORTC domains. 9 PGI themes were not represented in the EORTC questionnaires, and 14 EORTC domains did not appear in the PGI. Of the 23 CaGI themes, 17 align with 7 CarGOQOL domains. 6 CaGI themes were not represented in the CarGOQOL and 3 CarGOQOL domains did not appear in the CaGI. CONCLUSION: PGI and CaGI themes coincide with the main domains of EORTC (i.e., cognitive, social, role, physical, emotional functioning, future uncertainty). However, there were significant discrepancies: PGI (e.g., intimacy, ability to drive, and COVID related restrictions) and CaGI (e.g. personal life &family) highlighted themes that are not in the standard questionnaires. Both PGI/CaGI and standard questionnaires agree that symptom-related issues such as pain and seizures are not the main priority when it comes to QoL. In addition, CarGOQOL reports positive aspects of care, whereas CaGI only raised negative areas. This study is the first to show the feasibility of PGI/CaGI in a brain tumour patient &caregiver population. PGI/CaGI are notably quicker to complete and provide insights not captured by standard questionnaires. We are continuing to recruit patients and caregivers, and have submitted a protocol amendment to carry out qualitative interviews with patients and caregivers, to explore their views further.

Effects of remote monitoring of patients with heart failure based on smartphone application in the context of the COVID-19 pandemic in the Kyrgyz Republic

Background: Patients with CHF were the most vulnerable during the COVID-19 pandemic. Given to reduce hospitalizations and outpatient appointments, remote monitoring of CHF patients using a mobile application in response to the COVID-19 pandemic has proven particularly relevant, providing continuous specialized medical care and ensuring social distancing. Purpose: To study the clinical effectiveness of the implementation of a mobile application for remote monitoring of patients with CHF compared with standard practice during the COVID-19 pandemic in a mountainous country. Methods: ERICA-HF is a randomized, controlled, open-label study. Were included patients with verified CHF III FC (NYHA) with randomization to the main group of remote monitoring of patients using a mobile application + standard treatment (n=200) or to the control group on standard outpatient follow-up at the place of residence (n=100), for 12 months. The assessment of the clinical course of CHF is carried out on the basis of clinical indicators that allow assessing the current state of patients, depending on the quantitative assessment of deviations above or below the threshold values, consisting of seven points: shortness of breath, position in bed, heartbeating, edema, weight, blood pressure, heart rate, which the patient fills twice a week, with the possibility of automatically notifying the doctor and the patient. The application is equipped with two-way feedback in the form of structured telephone support and online chat. Quality of life assessment according to the Minnesota Living With Heart Failure Questionnaire, the ability to self-control according to the scale EHFScBS-9. The primary outcome is the percentage of unplanned rehospitalizations for HF decompensation, quality of life, mortality from CHF. The main secondary outcomes are cost-effectiveness and adherence to treatment. Results: During the COVID-19 pandemic, 209 patients on remote monitoring with CHF from all regions (63% men, age 65±11 years) were observed by coordinating cardiologists, 24 of them got sick with COVID-19, 7 received hospital treatment due to the development of HF decompensation, pneumonia and respiratory failure, 3 died of pneumonia. 9 participants dropped out of the study due to Internet traffic interruptions. 95% of patients noted high compliance, confidence, gave a positive assessment and use of the mobile application. Conclusion: Remote monitoring using a mobile application was an effective means of managing patients with CHF in socially isolation. This suggests that remote monitoring using a smart phone can be a good alternative to outpatient practice, which we have demonstrated in the context of the COVID-19 pandemic. Also, the relatively low cost can greatly facilitate the implementation of remote monitoring programs using a mobile application.