Quality Of Life Assessment Research Articles

Quality of life assessment in diffuse large B-cell lymphoma (DLBCL) in REFLECT: a prospective, non-interventional, multicenter, German study, assessing Sandoz rituximab in combination with CHOP

Health-related quality of life (HRQoL) data are important indicators of health status in patients with lymphoma. The objective of this analysis was to assess the impact of treatment with Sandoz rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) on HRQoL in treatment-naïve adult patients with diffuse large B-cell lymphoma (DLBCL) included in the prospective, real-world REFLECT study. REFLECT is the first prospective study to assess HRQoL in patients with DLBCL treated with a rituximab biosimilar. HRQoL was assessed via the patient-reported European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire at baseline, mid-treatment (month 3), end of treatment (month 6), and follow-up (months 9 and 12). Subgroup analyses were performed to evaluate the influence of baseline characteristics on HRQoL, and associations between baseline HRQoL and treatment response. HRQoL was assessed in 169 patients. Mean global health status score remained stable from baseline (54.8) to mid-treatment (month 3; 54.7), before steadily improving through to end of treatment (month 6; 61.4), and follow-up month 9 (64.9) and month 12 (68.8). Similar trends were observed across most functional and symptom subscales. Higher cognitive, physical, or role functioning, and less appetite loss, diarrhea, fatigue, or pain at baseline, were all associated with an improved likelihood of reaching a complete versus partial response at the end of treatment. Overall, these findings confirm the HRQoL benefits of R-CHOP therapy in treatment-naïve adult patients with DLBCL, and suggest that baseline HRQoL may be predictive of treatment response.

Quality of Life of Colorectal Cancer Survivors: Mapping the Key Indicators by Expert Consensus and Measures for Their Assessment.

Quality of life (QoL) assessments are integral to cancer care, yet their effectiveness in providing essential information for supporting survivors varies. This study aimed to elucidate key indicators of QoL among colorectal cancer survivors from the perspective of healthcare professionals, and to evaluate existing QoL questionnaires in relation to these indicators. Two studies were conducted: a Delphi study to identify key QoL indicators and a scoping review of questionnaires suitable for colorectal cancer survivors. Fifty-four healthcare professionals participated in the Delphi study's first round, with 25 in the second. The study identified two primary QoL domains (physical and psychological) and 17 subdomains deemed most critical. Additionally, a review of 12 questionnaires revealed two instruments assessing the most important general domains. The findings underscored a misalignment between existing assessment tools and healthcare professionals' clinical priorities in working with colorectal cancer survivors. To enhance support for survivors' QoL, efforts are needed to develop instruments that better align with the demands of routine QoL assessment in clinical practice.

Real-Life Evidence of Mepolizumab Treatment in Chronic Rhinosinusitis with Nasal Polyps: A Multicentric Study

Background: The introduction of biological drugs in the management of chronic rhinosinusitis with nasal polyps (CRSwNP) is allowing new and increasingly promising therapeutic options. This manuscript aims to provide a multicenter trial in a real-life setting on Mepolizumab treatment for severe uncontrolled CRSwNP with or without comorbid asthma. Methods: A retrospective data analysis was jointly conducted at the Otolaryngology–Head and Neck Surgery departments of La Sapienza University and San Camillo Forlanini Hospital in Rome. Both institutions participated by sharing clinical information on patients with CRSwNP treated with Mepolizumab. Patients were evaluated before starting Mepolizumab, at six months and at twelve months from the first drug administration. During follow–up visits, patients underwent endoscopic evaluation, quality of life assessment, nasal symptoms assessment, and blood tests to monitor mainly neutrophils, basophils, eosinophils, and IgG, IgA, and IgE assay. Results: Twenty patients affected by CRSwNP and treated with Mepolizumab were enrolled (12 females and 8 males with a mean age of 63.7 years). Sixteen patients (80%) had concomitant asthma. During follow-up, a gradual improvement in nasal polyp score, quality of life and nasal symptoms, assessed by SNOT-22 and VAS and loss of smell measured by olfactory VAS, was found. Regarding blood tests, eosinophils decreased gradually, while other blood parameters showed no statistically significant changes. Conclusions: Mepolizumab has been shown to be effective in the therapeutic management of patients with CRSwNP. Further studies are needed to support our findings and better understand the underlying immune pathways to predict patients’ response to biological treatment in CRSwNP.

OTHR-23. PATIENT DESIRE TO SHARE DATA AND PARTICIPATE IN RESEARCH IN THE DIPG/DMG COMMUNITY

Abstract Direct and reciprocal communication between patient communities and their research and care teams is essential to building trust and ensuring that all essential information is shared. Patient participation in data collection of any sort is often challenging, as patients may be hesitant or unmotivated to share their information. The DIPG/DMG patient community faces the opposite challenge. Because of the frustration of the lack of treatment options and the established trust that exists between patient families and research professionals, DIPG/DMG patient families are both willing and eager to share any information they can. Patient families have seen how their knowledge has helped other families navigate impossible situations and care teams understand how to better support their patients. The information families eagerly provide is crucial to advancing treatment and research. Patient families have repeatedly expressed willingness to participate in quality of life assessments, repeated surveys during and after treatment, and provide their medical and biological information in the hopes that it can aid research. There is a need for a centralized manner for all of this data to be shared by the patient and accessed by care teams and researchers. Patient-led initiatives are addressing this by creating a network of resources. This network helps to guide other patient families through the data-sharing process, address concerns, and find ways to provide what is needed to push research and treatments ahead. There are many benefits to having a centralized data ecosystem for researchers and care teams, such as standardizing data collection and ease of analysis. In the future, this centralized hub could inform personalized care, making options such as n-of-1 trials and matching patients to optimal clinical trials possible in a manner that is effective and efficient.

A Comparative Randomized Clinical Study Assessing the Efficacy of a 1% Selenium Disulfide-Based Shampoo versus 2% Ketoconazole Shampoo in Subjects with Moderate to Severe Scalp Seborrheic Dermatitis

Introduction: Scalp seborrheic dermatitis (SSD) is a chronic, relapsing, and inflammatory condition impacting quality of life (QoL). This study evaluated the efficacy and impact on QoL of a 1% selenium disulphide-containing shampoo (SeS2 shampoo) compared to a 2% ketoconazole shampoo. Methods: This multi-centric, double-blinded, randomized 4-week study was conducted in 64 adult subjects with moderate to severe SSD (SSD severity score (SSSD) > 6). Shampoo was applied on the scalp and hair, according to product indications. Clinical examinations at baseline and on Day (D) 3, 7, 14, and 28 included the assessment of SSSD, total scales score (TSS, sum of adherent, and non-adherent scales), erythema, irritation, seborrhea, and itching. Self-evaluations included QoL and hair quality assessment (scales and greasiness). Results: The SSSD improved in both groups as early as D3, after one application of shampoo. This significant (p < 0.001) improvement was −71% for SeS2 and −69% for ketoconazole at D28. The decrease of the TSS was significant (p < 0.001) at D28 in both groups (−75% SeS2 and −68% for ketoconazole). The SSSD severity of all subjects decreased to mild at D28. Signs and symptoms had significantly (p < 0.001) improved in both groups after 28 days. QoL improved earlier with SeS2 than with ketoconazole shampoo. The cosmetic acceptability of SeS2 shampoo was higher than that of ketoconazole shampoo. Both shampoos were very well tolerated. Conclusion: SeS2 shampoo is a reliable and well-tolerated alternative care to ketoconazole shampoo in patients with moderate to severe scalp seborrheic dermatitis.

Comparative Analysis of Radial Forearm Free Flap and Submental Island Flap in Reconstruction of Post-glossectomy Defects of Oral Squamous Cell Carcinoma and Quality of Life Assessment

Comparative Analysis of Radial Forearm Free Flap and Submental Island Flap in Reconstruction of Post-glossectomy Defects of Oral Squamous Cell Carcinoma and Quality of Life Assessment

Nerve function impairment and quality of life in patients with leprosy: a prospective, observational study.

There is a limited number of studies assessing the alterations in nerve function impairment (NFI) in leprosy over an extended period of time. To the best of our knowledge, no published study has evaluated neurological state longitudinally during treatment utilizing a combination of clinical, functional (activity limitation), electrophysiological, and patient-reported quality of life (QOL) outcomes. This prospective, observational study included leprosy patients of all spectra. Over 1 year of treatment, cutaneous and neurological examinations were done in addition to a nerve conduction study (NCS) and sympathetic skin response (SSR) assessment. QOL and activity limitation assessments using the World Health Organization Quality of Life brief version (WHOQOL-BREF) and Screening of Activity Limitation and Safety Awareness scale (SALSA), respectively, were also performed. Out of 63 leprosy patients, loss of sensation was noted in 43 (68.2%) at baseline. At the completion of treatment, proportionate change revealed no change in 18 (28.5%), restored function in 9 (14.2%), improved status in 34 (53.9%), and deteriorated NFI in only 2 (3.1%) cases. The association between NCS-SSR abnormalities was significant for a longer duration of disease at presentation (P = 0.04), in multibacillary cases [OR 9.12 (95% CI, 1.22-67.93)], in those in reaction [OR 3.56 (95% CI, 0.62-20.36)] and in those aged over 40 [OR 1.93 (95% CI, 0.28-13.41)]. There was an improvement in WHOQOL-BREF and SALSA scores at release from treatment (P = 0.005 and P = 0.01, respectively). The majority of leprosy patients on treatment show improvement in NFI at the completion of therapy. However, change is influenced by critical factors such as bacillary load, disease duration, age, and the presence of reaction(s).

Vagal Nerve Stimulation in the Pediatric Population and Correlation Between Family and Treatment Team Perspectives: Single-center Experience.

Vagal nerve stimulation (VNS) is an adjunctive therapy to pharmacological treatment in patients with drug-resistant epilepsy. This study aimed to assess the efficacy of VNS therapy for seizure frequency reduction and improving quality of life (QOL) measures in children with refractory epilepsy and to evaluate the correlation between the perspectives of families and those of the treating team. This was a prospective cohort study conducted at Abha Maternity and Children's Hospital, Saudi Arabia, from 2018 to 2022. A total of 21 pediatric patients who completed one year of follow-up after VNS implantation were included. Patients were aged between 2 and 14 years, with a mean age of 8.14 ± 3.92; 11 (52.4%) patients were female. Family and physician assessments were collected blinded to each other using Clinical Global Impression of Improvement (CGI-I) scores and QOL assessments to evaluate the correlation between the families' and treating team's perspectives on VNS outcomes. In this study involving 21 patients with intractable epilepsy, VNS showed significant efficacy in reducing the frequency of seizures. VNS significantly reduced the number of seizures per week from a baseline median of 35 to a median of 0.25 at the end of the follow-up period, representing a dramatic reduction of 99.3% (p < 0.001). The number of emergency department visits per year decreased from a baseline median of 12 to a median of 2, a reduction of 83.3% (p < 0.001), whereas the number of hospital admissions per year decreased from a baseline median of 3 to a median of 1, a 66.7% decrease (p < 0.001). The number of antiepileptic medications taken decreased from a median of 4 to 3 (p < 0.001). Notably, 28.57% of the patients achieved complete seizure freedom, and 38% exhibited significant improvement, with at least 50% reduction in seizure frequency. Importantly, none of the patients experienced an escalation in seizure frequency following VNS treatment. The family and physician assessments showed varying degrees of alignment in perceptions, with "concentration" exhibiting a significant positive correlation (r = 0.498, p = 0.022), indicating noteworthy agreement, whereas verbal communication did not show a substantial correlation (r = -0.062, p = 0.791), indicating a divergence of views. VNS is a promising and well-tolerated therapy for individuals with intractable seizures, offering clinical benefits and potential enhancements in various aspects of QOL. The varying perceptions between family and physician assessments highlight the importance of considering multiple perspectives when evaluating treatment outcomes.

Perforator versus Non-Perforator Flap-Based Vulvoperineal Reconstruction-A Systematic Review and Meta-Analysis.

Patients with advanced vulvoperineal cancer require a multidisciplinary treatment approach to ensure oncological safety, timely recovery, and the highest possible quality of life (QoL). Reconstructions in this region often lead to complications, affecting approximately 30% of patients. Flap design has evolved towards perforator-based approaches to reduce functional deficits and (donor site) complications, since they allow for the preservation of relevant anatomical structures. Next to their greater surgical challenge in elevation, their superiority over non-perforator-based approaches is still debated. To compare outcomes between perforator and non-perforator flaps in female vulvoperineal reconstruction, we conducted a systematic review of English-language studies published after 1980, including randomized controlled trials, cohort studies, and case series. Data on demographics and surgical outcomes were extracted and classified using the Clavien-Dindo classification. We used a random-effects meta-analysis to derive a pooled estimate of complication frequency (%) in patients who received at least one perforator flap and in patients who received non-perforator flaps. Among 2576 screened studies, 49 met our inclusion criteria, encompassing 1840 patients. The overall short-term surgical complication rate was comparable in patients receiving a perforator (n = 276) or a non-perforator flap (n = 1564) reconstruction (p* > 0.05). There was a tendency towards fewer complications when using perforator flaps. The assessment of patients' QoL was scarce. Vulvoperineal reconstruction using perforator flaps shows promising results compared with non-perforator flaps. There is a need for the assessment of its long-term outcomes and for a systematic evaluation of patient QoL to further demonstrate its benefit for affected patients.

DEPRESSION AND QUALITY OF LIFE IN PATIENTS WITH PEMPHIGUS: A CROSS-SECTIONAL STUDY

Objective: The objective of the study is (1) to analyze the prevalence and severity of depression in cases of pemphigus and (2) to study the association of demographic factors with the presence of depression in cases with pemphigus. Methods: A cross-sectional single-interview study was carried out on 100 consecutively selected patients with pemphigus attending the dermatology out-patient department in a tertiary care hospital. The assessment was done with semi-structured pro forma, Beck depression inventory (BDI), and quality of life (QoL) measure – Skindex-16. The Statistical Package for the Social Sciences 24.0 was used for statistical analysis and p&lt;0.05 was taken as statistically significant. Results: Out of 100 cases, there were 60 (60%) males and 40 (40%) were females with M: F ratio of 1:0.66. The mean age of male and female patients was found to be comparable with no statistically significant difference (p=0.6061). The majority were married, employed, and from rural backgrounds. 22% satisfied the Diagnostic and Statistical Manual for Mental Disorders 5th edition criteria for major depressive disorder. Assessment using BDI in these patients for severity of depression showed mild depression in 12%, moderate depression in 7%, and severe depression in 3%. Patients having a longer duration of illness and a history of frequent hospitalization were found to have significantly high scores on the subscale for depressive symptoms. QoL assessment using the Skindex-16 scale among these patients showed that they experienced more severe emotional and symptomatic effects due to skin disease compared to functional effects, especially during relapse. Those who had poor QoL showed significantly high scores on the subscale for depressive symptoms. Conclusion: More than 20% of patients of pemphigus had diagnosable depression with significant effects on QoL. Therefore, regular screening for depression is important in pemphigus patients as it will help in planning early intervention.

Direct comparative study of anti-IgE and anti-IL4Rα therapy effectiveness in patients with severe allergic and mixed bronchial asthma

Introduction. There is insufficiency of direct comparative studies of genetically engineered biological drugs (GEBD) for severe bronchial asthma (SA) treatment in scientific databases.Aim. To compare omalizumab and dupilumab effectiveness in patients with allergic and mixed SA in real clinical practice.Materials and methods. The direct comparative study included SA patients with an allergic component from regional registry of Sverdlovsk region. The data of patients with allergic (n = 68) and mixed (n = 27) SA treated with omalizumab (n = 62) and dupilumab (n = 33) were analyzed. Therapy effectiveness was determined for 12 months in general group No. 1, allergic asthma group No. 2 and mixed asthma group No. 3 according to the following indicators: asthma control level (ACT), proportion of patients with uncontrolled asthma, need for systemic glucocorticosteroids (SGCS) and short‐acting beta agonists (SABA), basic therapy volume, asthma exacerbations number, emergency calls and hospitalizations, forced expiratory volume in the first second (FEV ), assessment of life quality (AQLQ and SNOT-22). Control evaluation visits were conducted before therapy start, after 4 and 12 months of biologics taking.Results. In general, during the 12 months of targeted therapy in patients receiving omalizumab statistically significant positive dynamics was observed in 12 of the 13 evaluated indicators; in patients receiving dupilumab – in 9 indicators. When analyzing such indicators as, ACT, taking SGCS, exacerbations of SA, FEV , statistically significant positive dynamics was revealed for all 4 indicators in patients receiving omalizumab in group No. 2 and in patients receiving dupilumab in group No. 3.Conclusions. Patients with allergic component of SA respond equally well to therapy with omalizumab and dupilumab. At the same time, a tendency towards the advantage of omalizumab in patients with allergic asthma, and dupilumab in patients with a mixed phenotype of the disease was revealed.

Unravelling Quality of Life for Head and Neck Cancer Patients after VMAT Radiation Therapy: Insights from Toxicity, Dosimetry and Symptoms Correlation.

(1) Background: Head and neck cancer treatment, including advanced techniques like Volumetric Modulated Arc Therapy (VMAT), presents challenges for maintaining patient quality of life (QoL). Thus, thoroughly investigating how radiation therapy (RT) affects patients has been proved essential. Derived by that, this study aims to understand the complex interactions between not only RT and QoL but also symptom severity, and treatment-related toxicities in three distinct time points of patient's treatment; (2) Methods: To achieve that, EORTC-QLQ-C30 and EORTC QLQ-H&N35 questionnaires were used in combination with EORTC_RTOG scoring criteria and Spearman's rho statistical analysis for 74 patients with cancer undergoing VMAT radiation therapy; (3) Results: The results revealed a significant improvement in the Overall Health Index post-treatment, indicating a temporary decline during therapy followed by subsequent recovery, often surpassing pre-treatment QoL levels. Concurrently a reduction in symptomatology was observed, notably in pain, swallowing difficulties, and dry mouth, aligning with prior research indicating decreased symptom burden post-treatment. However, Spearman's correlation coefficient analysis at two distinct time points during therapy uncovered varying degrees of correlation between dosimetric data at Organs at Risk (OARs) and reported symptoms, highlighting potential limitations in using QoL questionnaires as sole indicators of treatment efficacy. Our investigation into the correlation between dosimetric data, toxicity, and symptoms focused on the relationship between radiation doses and oral mucositis levels, a common toxicity in head and neck cancer patients. Significant associations were identified between toxicity levels and dosimetric parameters, particularly with OARs such as the parotid glands, oral cavity, and swallowing muscles, underlining the utility of the EORTC method as a reliable toxicity assessment tool; (4) Conclusions: To summarize, current research attempts to underscore the importance of refining QoL assessments for enhanced patient care. The integration of dosimetric data, symptom severity, and treatment-related toxicities in the QoL outcomes of head and neck cancer patients undergoing VMAT radiation therapy, can lead towards the optimization of treatment strategies and the improvement of patient outcomes in future patient-centered radiation therapy practices.

Telemedicine With Wearable Technologies in Patients Undergoing Hematopoietic Cell Transplantation and Chimeric Antigen Receptor T-Cell Therapy (TEL-HEMATO Study): Prospective Noninterventional Single-Center Study.

Patients with hematological malignancies receiving hematopoietic cell transplantation (HCT) or chimeric antigen receptor (CAR) T-cell therapy are at risk of developing serious clinical complications after discharge. The aim of the TEL-HEMATO study was to improve our telehealth platform for the follow-up of patients undergoing HCT or CAR T-cell therapy during the first 3 months after discharge with the addition of wearable devices. Eleven patients who received autologous (n=2) or allogeneic (n=5) HCT or CAR T-cell therapy (n=4) for hematological malignancies were screened from November 2022 to July 2023. Two patients discontinued the study after enrollment. The telehealth platform consisted of the daily collection of vital signs, physical symptoms, and quality of life assessment up to 3 months after hospital discharge. Each patient received a clinically validated smartwatch (ScanWatch) and a digital thermometer, and a dedicated smartphone app was used to collect these data. Daily revision of the data was performed through a web-based platform by a hematologist or a nurse specialized in HCT and CAR T-cell therapy. Vital signs measured through ScanWatch were successfully collected with medium/high adherence: heart rate was recorded in 8/9 (89%) patients, oxygen saturation and daily steps were recorded in 9/9 (100%) patients, and sleeping hours were recorded in 7/9 (78%) patients. However, temperature recorded manually by the patients was associated with lower compliance, which was recorded in 5/9 (55%) patients. Overall, 5/9 (55%) patients reported clinical symptoms in the app. Quality of life assessment was completed by 8/9 (89%) patients at study enrollment, which decreased to 3/9 (33%) at the end of the third month. Usability was considered acceptable through ratings provided on the System Usability Scale. However, technological issues were reported by the patients. While the addition of wearable devices to a telehealth clinical platform could have potentially synergic benefits for HCT and CAR T-cell therapy patient monitoring, noncomplete automation of the platform and the absence of a dedicated telemedicine team still represent major limitations to be overcome. This is especially true in our real-life setting where the target population generally comprises patients of older age with a low digital education level.

Effectiveness of Abdominal Massage Versus Kinesio Taping in Women With Chronic Constipation: A Randomized Controlled Trial.

Chronic constipation is an important public health problem and significantly affects women's lives. It is important to investigate nonpharmacological applications that can be used in the treatment of chronic constipation. The aim is to assess how abdominal massage and Kinesio taping impact constipation severity, quality of life (QOL), and perception of subjective improvement in women with chronic constipation. Following the Rome IV diagnostic criteria, women with constipation were randomly sorted into 3 distinct groups for study: massage group (lifestyle recommendations + abdominal massage, n = 22), taping group (lifestyle recommendations + Kinesio taping, n = 22), and control group (lifestyle recommendations, n = 22). Constipation Severity Instrument (CSI) (for constipation severity), 7 days bowel diary (for bowel function), Patient Assessment of Constipation QOL (PAC-QOL) questionnaire (for QOL), 4-item Likert-type scale (for perception of subjective improvement) was used. The group x time interaction effect was significant in all CSI, bowel diary and PAC-QQL parameters, except for incomplete evacuation and PAC-QOL-worries/concerns, and a large effect size was found (Partial η2 > 0.14). Improvement scores of all parameters (except CSI-obstructive defecation, incomplete evacuation, PAC-QOL-worries/concerns) were similar in the massage and taping groups and were better than the control group. Noteworthy perceptions of subjective improvement and normalization of stool type predominantly manifested in the massage group (P < 0.05). Abdominal massage and Kinesio taping are recommended as initial conservative interventions for managing chronic constipation within the therapeutic spectrum.

Beyond the heart: Cognitive and verbal outcomes in Arab children with congenital heart diseases.

This study investigates how congenital heart diseases (CHD) characteristics and interventions affect cognitive and verbal skills in Arab children, while also uncovering previously unexplored connections between these skills and the quality of life (QoL) scores as perceived by both children and parents. A cross-sectional study was conducted in Jordan, involving 62 children with CHD aged 6-16. Data were collected through standardized intelligence tests (namely The Raven's Progressive Matrices Test and The Wechsler Intelligence Scale for Children) and QoL assessments. Sex, disease severity, cyanosis, CHD defect status, conducted operations, and types of interventions did not significantly influence cognitive scores. However, a significant difference was observed in Wechsler's scores between cyanotic and non-cyanotic children (p < .01) and between severe and moderate cases (p = .01). Further, a significant positive correlation was identified between Wechsler's Scores and QoL reported by parents (r = 0.33, p < .01). This correlation was particularly pronounced in the social and school functioning dimensions of QoL. This study highlights the need for personalized care approaches for children with CHDs based on their individual characteristics. While cognitive abilities did not directly correlate with children's QoL reports, a significant positive correlation between verbal skills and QoL reported by parents underscores the importance of effective communication in assessing a child's overall well-being. Future research should further examine the cognitive development in this population, employing neurocognitive investigations and longitudinal studies to gain a deeper understanding of their cognitive profiles and trajectories.

Body and mind and self-consciousness awareness workshops: Improving quality of life in patients with cancer.

e24081 Background: Cancer patients, commonly experience disease and treatment related stress, anxiety and difficulties coping with life. Data suggests that body and mind are interrelated and can influences patients' quality of life (QOL). Objectives: The study aimed to evaluate the impact of patients body and mind work developing self consciousness awareness and changing behavioral patterns of women’s cancer patients, on quality of life and coping abilities. By evaluation of QOL, sleep disorders and anxiety tests done during and following our workshop. Methods: The study conducted at the Women's Cancer Center of Tel Aviv Sourasky Medical Center in Tel Aviv Israel between 2022-2024. Female cancer patients and survivors, were enrolled in workshops teaching self consciousness awareness development according to the Metaism methodology. Each workshop with groups of 10-15 patients was conducted weekly for three months, The groups were led by dedicated moderators and supervised by a psychiatrist. Patients completed a validated QOL questionnaire, sleep disorder evaluation and anxiety questionnaires, upon enrollment and every month during the workshop and up to a year from completion of the workshop. Results: one-hundred and twofemale patients diagnosed with cancer and treated at multiple cancer centers were included in the study. Patient mean age was 57 (26-75) years. Patient diagnoses included breast, ovarian, uterine, cervical, and other cancers (58%, 22%, 7%, 5%, respectively). Significant improvement was observed in the QOL assessment at the 5th week of the workshop, overall educational well-being indicator at the 3rd week of the workshop, emotional well being at the 3rd week of the workshop, physical well-being at the end of follow up. Conclusions: The study demonstrated that integrating the metaism methodology of self consciousness awareness development workshops significantly improved patient coping ability and QOL. Further investigation of larger cohorts is warranted.

Patient-centered perspectives: Examining quality-of-life integration in phase III lung cancer trials (2019-2023).

e23181 Background: In the dynamic landscape of lung cancer treatment, marked by precision medicine advancements, addressing the persistent global health challenge of lung cancer requires nuanced evaluations beyond traditional endpoints like Overall Survival (OS). Aligned with the emphasis on patient-centered care, both the US FDA and ASCO advocate for consistent integration of Quality of Life (QoL) and Patient-Reported Outcomes (PRO). The FDA's 2021 guidance underscores standardized assessment strategies, and ASCO's conceptual framework highlights the pivotal role of QoL and PRO data in elucidating the genuine value of cancer treatment options. This investigation aims to illuminate the extent to which recent trials consider patients' subjective experiences without presupposing an impact on QoL. Methods: This systematic review analyzed PubMed for Phase III lung cancer clinical trials involving anticancer drugs conducted between 2019 and 2023 to assess if QoL was included as an endpoint. Subgroup analyses categorized trials by cancer subtype (e.g., non-small cell lung cancer [NSCLC], small cell lung cancer [SCLC]). Analyses were also stratified by publication year to explore potential temporal trends. The total prevalence of QoL as an endpoint was calculated across all lung cancer subtypes for the entire 5-year period. Subanalyses included impact factor categories (≥ 10 and &lt; 10) and differentiation between superiority and noninferiority trials. Results: The systematic analysis identified 191 Phase III lung cancer clinical trials published between 2019 and 2023, meeting the criteria. QoL was included in 31.93% of trials across all subtypes. Subgroup analyses showed that 33.72% of NSCLC trials incorporated QoL, with variations observed in early-stage resectable disease (26.31%) and unresectable advanced and metastatic cases (34.66%). For SCLC, 19.04% of trials included QoL, with none in the limited stage and 22.22% in the extensive stage. Stratified by publication year, 2019 had 33.33%, 2020 had 39.02%, 2021 had 33.33%, 2022 had 23.33%, and 2023 had 28.94% trials with QoL assessments. Stratification based on impact factor (IF) and trial type revealed 29.4% in Journals ≥10 IF, 35.6% in Journals &lt; 10 IF, 35.5% in superiority trials, and 21.6% in non-inferiority trials. Conclusions: Our analysis reveals a significant shortfall in incorporating QoL as an endpoint. Across all subtypes and stages, a limited percentage of trials included PRO, highlighting a crucial gap in evaluating the comprehensive impact of interventions. The underrepresentation of QoL assessments signals a need for greater attention to the holistic patient experience in lung cancer research. Moving forward, a more standardized and comprehensive integration of QoL assessments in Phase III trials is essential to enhance our understanding of treatment impact and inform more patient-centered care decisions.

Randomized Pilot Trial of Pre- and Postoperative Heart Failure Nurse-Supported Care in Heart Failure Patients Requiring Noncardiac Surgery-Feasibility and Results.

The perioperative cardiovascular management of patients undergoing noncardiac surgery is particularly challenging in those with pre-existing heart failure (HF). This study was designed to evaluate the effectiveness of nurse-based pre- and postoperative specialized HF management in reducing postoperative HF-associated complications in patients with known HF undergoing noncardiac surgery. This prospective, randomized pilot study included patients with established HF requiring intermediate- to high-risk noncardiac surgery. Patients received postoperatively either standard care (control group, CG) or nurse-supported HF management (intervention group, IG). The primary endpoint was a composite of HF-related postoperative complications at 30 days. Secondary endpoints included length on intensive care unit, length of hospital stay, death, hospitalization for HF, and quality of life assessment using the SF-12 questionnaire. The trial was halted prematurely for futility. A total of 34 patients (median age 70.5 [IQR 67-75] years; with 15 HfpEF, 9 HfmrEF,10 HfrEF), with an average NT-proBNP of 1.413 [463-2.832] pg/mL were included. The IG had a lower rate of postoperative primary events (25%; n = 4) compared with the CG (33%; n = 6). There were no differences in secondary endpoints between the groups. Quality-of-life scores improved slightly in both groups (δ 5.6 ± 0.9 [CG] and 3.1 ± 1.2 [IG]). Nurse-based pre- and postoperative HF care appears to be feasible and may reduce HF-associated complications in patients undergoing noncardiac surgery. Larger clinical trials are needed to further evaluate the effectiveness of this approach in reducing postoperative complications in this high-risk patient population.

Molecular residual disease (MRD) interception in locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC): MERIDIAN study.

TPS6122 Background: The detection of circulating tumor DNA (ctDNA) after definitive treatment or MRD is associated with recurrence across different tumor types. We previously showed that ctDNA detection using a bespoke tumor-informed assay (RaDaR), in LA-HNSCC patients (pts) after surgery, definitive radiation (RT) or chemoRT (CRT), is associated with recurrence within a year (Sanz-Garcia et al, ASCO 2023). To date, the impact of intercepting MRD prior to progression in HNSCC has not been explored. Anti-PD-1 blockade has shown benefit in recurrent/metastatic HNSCC but the efficacy in LA-HNSCC is still uncertain. TIGIT is overexpressed in HNSCC and could be a potential target to improve immunotherapy (IO) outcomes. Rilvegostomig (AZD2936) is a monovalent bispecific TIGIT/PD-1 antibody that has shown acceptable safety in phase I studies, currently in phase III studies. We hypothesize that IO (AZD2936) could induce ctDNA clearance post-definitive treatment and avoid, or delay recurrence. Methods: This study will recruit 200 pts with high-risk LA-HNSCC treated with curative intent: surgery ± adjuvant therapy, definitive RT or CRT; stage III Human Papilloma virus (HPV) positive or III-IVB HPV negative. Archival tissue must be available for whole exome sequencing (WES). Pts will be enrolled in part A (definitive therapy) and part B (follow up – FU - post-definitive therapy). Plasma samples will be collected in part A (pre-treatment and post-surgery prior to adjuvant therapy) and part B (at 4-6 weeks: FU1 and 8-12 weeks: FU2). These FU samples will be analyzed in real time for ctDNA using RaDaR, an assay that targets patient specific somatic variants identified by WES of matched tumor tissue. MRD+ pts (defined as having ctDNA detected at FU2) will be enrolled to part C (interception) and randomized 3:1 to receive AZD2936 750mg IV q3w for 6 cycles or observation. 30% of pts (N=60) will be enrolled in part C. Tumor must be positive for PD-L1 (CPS≥1) and there should not be residual primary tumor or distant metastases at FU2; residual lymph nodes are allowed if neck dissection is performed. Part D will consist of long term FU of MRD+ pts; RaDaR will be performed at week 2 (W2) and week 10 (W10), and radiological assessments will be performed at W2. MRD- pts will be enrolled in part E (long term FU). The primary endpoint of MERIDIAN is ctDNA clearance in MRD+ pts, defined as no detection of ctDNA at Part D W2 and W10. We will have 87% power to identify a significant improvement in ctDNA clearance rate from 10% (observation) to 40% (AZD2936) given a significance level of 0.1. Secondary objectives include survival and safety. Exploratory analyses include: ctDNA detection using other assays (HPV DNA, methylated ctDNA), ctDNA detection in part E and beyond W10 in part D, quality of life assessments (FACT-ICM, EORTC-HN43), health economics and radiomics. As of February 2024, 19 patients are recruited. Clinical trial information: 05414032.

Identifying and addressing real-world challenges to triple-negative breast cancer (TNBC) care: A quality improvement initiative.

e13143 Background: Recent introduction of novel therapies into advanced TNBC management has greatly increased complexity of care. This study aimed to identify real-world challenges and practice gaps in evidence-based treatment for TNBC in the community oncology setting. Methods: In March-August 2023, 48 health care providers (HCPs) at 4 US community oncology clinics completed surveys on practice gaps and challenges related to care delivery, treatment selection, adverse event management, and shared decision making (SDM) in TNBC. HCPs (n=47) then participated in audit/feedback (AF) sessions to review clinical evidence and develop clinic-specific action plans to address identified gaps. Follow-up surveys evaluated the impact of real-world clinical practice changes stemming from the initiative. Results: HCPs reported sequencing of therapies across multiple lines of treatment, coordinating care and care transitions, and providing patient-centered supportive care as their top 3 challenges. They also reported challenges with managing adverse events, particularly neutropenia (46%) and cardiotoxicity (25%). Most HCPs (~70%) reported providing nutritional support services, healthy lifestyle counseling, and financial counseling, while distress screening, quality of life assessment, and end-of-life counseling were less frequently used (~40%). Two-thirds of HCPs said that they often or always engaged in SDM with their patients, with top barriers identified as lack of time, patients’ low health literacy, and lack of support staff. Changes that were considered most likely to improve care were improved collaboration across interprofessional teams (31%) and improved follow-up and monitoring for early signs of recurrence/progression (21%). When asked about support necessary to for changes across their healthcare system, HCPs selected improved workflows/protocols to support collaboration across disciplines (tumor boards, specialty care teams, etc) as their top resource need. After the AF sessions, action plans included use of new communication channels to discuss patient side effects or confirm plans for biomarker testing, improved treatment sequencing protocols, workflow standardization for patients transitioning to specialty care teams, and implementation of checkpoints to ensure continued patient engagement and timely identification of adverse events. On a follow-up survey, clinics reported they had improved follow-up and monitoring for adverse events (83%) and were engaging patients more frequently in SDM (67%). Conclusions: Community oncology clinics face multiple ongoing challenges that may be impeding the ability to integrate newer therapies into TNBC management. Further research on multidisciplinary communication, collaboration, and needed workflow changes has the potential to improve care for patients with TNBC.