Global Quality Of Life Scale Research Articles

Patient-reported symptom interference with activity- and mood-related functioning prior to start of an early-phase oncology combination trial including immune checkpoint blockade.

12084 Background: We examined symptom interference with activity- and mood-related functioning at baseline in early-stage trials of combination treatments that included at least one immune checkpoint inhibitor, and its association with quality of life (QOL)-, clinical-, and trial-related factors. Methods: Patients scheduled to begin an early-phase trial of a combination treatment with immune checkpoint blockade, and who had not received trial-related treatment were recruited into a prospective longitudinal study design (NCI R01CA242565), and completed the following validated patient-reported outcome (PRO) measures prior to trial start: MD Anderson Symptom Inventory- Immunotherapy (score range: 0-10, higher scores = worse symptom interference); NCI’s PRO Common Terminology Criteria for Adverse Events (0-4, higher = worse severity); EuroQoL-5 dimensions assessing health status (0-100, higher = better health) and problems with self-care, and the Sloan Global QOL scale (0-10, higher = better QOL). Statistical tests included Spearman’s correlation rho (r) and multivariable linear regression. Results: 977 baseline PRO measures were completed by 247 patients (median age = 59 y; 46% female). Worst symptom-related interference was with activity (3.0 on a 0-10 scale), work (2.9), and enjoyment of life (2.4). Composite score means were 2.8 for symptom interference with walking, activity, and work (WAW; activity-related functioning), and 2.1 for interference with relationships, enjoyment of life, and mood (REM; mood-related functioning). Symptoms most associated with worse WAW were fatigue (P<0.001) and appetite loss (P=0.001). Worse WAW was linked to worse REM (r=0.78, P<0.001). Diminished sexual interest/mood (DSI) was associated with worse WAW (r=0.35, P<0.001) and REM (r=0.33, P<0.001). Worse WAW was linked to shorter trial duration (P=0.003) and worse response (progression of disease/immune-related progression) on the clinical trial (P=0.05). Conclusions: This first, comprehensive and prospective examination of symptom interference with functioning at trial baseline found that worse symptom interference was linked to worse QOL, poorer clinical outcomes, and shorter trial duration. These findings suggest that baseline patient-reported symptom interference with functioning can serve as a potential biomarker of poor prognosis in investigational trials, and that trial patients may benefit from initiation of supportive care prior to trial start. [Table: see text]

Internal Responsiveness of EQ-5D-5L and EORTC QLQ-C30 in Dutch Breast Cancer Patients during the First Year Post-Surgery: A Longitudinal Cohort Study.

The EuroQoL 5-Dimension 5-Level questionnaire (EQ-5D-5L) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) are commonly used Patient-Reported Outcome Measures (PROMs) for breast cancer. This study assesses and compares the internal responsiveness of the EQ-5D-5L and EORTC QLQ-C30 in Dutch breast cancer patients during the first year post-surgery. Women diagnosed with breast cancer who completed the EQ-5D-5L and EORTC QLQ-C30 pre-operatively (T0), 6 months (T6), and 12 months post-surgery (T12) were included. Mean differences of the EQ-5D-5L and EORTC QLQ-C30 between baseline and 6 months (delta 1) and between baseline and 12 months post-surgery (delta 2) were calculated and compared against the respective minimal clinically important differences (MCIDs) of 0.08 and 5. Internal responsiveness was assessed using effect sizes (ES) and standardized response means (SRM) for both deltas. In total, 333 breast cancer patients were included. Delta 1 and delta 2 for the EQ-5D-5L index and most scales of the EORTC QLQ-C30 were below the MCID. The internal responsiveness for both PROMs was small (ES and SRM < 0.5), with greater internal responsiveness for delta 1 compared to delta 2. The EQ-5D-5L index showed greater internal responsiveness than the EORTC QLQ-C30 Global Quality of Life scale and summary score. These findings are valuable for the interpretation of both PROMs in Dutch breast cancer research and clinical care.

The Sarcoma Assessment Measure (SAM): Preliminary Psychometric Validation of a Novel Patient-Reported Outcome Measure.

The Sarcoma Assessment Measure (SAM) was developed as a sarcoma-specific patient-reported outcome measure to be used in clinical practice. We have reported in detail how SAM has been developed in collaboration with patients and healthcare professionals. The aim of this paper is to report the preliminary validation of SAM. The 22-item SAM was administered alongside a validated quality of life questionnaire and measure of activities of daily living. Linear modelling was used to build a measure, which had predictive validity in comparison to more established outcome measures. Of the 762 patients who participated in the study, 44.1% identified as male, and participant age ranged from 13 to 82 years. Clinically, participants presented with a range of soft tissue (82.2%) and bone (21.8%) sarcomas. Our preliminary analysis indicates that SAM accounts for 35% of the global quality of life scale and 18% of the Toronto Extremity Salvage Scale (TESS); so psychometrically, it overlaps with quality of life and activities of daily living, but also measures distinct concerns. This demonstrates that this measure picks up issues that are important to patients with sarcoma that are not reflected in other measures. We have established the preliminary validity of SAM and believe it has utility as a patient-reported outcome measure both as a research tool and for assessing the impact of symptoms and dysfunction related to sarcoma as part of clinical care. Further validation using a larger and more clinically diverse sample is now needed.

Baseline functioning scales of EORTC QLQ-C30 predict overall survival in patients with gastrointestinal cancer: a meta-analysis.

A consensus has not been reached on the value of quality of life (QoL) as a prognostic factor for survival in gastrointestinal cancer. This meta-analysis aimed to investigate the association between functioning scales of the EORTC QoL Questionnaire Core 30 (QLQ-C30) and the overall survival (OS) in patients with gastrointestinal cancer. A systematic literature search was conducted in PubMed, Web of Science, and Embase databases, until February 7, 2023. The studies included were those that investigated the association between baseline QoL measured by the functioning scales of EORTC QLQ-C30 and OS in patients with gastrointestinal cancer. The prognostic capacity of QoL was calculated by pooling the adjusted hazard ratios (HR) with 95% confidence intervals (CI). Twenty-four studies' analyses reported by 22 eligible articles involving 11,609 patients were included. When compared with good parameters of QoL, poor global QoL (HR 1.81; 95% CI 1.53-2.13), physical functioning (HR 1.51; 95% CI 1.31-1.74), social functioning (HR 1.67; 95% CI 1.30-2.15), and role functioning scale (HR 1.42; 95% CI 1.20-1.29) were significantly associated with decreased OS. For each 10-point increase in QLQ-C30 parameters, the pooled HR of OS was 0.87 (95% CI 0.83-0.92) for global QoL, 0.87 (95% CI 0.83-0.92) for physical functioning, and 0.93 (95% CI 0.88-0.97) for role functioning. However, each 10-point increase in social, emotional, or cognitive functioning scale did not significantly predict OS. Baseline health-related QoL defined by the physical functioning or global QoL scale of EORTC QLQ-C30 significantly predicts OS in patients with gastrointestinal cancer.

Validation of an ultra-short global quality of life scale in a large population-based health survey.

Quality of life (QoL) assessment is essential in health-related research and clinical settings, offering insights into individuals' well-being and functioning. This study validated the Essential QoL-3 (EQoL-3), an ultra-short scale assessing essential dimensions of QoL, for use in epidemiological research and clinical settings. Data from a 2021 national survey in Norway (N = 17,487) were used. Three items on the EQoL-3 assess life satisfaction, happiness, and meaningfulness on a 0-10 scale. Discriminant validity was assessed by comparing the EQoL-3 with the Satisfaction with Life Scale (SWLS) and by examining latent mean differences between individuals with adverse life experiences (ALE+) and those without such experiences (ALE-). Convergent validity was evaluated through latent regression analyses comparing the EQoL-3 with a perceived mastery scale and a mental distress scale. The discriminant validity of the EQoL-3 was less than optimal when compared with the SWLS. Nonetheless, a multigroup confirmatory factor analysis revealed that the EQoL-3 score was 1.42 (95% CI = 1.33-1.50, p < 0.001) lower in the ALE+ group compared to the ALE- group, providing support for discriminant validity. Convergent validity was established with a positive association between EQoL-3 and mastery (β = 1.75, 95% CI = 1.70-1.80, p < 0.001) and a negative association between the EQoL-3 and mental distress (β = -2.64, 95% CI = -2.71/-2.59, p < 0.001). The EQoL-3 is a reliable measure of QoL. Its streamlined nature facilitates quick administration, making it a valuable tool for clinicians and researchers in diverse settings. Its inclusion of the eudaimonic dimension, as well as its exclusion of health items in the measure itself, distinguishes it from traditional HQoL measures, making it suitable for mental health and substance use disorder research.

QOL-22. USE OF TUMOR TREATING FIELDS THERAPY WITH ADJUVANT TEMOZOLOMIDE AND IMMUNOTHERAPY FOR NEW DIAGNOSED GLIOBLASTOMA (NDGBM)

Abstract BACKGROUND Treatment options for GBM remain limited, and novel approaches are required. One of them, Tumor Treating Fields (TTFields) therapy, is a non-invasive treatment modality that delivers low intensity, intermediate frequency, alternating electrical fields and increases survival through multiple mechanisms, including disrupting cell mitosis, triggering tumor cell death, and expanding CD8+ cytotoxic lymphocytes. METHODS In this prospective study, adult patients with ndGBM underwent standard-of-care treatment with maximal resection, followed by radiotherapy and temozolomide. Use of TTFields therapy, with a recommended daily use of ≥ 18 hours/day, throughout adjuvant temozolomide treatment and with immunotherapy, was investigated. RESULTS Eight patients received TTFields therapy. Use of TTFields was 2, 5, 6, 6, 8, 8, 10, and 16 months with an average of 10.2 months. The patient with the lowest use developed a grade 1 papulopustular scalp rash and discontinued use. Monthly average daily use ranged from 0% to 87%. Average daily use over treatment was 39%, 47%, 48%, 53%, 67%, 69%, 78%, and 83%. None of the patients achieved the goal for daily use every month. Four patients had a daily use ≥ 80% for at least one month of treatment. Except for one patient, whose daily use increased from 72% in the first month to 79% in the last month, all other patients down-trended in TTFields use. Six patients completed EORTC-QLQ-C30 surveys throughout the study. 3/8 had an overall increase in their global quality of life scale, 3 patients had a decrease, and 2 patients did not complete the survey. DISCUSSION In this study, the use of TTFields was suboptimal. We presume that with multiple treatments in the adjuvant phase including 6 cycles of temozolomide and optional TTFields use, patients did not recognize the potential therapeutic benefit of continued TTField therapy use and opted to remain only in the immunotherapy treatment.

Validation and adaptation of the Russian version colostomy impact score (CIS)

BACKGROUND: The number of people with intestinal stomas in Russia reaches 140 thousand people according to the registry of stoma patients. For any outcomes stoma on the anterior abdominal wall has an extremely negative effect on the body image and quality of life of this patient.AIM: Validation and cultural adaptation of the CIS questionnaire in the Russian Federation.MATERIALS AND METHODS: The official translation of the CIS questionnaire was performed according to current WHO and EORTC guidelines. The study involved 209 patients from 9 centers (3 national and 6 regional) from different districts of Russia.RESULTS: The stoma impact on quality-of-life questionnaire showed an inverse negative relationship with the EORTC QLQ-C30 global quality of life scale, physical, role, emotional and social functioning (all p&lt;0,05).CONCLUSION: The CIS Questionnaire reliably identifies a group of patients with a significant impairment in the quality of life and can be used in Russia.

Effect of Laparoscopic Sleeve Gastrectomy on Quality of Life.

The clinical benefits of bariatric surgery are well-established, but the impact of bariatric surgery on psychosocial outcomes such as health-related quality of life (HRQL) is less clear. The aim of this study is to assess the Quality of life (QOL) as a whole and in separate domains in post-bariatric surgery patients. A single unit cross-sectional analysis of a prospective study is done on QOL in 51 patients undergoing laparoscopic sleeve gastrectomy at tertiary hospital. QOL was assessed by WHOQOL-BREF (World Health Organisation Quality of Life questionnaire -Brief version) questionnaire and Global Quality of Life Scale in each patient. Scores were calculated on a 0-100 scale and results compared. The median scores given by patients before surgery were 14, 21, 42, 40 and 12.5 for each of the parameters physical, psychological, social, environmental and overall well-being respectively. The median scores for after surgery were 86, 87, 91, 88 and 87.5 respectively. The difference was significant (p value 0.001). Global QOL after surgery, calculated year wise, showed QOL scores of 90, 100, 95 and 80 in patients with 1year, 2years, 3years and 4years of follow-up without any significant difference (p value 0.502). Through this study, we emphasize the need for the selection of a standardised scale by international organisations to compare the different studies. By proving the significant differences in the QOL of patients who underwent LSG [laparoscopic sleeve gastrectomy], we suggest to consider the Quality of Life as one of the criteria to consider a patient for bariatric surgery.

Effect of Dual Task Training, Gait Training and Vestibular Rehabilitation on Balance and Quality of Life in Post Stroke Adults

OBJECTIVE: To investigate the effectiveness of dual task training, gait training and vestibular rehabilitation on balance and quality of life in post stroke adults. MATERIALS AND METHODS: This Pilot study was carried out on 45 post stroke participants both male and female who fulfilled the inclusion criteria were recruited for the study with age group between 40 to 60 years from out-patient physiotherapy department of Dr. M.G.R. Educational and Research Institute, Deemed to beUniversity. The subjects were randomly assigned into 3 groups, each group consisting of 15 subjects. Group A received dual task training for thrice a week of 45 minutes per session for 4 weeks. Group B received gait training program for thrice a week of 30 minutes per session for 6 weeks. Group C received Cawthorne and Cooksey exercises of vestibular rehabilitation for thrice a week of 60 minutes per session for 8 weeks. The outcome measures used were Global Quality of Life Scale (GQOL) and Berg Balance Scale (BBS). RESULT: When the mean values of GroupA, Group B and Group C were compared on GQOL and BBS scale revealed significant increase in the post test mean value with Group C showing 87 and 55 on GQOL and BBS respectively, which was higher than Group A mean values 84.1, 52.33 and followed by Group B mean value 80, 53.3 at p ≤ 0.001. Hence, Group C which received vestibular rehabilitation was more effective than other groups.

You Take the Low Road: Differential Outcomes After Tangential and Transcortical Approaches to Medial Temporal Brain Arteriovenous Malformations

Microsurgical resection of medial temporal brain arteriovenous malformations (AVMs) is typically conducted through 2 approaches: the orbitozygomatic-tangential and subtemporal-transcortical. Relative indications and outcomes for these techniques have not been formally compared. The cerebrovascular database of a quaternary center was reviewed for patients with medial temporal AVMs treated between January 1, 1997, and July 31, 2021. Demographic characteristics, lesion characteristics, surgical approaches, and outcomes were retrospectively analyzed and compared. Postoperative outcome testing was performed using the Montreal Cognitive Assessment and Global Quality of Life Scale. Fifty-nine patients were assessed. Mean (standard deviation) age was 31 (18) years; 30 (51%) patients were male. Of the AVMs, 29 (49%) were left-sided and 30 (51%) were right-sided. The tangential approach was selected in 20 (34%) cases, whereas the transcortical technique was preferred in 39 (66%). Improved modified Rankin Scale status was significantly associated with the tangential resection technique both in the early postoperative period (P= 0.02) and at last follow-up (P= 0.01). Differences between the tangential and transcortical approaches were not significant with respect to new postoperative deficits (5/20 [25%] vs. 12/39 [31%], P= 0.87) or the presence of residual AVM on follow-up angiography (1/20 [6%] vs. 5/39 [14%], P= 0.65). The orbitozygomatic-tangential strategy was associated with favorable functional and quality-of-life outcomes after medial temporal AVM resection. These benefits are likely to be attributable to minimization of temporal retraction, avoidance of brain transgression, and avoidance of traction on the vein of Labbé, rendering the orbitozygomatic-tangential approach the preferred option for cases that are anatomically amenable to either strategy.

Quality of Life in Patients Undergoing Double Umbilical Cord Blood Vs. Haploidentical Marrow Transplantation: A QOL Analysis Report of BMT CTN 1101

Introduction BMT CTN 1101 was a multicenter phase III randomized trial comparing the clinical outcomes and quality of life (QOL) of patients with hematological malignancies receiving double umbilical cord blood transplants (dUCBT) or haploidentical bone marrow transplants (haplo) with post-transplant cyclophosphamide after reduced intensity conditioning. Extended follow-up at 5 years showed that there were no significant differences in progression free survival (PFS) or overall survival (OS) between the two cohorts. However, the hazard ratio for NRM was 2.69 in favor of haplo transplants with all of the difference seen in the first 18 months post-transplant. The impact of donor source on QOL, however, is unknown. Thus, the objectives of this analysis are to compare longitudinal QOL between dUCBT and haplo and to investigate the association of QOL and clinical outcomes. Methods Enrollment occurred from 6/2012-6/2018, and included 368 patients (n=186 dUCBT, n=182 haplo), age 18-70 with 2 year follow up. QOL assessments included the FACT-BMT measure; the MOS Short Form 36 Physical Component Score (PCS) and Mental Component Score (MCS); the EQ-5D; and the Global QOL Scale. These were completed pre-transplant and at 12 and 24 months post-transplant. To account for missing assessments, scores were compared between arms using an inverse probability weighted-independent estimating equations (IPW-IEE) method that models scores in surviving patients while accounting for baseline variables (age, race/ethnicity, primary disease, disease risk, performance status, and HCT-CI) and follow-up outcomes that impact the likelihood of missingness. Cox models evaluated potential associations of pre-transplant QOL scores with OS and PFS while adjusting for these baseline variables. Analyses were performed using intention-to-treat (ITT) patient assignment from the time of randomization. A threshold of 1% was used to determine statistical significance for all analyses. Results No significant differences were observed between treatment arms in baseline patient, disease, and transplant characteristics (previously described) among patients who participated in at least one QOL assessment. In the UCB arm, PRO response rates were 145/186 (78%) pre-transplant, 67/105 (64%) at 12 months, and 47/85 (55%) at 24 months. In the haplo arm, PRO response rates were 134/182 (74%) pre-transplant, 79/115 (69%) at 12 months, and 50/102 (49%) at 24 months. HCT-CI >3 pre-transplant and relapse at 12 and 24 months were the most consistent factors significantly associated with lower completion of QOL questionnaires at respective time points. We found no significant difference in any of the QOL scores at pre-transplant, 12, and 24 months between the treatment arms (Figure 1). In multivariable IPW-IEE models, pre-transplant FACT-BMT total score, SF-36 PCS, and EQ-5D scores were the only significant predictors of post-transplant QOL scores. There was no significant association of treatment arm or baseline clinical variables with FACT-BMT or SF-36 PCS scores post-transplant. Age >60 was associated with higher mean EQ-5D (0.08, 99% CI 0.025-0.131, p=0.0002) and SF-36 MCS scores (4.45, 99% CI 0.288-8.622, p=0.0059) on post-transplant assessments. There was no significant impact of treatment arm on Global QOL score or subscale scores post-transplant. We evaluated the association of post-transplant clinical events with primary QOL endpoints (Table 1). Relapse and Grade III-IV aGVHD were associated with significant declines in mean FACT-BMT and SF-36 PCS scores. cGVHD was associated with a decline in mean EQ-5D utility scores. We found no significant association between pre-transplant QOL scores and OS or PFS (p>0.10 for all models). There were no significant interactions between treatment groups and baseline characteristics on QOL measures. Conclusions This longitudinal QOL analysis of BMT CTN 1101 showed that donor type did not impact post-transplant QOL. Pre-transplant QOL scores were the only predictor of post-transplant 12 and 24 month scores which, however, were not associated with OS or PFS in either treatment arm. Clinical events of GVHD and relapse were associated with declines in QOL scores. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Functional outcomes of transanal versus transabdominal restorative proctectomy with ileal pouch-anal anastomosis in ulcerative colitis-a monocentric retrospective comparative study.

Ileal pouch-anal anastomosis (IPAA) ensures satisfactory gastro-intestinal function and quality of life (QoL) in patients with refractory ulcerative colitis (UC). The transanal approach to proctectomy and IPAA (Ta-IPAA) has been developed to address the technical shortfalls of the traditional transabdominal approach (Tabd-IPAA). Ta-IPAA has proven to be safe but there is lack of reported functional outcomes. Aim of this study is to compare functional outcomes and QoL after Ta- or Tabd-IPAA for UC. This is a retrospective study of consecutive UC patients who underwent IPAA between 2011 and 2017, operated according to a modified 2- or 3-stage approach. Close rectal dissection was performed in Ta-IPAA as opposed to total mesorectal excision in Tabd-IPAA. A propensity score weighting was performed. Functional outcomes were assessed using the pouch functional score (PFS) and the Öresland score (OS). The global quality of life scale (GQOL) was used for patients' perspective on QoL. Follow-up was scheduled at 1, 3, 6, and 12months, postoperatively. One hundred and eight patients were included: 38 patients had Ta-IPAA. At 12months follow-up, mean OS and PFS were 4.6 (CI 3.2-6.0) vs 6.2 (CI 5.0-7.3), p = 0.025 and 6.1 (CI 3.5-8.8) vs 7.4 (CI 5.4-9.5), p = 0.32, for Ta and Tabd-IPAA, respectively. Mean GQOL for Ta-IPAA was 82.5 (CI 74.8-90.1) vs 75.5 (69.4-81.7) for Tabd-IPAA (p = 0.045). At 12months postoperatively, pouch function and QoL of Ta-IPAA are probably as good as those of Tabd-IPAA. Limitations include retrospectivity, differences in the surgical technique, and lack of validated scores for QoL.

The association between acne care provision and quality of life: A cross-sectional survey.

Background and AimsIt has been suggested that professional acne care can be effective not only in reducing clinical signs but also in improving quality of life (QOL). This study aims to reach a better understanding of the association between QOL and professional acne care. The study also investigates other factors that might influence QOL such as age, gender, and acne severity.MethodsBetween 2019 and 2020, a cross‐sectional survey‐based study was conducted among 362 acne patients. Data were collected by the Cardiff Acne Disability Index (CADI) and a Global QOL scale. Analysis of covariance (ANCOVA) and post hoc comparisons were conducted to analyze the association between professional acne care and health‐related QOL.ResultsNo statistically significant differences were found in QOL measured by CADI among patients visiting the four investigated acne caregivers (mean CADI score: dermatologist, 4.49; GPs, 4.42; dermal therapist, 4.07; beautician, 4.20, P = .24). However, the impact of the treatment on the QOL, which was measured by the level of Global QOL improvement before and after care, demonstrated a statistically significant improvement when attending a dermatologist, compared to the care provided by beauticians (Global QOL improvement: dermatologist, 1.50; GP, 1.01; dermal therapist, 1.10; beautician, 0.54, P = .05). Females experienced a more impaired acne‐related QOL than males (P = .05), and increased acne severity was associated with a more impaired QOL (P < .05).ConclusionsThis study delineated factors that influence QOL in acne patients. As the QOL was not associated with the type of caregiver, the greatest QOL improvement before and after care was achieved after medical treatment by the dermatologist. Females and individuals dealing with more severe types of acne experienced a more impaired acne‐related QOL. It is recommended to take these factors into account in acne management to optimize professional treatment in line with patient needs.

P167 Functional outcomes of transanal versus transabdominal proctectomy with ileal pouch-anal anastomosis in Ulcerative Colitis. A comparative study

Abstract Background This study aimed at comparing functional outcomes and quality of life (QoL) after transanal and transabdominal approach for ileal-pouch surgery in ulcerative colitis (UC)Ileal-pouch surgery ensures satisfactory intestinal function and QoL. The transanal ileal pouch-anal anastomisis (Ta-IPAA) has recently been developed in the effort to address the technical shortfalls of the traditional transabdominal approach (Tabd-IPAA). According to previous studies, Ta-IPAA is safe. However, functional outcomes after ta-IPAA are scarcely described. Methods This is a retrospective study of consecutive UC patients who underwent IPAA from 2011 to 2017. Only patients operated according to a modified-2 or 3 stage approach were included in the analysis. Close rectal dissection was systematically performed in Ta-IPAA as opposed to total mesorectal excision in Tabd-IPAA. Groups were compared after propensity score weighting. Functional outcomes were assessed using two functional scoring systems: the Pouch Functional Score (PFS) and the Öresland score (OS). The global quality of life scale (GQOL) was used for patients’ overall perspective on QoL. Follow-up was scheduled at 1, 3, 6, and 12 months postoperatively. Results One hundred and nine patients were included. Of them, 38 patients underwent Ta-IPAA. At 12 months follow-up, mean OS and PFS were 4.6 (CI 3.2–6.0) vs 6.2 (CI 5.0–7.3), p=0.02 and 6.1 (CI 3.5–8.8) vs 7.4 (CI 5.4–9.5), p=0.32, for Ta and Tabd-IPAA, respectively. Mean GQOL score for Ta-IPAA was 82.7 (CI 75.1–90.2) vs 75.5 (69.4–81.6) for Tabd-IPAA (p=0.038). Conclusion Transanal IPAA provides better functional results and QoL scores than Tabd-IPAA in UC patients.

Quality of life improvement in patients with hard-to-heal leg wounds treated with Prontosan wound irrigation solution and wound gel.

This study evaluated the impact of four weeks of treatment with Prontosan Wound Irrigation Solution and Prontosan Wound Gel (B. Braun Medical Inc., US) on adults with hard-to-heal leg wounds. Overall change (weeks 1-5) in the Global Quality of Life scale (GQOL), changes in body, psyche and everyday life (EDL) quality of life (QoL) subscores, and changes in wound appearance and size after treatment were assessed. In this prospective, open-label, single-arm, five-centre study, non-hospitalised patients with no more than two wounds below the knee were recruited into the study; wounds were ≥5cm2 and ≤50cm2 and present for ≥4 weeks. The investigator or a designee applied the wound solution and gel to the wounds at clinic visits, and patients/caregivers applied the wound solution and gel at home. Wound-QoL questionnaires were completed at the initial screening and at each week of treatment. Wound size and photographs were obtained at pre- and post-treatment during clinic visits. A total of 43 patients were enrolled in the study. Mean GQOL scores decreased by 1.11 (46.1%). Body, psyche and EDL decreased by 1.17 (60.0%), 1.26 (41.8%) and 1.00 (42.2%), respectively. Wounds also showed improvement in odour, appearance and size. Adverse events were mild in intensity and transient in nature. This study demonstrated marked improvement in the QoL of patients with hard-to-heal leg wounds below the knee during four weeks of treatment with the wound solution and gel. Wounds also showed improvement in odour, appearance and size, and the treatment solution and gel were well tolerated. B. Braun Medical Inc. funded the research and preparation of this article. AK, DV, CRC and WC are employees of B. Braun Medical Inc. AO and RS declare no conflict of interest.

Usefulness of Smartphone Apps for Improving Nutritional Status of Pancreatic Cancer Patients: Randomized Controlled Trial.

BackgroundApproximately 80% of pancreatic ductal adenocarcinoma (PDAC) patients suffer from anorexia, weight loss, and asthenia. Most PDAC patients receive chemotherapy, which often worsens their nutritional status owing to the adverse effects of chemotherapy. Malnutrition of PDAC patients is known to be associated with poor prognosis; therefore, nutritional management during chemotherapy is a key factor influencing the outcome of the treatment. Mobile apps have the potential to provide readily accessible nutritional support for patients with PDAC.ObjectiveWe aimed to evaluate the efficacy of a mobile app–based program, Noom, in patients receiving chemotherapy for PDAC.MethodsWe prospectively enrolled 40 patients who were newly diagnosed with unresectable PDAC from a single university-affiliated hospital in South Korea, and randomly assigned them into a Noom user group (n=20) and a non-Noom user group (n=20). The 12-week in-app interventions included meal and physical activity logging as well as nutritional education feedback from dietitians. The non-Noom user group did not receive any nutrition intervention. The primary outcomes were the changes in the nutritional status and quality of life (QoL) from the baseline to 12 weeks. The secondary outcomes included the changes in the skeletal muscle index (SMI) from the baseline to 12 weeks. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) and the Patient-Generated Subjective Global Assessment (PG-SGA) were used as paper questionnaires to assess the QoL and nutritional status of the patients. Intention-to-treat and per-protocol analyses were conducted. Regarding the study data collection time points, we assessed the nutritional status and QoL at the baseline (T0), and at 4 (T1), 8 (T2), and 12 (T3) weeks. Abdominal computed tomography (CT) imaging was conducted at the baseline and after 8 weeks for tumor response and SMI evaluation. The skeletal muscle area (cm2) was calculated using routine CT images. The cross-sectional areas (cm2) of the L3 skeletal muscles were analyzed.ResultsBetween February 2017 and January 2018, 48 patients were assessed for eligibility. Totally 40 patients with pancreatic cancer were included by random allocation. Only 17 participants in the Noom user group and 16 in the non-Noom user group completed all follow-ups. All the study participants showed a significant improvement in the nutritional status according to the PG-SGA score regardless of Noom app usage. Noom users showed statistically significant improvements on the global health status (GHS) and QoL scales compared to non-Noom users, based on the EORTC QLQ (P=.004). The SMI decreased in both groups during chemotherapy (Noom users, 49.08±12.27 cm2/m2 to 46.08±10.55 cm2/m2; non-Noom users, 50.60±9.05 cm2/m2 to 42.97±8.12 cm2/m2). The decrement was higher in the non-Noom user group than in the Noom user group, but it was not statistically significant (-13.96% vs. -3.27%; P=.11).ConclusionsThis pilot study demonstrates that a mobile app–based approach is beneficial for nutritional and psychological support for PDAC patients receiving chemotherapy.Trial RegistrationClinicalTrials.gov NCT04109495; https://clinicaltrials.gov/ct2/show/NCT04109495.

Prophylaxis with ATLG Significantly Improves Chronic Graft-Versus-Host Disease / Relapse-Free Survival and Quality of Life after a Myeloablative HLA Identical Sibling Transplant for Acute Leukemia Patients in Complete Remission. Long-Term Follow-up of the Randomized ATG Familystudy

IntroductionChronic GVHD is a major complication after allogeneic stem cell transplantation (HSCT) affecting both survival and quality of life (QoL). Several strategies are currently used to limit the incidence and severity of GVHD. All but one prospective randomized studies demonstrated in the unrelated and related settings a significant reduction of cGVHD when anti-T cell lymphocyte globulin (ATLG) or anti-thymocyte globulin (ATG) is added to the standard GVHD prophylaxis (cyclosporine and methotrexate) with significant improvement of survival free from relapse and cGVHD (cGRFS), similar overall survival and no increase of relapse risk. In the setting of sibling transplants, the ATGfamilystudy demonstrated that in acute leukemia patients in complete remission the addition of ATLG (Grafalon, NEOVII) at the dose of 10 mg/kg per day from day -3 to day -1 to the standard GVHD prophylaxis within a myeloablative conditioning regimen resulted in a significant reduction of cGVHD (68.7% vs 32.2% at two years), especially of the extensive form (52.4% vs 7.6%) without a significant increase of relapse, infection and non relapse mortality (NRM). Overall survival resulted similar in the two arms while cGRFS was significantly improved (37% vs 16.7%). The risk of relapse is claimed as the major concern for a broader adoption of ATLG in the GVHD prophylaxis and a longer follow-up is strongly claimed by the scientific community to definitely unravel the issue of disease recurrence after in vivo T cell depletion with ATLG.MethodsWe updated the follow-up of the trial NCT 00612875 (Kröger et al. NEJM 2016) and analyzed data of QoL. The primary endpoint was the CI of cGVHD. CI of cGVHD, NRM, relapse, overall survival, disease-free survival and chronic GVHD and relapse-free survival (cGRFS) were analysed. The trial included also quality of life (QoL) questionnaires (EORTC QLQ-30 and HDC29 ) before and after SCT. The QLQ-C30 includes a global QoL scale, 5 functional scales (physical, role, emotional, cognitive and social function) and 9 symptom scales (fatigue, nausea-vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial problems).ResultsOut of 155 patients analyzed for safety and efficacy in the randomized study 119 were still alive at study end after 2 years and 114 provided any follow-up data. The median observation time was 5.2 and 6.0 years, in the experimental and control arm, respectively, with a maximum follow-up time >10 years in both groups.The CI of cGVHD overall was 31.3% (95% CI: 22.6% - 43.3%) in the ATLG arm vs 69.1% (95% CI: 59.1% - 80.7%) in the control arm (p <0.001); the CI of relapse was 36.6% (95% CI: 27.5% - 48.7%) and 23.9% (95% CI: 15.8% - 36.2%, p = 0.09). 5-ys overall survival, disease-free survival and cGRFS in the experimental and control arm were 61.8% and 67.1% (p=0.564), 53.6% and 61.7% (p=0.364), 40.4% and 18.1% (p = 0.001), respectively.Patients who received ATLG showed significantly greater improvement of global health status / QoL over time compared to non-ATLG (p=0.02), with a difference between the two arms of 2.8 ± 3.9 points (marginal mean ± SEM) at day 100 and increasing to 10.5 ± 5.3 points at month 24 in favour of ATG. Patients in the ATG arm showed also a significant superiority in 4 of the 5 functional scales as well as for several symptom scales scores such as appetite loss, insomnia, nausea-vomiting and dyspnea. For the QLQ-HDC29, significant treatment effects favoring ATG were observed for side-effects on gastrointestinal effects and impact on family, impact of family, urinary frequency, helping to distinguish what is important in life.ConclusionsThis long-term follow-up of the ATGfamilystudy confirmed a significant benefit of ATLG in reducing chronic GVHD without significant increase of relapse in patients with acute leukemia undergoing HLA-identical sibling allogeneic peripheral stem cell transplantation resulting in a significant benefit in chronic GVHD/relapse-free survival with a significant improved quality of life. DisclosuresBonifazi:Neovii: Honoraria. Solano:Neovii: Honoraria. Bethge:Neovii GmbH: Honoraria, Research Funding; Miltenyi Biotech GmbH: Consultancy, Honoraria, Research Funding. Kroeger:Neovii: Honoraria, Research Funding.

Real-world quality of life (QoL) in black, indigenous and people of color (BIPOC) treated with palbociclib (PAL) and endocrine therapy for hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer (ABC): A subgroup analysis from POLARIS.

1071 Background: Racial disparities in breast cancer incidence, mortality, and care are well documented. PAL plus endocrine therapy is indicated for patients (pts) with HR+/HER2− ABC. Findings from the PALOMA clinical trials have shown that pts receiving PAL maintained stable QoL; however, limited QoL data are available from real-world settings for BIPOC receiving PAL. Methods: POLARIS is a noninterventional, prospective, primarily US-based study in pts with HR+/HER2– ABC receiving PAL. QoL was assessed with the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) at baseline, monthly for the first 3 mo of treatment (Tx) with PAL, and then every 3 mo. In this interim analysis, we report Tx patterns and QoL assessments at baseline and at 6 mo and 12 mo in BIPOC from POLARIS. Results: Of 1280 pts treated with PAL as November 10, 2020, 233 were included in the BIPOC subgroup of whom 159 (68.2%) completed PAL Tx for ≥6 mo and 112 (48.1%) for ≥12 mo. In the BIPOC cohort, 59.2% of pts were black, 35.2% Hispanic, 3.4% American Indian or Alaskan native, 2.1% Pacific Islander. PAL in combination with letrozole/anastrozole was received by 116 pts, 94 received PAL plus fulvestrant, 13 received PAL plus exemestane, and 10 received PAL plus another Tx; 175 pts (75.1%) received PAL as first-line Tx. Mean EORTC QLQ-C30 global health QoL and functional scales scores remained stable over the first 12 mo of PAL Tx, without any changes at or above the 10-point threshold considered clinically meaningful, and were similar to those previously reported in an earlier analysis of the entire POLARIS population (Table and Rocque et al SABCS 2019). Symptom scales scores, including nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, and diarrhea, also remained stable over 12 mo. Conclusions: In this subgroup analysis, PAL had no significant adverse impact on QOL in BIPOC with HR+/HER2– ABC, consistent with previous findings from the total POLARIS study population. Pfizer (NCT03280303). Clinical trial information: NCT03280303 .[Table: see text]

Pre-Treatment Health-Related Quality of Life Parameters May Have Prognostic Impact in Elderly Patients with Mantle Cell Lymphoma. the Nordic Lymphoma Group MCL4 (LENA-BERIT) Experience

Background: Mantle cell lymphoma (MCL) is a rare, often aggressive type of B-cell lymphoma with poor survival and no cure. Cancer and cancer treatment has a negative impact on health-related quality of life (HRQOL) both during active disease and in the long term, and improvement of HRQOL may be one of the most important objectives of cancer therapy. In addition, baseline HRQOL has in other lymphoma populations been shown to be predictive of outcome. Hitherto, there are only few reports on HRQOL in MCL. The primary aim of this study was to explore HRQOL before, during and after chemotherapy in an elderly population with MCL. Secondary aims were to identify predictors for HRQOL, information that can be used for improvement in rehabilitation. Methods: The cohort consisted of patients included in the multicenter open-label phase Ib-II NLG-MCL4 trial (LENA-BERIT), designed to evaluate the addition of lenalidomide (LEN) to rituximab-bendamustine (R-B) as first-line treatment in elderly patients (&amp;gt;65 years) with MCL. The treatment with R-B stopped after six months, LEN continued for six more months. HRQOL was assessed by the EORTC QLQ-C30 questionnaire pre-treatment, and after 6, 12 and 24 months post study inclusion. For the functional scales and the global quality of life scale a higher score represents a better level of functioning. For the symtom scales and single items, a higher score corresponds to a higher level of symtoms. Patient scores were compared to scores from a reference population sample at baseline. Survival was analysed by Kaplan-Meier estimates, and cox regression multivariate analysis was used to assess survival with adjustments for prognostic factors, age, sex and more. Results: Fifty-one patients were enrolled, 1 patient was excluded based on screen failure. Median age was 71 years (range 62-84), 37 were men (73%). Stratified according to Mantle Cell Lymphoma International Prognostic Index (MIPI), 5 (10%) were low-risk, 18 (38%) intermediate and 26 (52%) high-risk. Follow-up time for living patients were 52 months, and for deceased patients 27 months. Median overall survival time were 52 months. The proportion of patients reporting HRQOL data was at baseline; 48 (96%), after 6 months; 33 (83%), after 12 months; 27 (89%), and after 24 months; 12 (75%). During the first six months of treatment, several functional scores deteriorated, and after 12 months it had stabilised at baseline level or better. The global health status (QoL) improved at 12 months after diagnosis, but then dropped to baseline levels after 2 years. Before treatment, patients exhibited levels of the symptom scores, comparable to the reference population. Six months after start of therapy, the scores for pain, dyspnoea and insomnia were improved, while appetite loss and diarrhoea were impaired. After 12 months, the symptom scales improved to a level superior compared both to baseline and the reference population. The population was divided into two groups, with the median as cut-off values. In the multivariate analysis, including MIPI, gender and the presence of TP53 mutation, impaired pre-treatment physical function, role function and elevated pain score were independent prognostic markers for overall survival. Role function and pain were also independent prognostic markers for progression free survival. Conclusion: In this population of elderly patients with MCL, pre-treatment HRQOL was similar to the reference population. During treatment, HRQOL deteriorated, but reverted to the same level as the reference population after treatment. Pre-treatment physical and role function and pain were independent factors associated with overall survival. These novel findings may be used to design support during treatment and improve rehabilitation. Figure Disclosures Jerkeman: Roche: Research Funding; Celgene: Research Funding; Janssen: Research Funding; Gilead: Research Funding; Abbvie: Research Funding.

Ileal pouch–anal anastomosis in ulcerative colitis: outcomes, functional results, and quality of life in patients with more than 10-year follow-up

Ileal pouch-anal anastomosis (IPAA) has become the surgical procedure of choice for patients with ulcerative colitis (UC). IPAA was incorporated into our institution in 1984, and thereafter, more than 200 procedures have been performed. The functional results and morbidity of this surgery have been reported previously. However, long-term functional outcomes and quality of life have not been evaluated. As a cohort study, we identified all consecutive patients who underwent IPAA for UC between 1984 and 2017 and selected those with more than 10-year follow-up. Demographic data, morbidity, and pouch survival information were obtained. Long-term functional results and quality of life were evaluated through an e-mail survey using the Öresland score and the Cleveland Global Quality of Life scales, respectively. Of 201 patients, 116 met the inclusion criteria. Median follow-up was 20 (10-34) years. Early post-operative complications (30days) were observed in 19 (16.4%) patients and 66 (56.9%) presented adverse events. The IPAA preservation rate at 10 and 20years was 96.5% and 93.1%, respectively. Long-term functional scores presented a median of 6 (1-15) points. IPAA function was satisfactory in 11 (20.0%) patients, acceptable in 18 (32.7%), and deficient in 26 (47.3%). The median score for global quality of life was 0.8 (0.23-1.0) points. IPAA as treatment for UC meets the expectations of cure of the disease, maintaining adequate long-term intestinal functionality associated with a good quality of life in most patients.