Changes In QoL Research Articles

Factors associated with greater health-related quality of life benefits in people with hATTR amyloidosis with polyneuropathy treated with

Hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN) is a genetic condition that shortens lifespan and carries significant morbidity. We aimed to identify factors associated with greater benefits from inotersen, measured by changes in Norfolk QOL–DN total score (TQOL, score range − 4 to 136, higher scores indicating poorer QOL).

CLRM-14. OPEN-LABEL, MULTINATIONAL, MULTICENTER, PHASE 3B/4 STUDY OF TRASTUZUMAB DERUXTECAN (T-DXD) IN PATIENTS WITH OR WITHOUT BASELINE BRAIN METASTASIS (BM) WITH PREVIOUSLY TREATED ADVANCED/METASTATIC HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2–POSITIVE BREAST CANCER (HER2+ BC): DESTINY-BREAST12

Abstract BACKGROUND Despite treatment advances, up to 50% of patients with advanced HER2+ BC develop BM (Zimmer. Cancer Rep. 2020). Patients with HER2+ BC with BM have a worse prognosis than patients without BM. In DESTINY-Breast01, T-DXd demonstrated efficacy in the overall population and preliminary efficacy in a subgroup with stable BM, with a confirmed objective response rate (ORR) of 61.4% and an extracranial confirmed ORR by independent central review (ICR) of 58.3%, median progression-free survival (PFS) of 19.4 and 18.1 mo, and median duration of response (DOR) of 20.8 and 16.9 mo (Modi. Cancer Res. 2021; Jerusalem. Ann Oncol. 2020). Here we describe a trial evaluating T-DXd in patients with previously treated advanced/metastatic HER2+ BC ±BM. DESIGN DESTINY-Breast12 (NCT04739761) is an open-label, multicenter, international (86 sites in the US, Europe, Australia, and Japan), phase 3b/4 study assessing T-DXd 5.4 mg/kg q3w efficacy and safety in patients with previously treated advanced/metastatic HER2+ BC ±BM that progressed with ≥1 prior anti-HER2–based regimen and received ≤2 lines of therapy in the metastatic setting (excluding patients with prior tucatinib). Patients (n=250/cohort) will be enrolled in cohort 1 (−BM at baseline) or 2 (+BM at baseline). BM must be untreated and not needing immediate local therapy or previously treated and stable or progressing. Primary endpoints are ORR (cohort 1) and PFS (cohort 2) (both by RECIST version 1.1 per ICR). Secondary endpoints are OS, DOR, time to progression, duration of subsequent therapy, PFS2, safety, and changes in symptoms, functioning, and QOL in both cohorts; incidence of new symptomatic CNS metastasis (CNSM) in cohort 1; and ORR and CNS ORR by RECIST 1.1 per ICR, CNS PFS and DOR, and time to new CNSM in cohort 2. This is an encore; the original presentation will be at The European Society for Medical Oncology 2021.

MP01-14 XPEEDA TM HOLMIUM LASER VAPORESECTION VS GREENLIGHT XPS TM VAPORIZATION OF THE PROSTATE: RESULTS FROM A RANDOMIZED CONTROLLED TRIAL

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology I (MP01)1 Sep 2021MP01-14 XPEEDATM HOLMIUM LASER VAPORESECTION VS GREENLIGHT XPSTM VAPORIZATION OF THE PROSTATE: RESULTS FROM A RANDOMIZED CONTROLLED TRIAL Hazem Elmansy, Waleed Shabana, Abdulrahman Ahmad, Fabiola Oquendo, Amr Hodhod, Loay Abbas, Ryan Kelly, Shalyn Littlefield, Ahmed Kotb, and Walid Shahrour Hazem ElmansyHazem Elmansy More articles by this author , Waleed ShabanaWaleed Shabana More articles by this author , Abdulrahman AhmadAbdulrahman Ahmad More articles by this author , Fabiola OquendoFabiola Oquendo More articles by this author , Amr HodhodAmr Hodhod More articles by this author , Loay AbbasLoay Abbas More articles by this author , Ryan KellyRyan Kelly More articles by this author , Shalyn LittlefieldShalyn Littlefield More articles by this author , Ahmed KotbAhmed Kotb More articles by this author , and Walid ShahrourWalid Shahrour More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001962.14AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To compare the safety and efficacy of Holmium Laser XpeedaTM Vaporesection and GreenLight XPSTM Vaporization of the Prostate in patients with prostate glands ≤80 g METHODS: Eighty-six men with benign prostatic hyperplasia (BPH) and prostate glands ≤80 g scheduled for laser prostatectomy were included in this prospective randomized trial. Outcome measures including IPSS, QoL, flow rate, PVR, IIEF-15, ICIQ-SF, PSA, catheterization time, and TRUS prostate volume changes were collected and compared. Perioperative complications were also recorded. Patients were offered a trial of void (TOV) 3 hours after their procedures. All patients were discharged home on the same day and were followed up at 1, 3, and 6 months. RESULTS: There were no significant differences in preoperative baseline data between the two surgical groups. Successful same day TOV was noted in 72.2% and 72% of the XpeedaTM and GreenLight XPSTM patients, respectively p=0.98. The laser energy used was significantly lower in XpeedaTM group p=0.002. There were no significant differences in functional and sexual outcomes between both groups at 6 months. Operative parameters and postoperative outcomes are shown in Table 1. CONCLUSIONS: Holmium Laser Xpeeda™ Vaporesection and GreenLight XPSTM Vaporization are safe and effective in the treatment of BPH. Same-day discharge with early trial of void is a feasible option. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e6-e6 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hazem Elmansy More articles by this author Waleed Shabana More articles by this author Abdulrahman Ahmad More articles by this author Fabiola Oquendo More articles by this author Amr Hodhod More articles by this author Loay Abbas More articles by this author Ryan Kelly More articles by this author Shalyn Littlefield More articles by this author Ahmed Kotb More articles by this author Walid Shahrour More articles by this author Expand All Advertisement Loading ...

The quality of life in patients with coronary artery disease before and after revascularizatoin

Background and Aims: The aim of the study was to compare the changes of the values of QoL in patients with stable coronary artery disease and preserved LVEF within 6 months after revascularization interventions (CABG or PCI) and to identify the factors that may affect QoL changes.

Determining the Minimal Important Difference for the Wound-QoL Questionnaire.

BackgroundThe questionnaire for the quality of life with chronic wounds (Wound-QoL) is a valid and reliable instrument to determine the disease-specific health-related QoL of patients with chronic wounds. For the interpretation of HRQoL scores, it is additionally important to know which differences in scores are considered meaningful. The minimal important difference (MID) is defined as a change in HRQoL that a patient would consider meaningful, such that the patient would judge a treatment to be beneficial and worthy of repeating.ObjectiveTo interpret changes in the Wound-QoL scores and draw conclusions regarding the relevance of detected changes; the purpose of this study was to estimate the MID of the Wound-QoL global score and its subscales for patients with chronic wounds.Patients and MethodsPatients completed the Wound-QoL before and four to six weeks after treatment and additionally gave a global rating of wound status change after treatment. The global rating of change served as an anchor question. MIDs were calculated based on an anchor-based and a distribution-based method.ResultsIn total, 227 patients participated in the study. The mean age of the study population was 66.9 (± 12.7) median was 69.5, and 51.5% of the patients were female. MIDs for the Wound-QoL global score ranged from 0.47 to 0.52, proposing an overall estimation of 0.50.ConclusionThe results can be used to measure and interpret changes in wound-specific QoL over time.

84-OR: Semaglutide 2.4 mg Improves Health-Related Quality of Life in Adults with Overweight/Obesity and Type 2 Diabetes in the STEP 2 Trial

Effects of s.c. semaglutide 2.4 mg vs. placebo on health-related quality of life (HRQoL) were evaluated in the STEP 2 trial in adults with overweight/obesity and T2D. The STEP 2 trial was an RCT in adults with BMI ≥27 kg/m2 and T2D (NCT03552757). Patients were randomized 1:1:1 to 68 weeks’ once-weekly semaglutide 2.4 mg (N=404), 1.0 mg (N=403; results not shown), or placebo (N=403), plus lifestyle intervention. Changes in scores at week 68, and achievement of clinically meaningful within-person improvements (see Table for meaningful change thresholds), in weight-related QoL (Impact of Weight on Quality of Life-Lite Clinical Trials Version [IWQoL-Lite-CT]) and HRQoL (SF-36v2® Health Survey acute version [SF-36]) were assessed. Body weight change at week 68 with semaglutide 2.4 mg vs. placebo was -9.6% vs. -3.4%. Changes in IWQoL-Lite-CT scores and SF-36 scores (except role-emotional) were consistently in favor of semaglutide vs. placebo (Table). The proportions of patients with clinically meaningful improvements was greater with semaglutide vs. placebo for all IWQoL-Lite-CT scores and SF-36 physical functioning score (Table). In adults with overweight/obesity and T2D, semaglutide 2.4 mg improved both physical and mental health components vs. placebo and led to greater proportions of patients with clinically meaningful changes in weight-related QoL and physical functioning. Disclosure D. Rubino: Advisory Panel; Self; Novo Nordisk, Other Relationship; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk, Speaker’s Bureau; Self; Novo Nordisk, Stock/Shareholder; Self; Novo Nordisk. L. Faerch: Employee; Self; Novo Nordisk A/S, Stock/Shareholder; Self; Novo Nordisk A/S. H. H. Meincke: Employee; Self; Novo Nordisk A/S. R. F. Kushner: Advisory Panel; Self; Novo Nordisk A/S. S. Pedersen: Advisory Panel; Self; AstraZeneca, Bausch and Lomb Incorporated, Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, HLS Therapeutics Inc., Janssen Global Services, LLC., Novo Nordisk, Consultant; Self; Abbott, Research Support; Self; AstraZeneca, Eli Lilly and Company, Novo Nordisk, Pfizer Inc., Speaker’s Bureau; Self; Abbott Laboratories, AstraZeneca, Bausch and Lomb Incorporated, Bayer Inc., Boehringer Ingelheim (Canada) Ltd., Dexcom, Inc., Eli Lilly and Company, HLS Therapeutics Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk, Sanofi. D. H. Ryan: Advisory Panel; Self; Alyvent, Naturally Slim, Epitommee,, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Global Services, LLC., Pfizer Inc., Redesign Health, Inc., Sanofi, Consultant; Self; Bausch Health, Canada, Phenomix, Xeno Bioscience, Gila Therapeutics, Scientific Intake, UnitedHealth Group, Other Relationship; Self; Novo Nordisk Inc. S. Wharton: Advisory Panel; Self; Novo Nordisk A/S, Novo Nordisk Canada Inc., Speaker’s Bureau; Self; AstraZeneca, Bausch Health, Canada, Novo Nordisk, Novo Nordisk Canada Inc. N. Zeuthen: Employee; Self; Novo Nordisk, Stock/Shareholder; Self; Novo Nordisk. R. Kolotkin: Consultant; Self; Novo Nordisk, Other Relationship; Self; Rhythm Pharmaceuticals, Inc. Funding Novo Nordisk A/S

Therapeutic efficacy of 225Ac-PSMA-617 targeted alpha therapy in patients of metastatic castrate resistant prostate cancer after taxane-based chemotherapy.

225Ac-PSMA-617 therapy has shown good response in many recent studies. We report our experience of targeted alpha therapy with 225Ac-PSMA-617 in mCRPC patients who have failed therapy with taxanes. Thirty-eight patients with CRPC with progressive disease following at least one taxane-based chemotherapy received 225Ac-PSMA-617 between July 2017 and Nov 2019. Primary end point was a composite 50% PSA and radiological response. Secondary endpoints were PFS, OS, and changes in QOL. The differences in outcomes between patients with skeletal and lymph-node metastases versus those with visceral metastases were also studied. A composite response by predetermined criteria was observed in 25 (66%) of 38 patients. The median PFS was 8months (95% CI 5.3-10.6months). Median overall survival was 12months (95% CI 9.1-14.9) with 16 patients alive at the time of censorship. There was no difference in response rates or survival statistics between patients with visceral metastases versus those with only bone and lymph-node metastases (Chi-square 1.51, df 1, Sig 0.218). The most common adverse effect was xerostomia. On the QOL Symptom score, Pain, Fatigue Insomnia, and constipation showed a significant improvement as compared to baseline. 225Ac-PSMA-617 is a safe and tolerable treatment option for mCRPC that demonstrates marked anti-tumour activity with improvement in quality of life even in patients of metastatic CRPC who have been previously treated with taxane-based chemotherapy.

Voiding and Storage Domain-Specific Symptom Score Outcomes After Prostate Artery Embolization for Lower Urinary Tract Symptoms and Urinary Retention

ObjectiveTo characterize voiding and storage symptom domain-specific outcomes after prostate artery embolization (PAE) to treat lower urinary tract symptoms (LUTS) or urinary retention caused by benign prostatic hyperplasia (BPH). MethodsTwo hundred forty patients (age = 74.5 ± 8.6 years) underwent PAE between May 2013 and March 2020 at a single center for LUTS (n = 161) or urinary retention (n = 79). Total International Prostate Symptom Score (IPSS-t), voiding domain score (IPSS-v), storage domain score (IPSS-s), and Quality of Life score (QoL) were obtained pre-PAE for LUTS patients (IPSS-t = 21.7 ± 6.2, IPSS-v = 11.9 ± 4.3, IPSS-s = 9.6 ± 3.1, QoL = 4.5 ± 1.2), and post-PAE through 36 months (mean = 22.9 ± 15.2 months) for LUTS and retention patients. Mean relative changes in IPSS-t, IPSS-v, IPSS-s, and QoL were calculated for LUTS patients. Mean voiding or storage component scores were calculated for retention patients. ResultsFor evaluable LUTS patients (n = 147), IPSS-t showed sustained substantial improvement through 36 months (6.3 ± 4.2-8.6 ± 7.6), as did QoL (1.1 ± 1.1-1.8 ± 1.5). One month after PAE, improvements in IPSS-v (69% ± 29%) were greater than in IPSS-s (46% ± 33%; P < .000001), and remained so through 36 months (68% ± 31% vs 53% ± 28%, P = .004). Among evaluable retention patients (n = 75), 84% passed voiding trials. Both IPSS-t (6.0 ± 3.9-8.2 ± 6.7) and QoL (0.9 ± 1.2-1.5 ± 1.6) remained low through 36 months. One month after PAE, mean IPSS-v component score (0.9 ± 1.3) was lower than mean IPSS-s component score (1.7 ± 1.4; P = .003) and remained so through 24 months (0.9 ± 1.2 vs 1.3 ± 1.1, P = .02), with similar trend at 36 months (0.7 ± 1.1 vs 1.1 ± 1.1, P = .07). ConclusionsPAE effectively treated BPH-related LUTS and retention. IPSS-v improved more than IPSS-s in LUTS patients, and remained lower in LUTS and retention patients through 36 months.

The Relevance of Assessing Subjective Experiences of Skin Toxicity During Adjuvant Radiotherapy for Breast Cancer.

PurposeRadiodermatitis is likely to be an inevitable side effect of radiotherapy (RT) but experiencing pain relief during RT might contribute making treatment more acceptable and less impairing. The current study aimed to assess the subjective perceptions and experiences of skin toxicity in a sample of women undergoing adjuvant RT for breast cancer.MethodsEighty patients were randomly assigned to one out of two groups: treatment (i.e., a newly developed topical product) and control (i.e., standard-of-care). Patients underwent adjuvant RT for 3 weeks. Clinical assessment of radiodermatitis and self-reported levels of pain, relief, and perceptions of treatment response were collected at the initiation of RT (T1), during RT (T2 and T3), and 2 weeks after treatment completion (T4). To assess changes in skin-related QoL, a subgroup of patients completed the Padua Skin-Related QoL questionnaire at T0 (before the initiation of RT) and at T4.ResultsA comparable timing of onset and severity of radiodermatitis during treatment was observed in both groups. The treatment group reported lower levels of pain and higher levels of relief compared to the control group when skin toxicity was at its highest levels (T2 and T3). Independent of the group, levels of perceived improvements in clinical status increased over time, whereas skin-related QoL worsened from T0 to T4.ConclusionCurrent findings outline the relevance of integrating clinical evaluations of radiodermatitis with patients’ subjective experiences of skin toxicity in interventional studies. Moreover, they provide preliminary evidence about the soothing effect of a newly developed topical product, thus supporting its usefulness of as a supportive care.

Postoperative health-related quality of life of patients with gynecological malignancy: a meta-analysis.

We sought to describe the short-term (1, 3, 6, 12 months) QoL changes after surgery for patients with gynecological malignancies in a meta-analysis. We collected studies based on the PICOS (patients, intervention, comparison, outcome, and study design) framework (P: patients with gynecological malignancy; I: surgery; C: presurgery; O: QoL scores; S: randomized controlled trials, case-control studies, or cohort studies) in the Cochrane Library, MEDLINE, EMBASE, Web of Science, EBSCO, and China National Knowledge Infrastructure (CNKI) databases up to June 28, 2020. Then, two reviewers independently performed article screening, data extraction, and study quality evaluation. Stata 15.0 software was utilized for data analysis. Nine studies with 1476 patients were ultimately included. QoL in global health status improved until 12 months after surgery with a maximum improvement (6.99 [0.31, 13.68], P = 0.04), and QoL in emotional functioning reduced significantly until 12 months after surgery with a maximum reduction (14.87 [10.29, 19.45], P < 0.00001). All of the symptom scales were reduced significantly until 12 months postoperation, indicating quality of life improvement. There was a clinical reduction in QoL but symptom experience (-3.31 [-5.51, -1.12], P=0.003) at six months after surgery compared with baseline (presurgery), with only sexual worry being statistically significant (4.61 [0.95, 8.27], P=0.01). The recovery time varied among each dimension of the postoperative QoL of patients with gynecological malignancies; only a few functions and symptoms began to improve at 1 month postoperation and more at 12 months postoperation. Therefore, it is vitally important to develop extended care programs targeting the multidimensional aspects of QoL for patients with gynecological malignancies after surgery.

Low energy amplitude modulated radiofrequency electromagnetic fields in combination with standard treatment or as monotherapy to show improvement in quality of life in patients with advanced hepatocellular carcinoma.

290 Background: Hepatocellular carcinoma (HCC) is a fatal cancer without curative option for most patients. Hence the importance to improve health related quality of life (HRQoL). Amplitude-modulated radiofrequency electromagnetic fields (EMF), as a novel and non-toxic therapy, has potential for improving HRQoL in advanced HCC patients. Methods: An open-label, single center, prospective clinical protocol was performed in advanced HCC patients as an initial and salvage treatment modality. Systemic exposure to EMF was used in combination with a systemic conventional treatment or as a single treatment. A spoon-shaped antenna placed in the oral cavity delivered EMF over 90 minutes with monthly repetitions until death or consent withdrawal. The effect on HRQoL was the primary objective of this study. Patients answered the EORTC-C30 v3.0 questionnaires prior to every EMF exposure. Clinically meaningful change (CMC) and time to deterioration (TTD) for Global Health (QoL), Role Functioning (RF) and Physical Functioning (PF) were used in the analysis. Results: From March 2018 to April 2020, 55 advanced HCC patients were submitted to 373 EMF exposures. 41/55 (75%) patients had repetitive exposures (mean # 4, ranging from 2-16). 87% were male, median age was 67, 84% were BLCL-C, 16% were Child-Pugh B, 29% had extra-hepatic metastasis, 55% had failed previous treatment and 71% had documented radiological progression. 31(56%) patients received EMF in combination with systemic therapy (28 TKI and 3 anti-PDL1). 24 patients received EMF as a single treatment modality. The mean baseline score was 68.1 for QoL and 77.1 for RF and PF. 61%, 76% and 49% of patients experienced positive change in QoL, RF and PS scores immediately prior to the second exposure, respectively. +CMC was reported in 20%, 17% and 32% of patients, respectively for QoL, RF and PS. The median QoL TTD was not reached. The median RF TTD was 7.2 month and the median PF TTD was 11.9 month. The median RF TTD for patients in combination treatment was 11.4 months and in a single treatment was 13.5 month. The median PF TTD for patients in combination treatment was 12.8 months and in single treatment was 14.5 month. Conclusions: Advanced HCC patients showed positive changes in QoL, RF and PF HRQoL scores after single exposure to EMF. The benefit from EMF in HRQoL was durable both in combination with TKI or as a single modality in advanced HCC patients. These results support future development as a novel palliative treatment modality in advanced HCC patients. Clinical trial information: NCT 01686412.

Longitudinal change of quality of life in the first five years of survival among disease-free Chinese breast cancer survivors.

This study aimed to investigate changes of QoL during the first 5 years of survival among disease-free Chinese breast cancer survivors. A prospective cohort study enrolled 1462 Chinese women with early-stage breast cancer, and longitudinally visited those patients at four time-points, namely baseline (T0), 18- (T1), 36- (T2), and 60-month (T3) after diagnosis. This study included 992 patients who were disease-free during the first 5 years of survival and who had completed QoL assessments at all four time-points. The score of global health status/QoL improved gradually (T1, T2, T3 > T0; P < 0.001 for overall comparisons). Social functioning score significantly improved when compared to that of T0 (T1, T2, T3 > T0; P < 0.001 for overall comparisons). In contrast, cognitive functioning score decreased (T0 > T1, T2, T3; P < 0.001 for overall comparisons). Scores of physical functioning, role functioning and emotional functioning showed a fluctuated picture, with the highest score achieved at T1. In symptoms profile, most of them scored lowest at T1 (best QoL). Multivariate analysis showed that several characteristics significantly correlated to changes in QoL from T0 to T3. For instance, patients with higher education had better recovery of physical functioning, role functioning, and social functioning. During the first 5 years of survival, patients' global health status/QoL improved over time, social functioning consistently improved, but cognitive functioning steadily deteriorated. Most of functioning domains and symptoms improved at 18-month follow-up, but such improvements were not maintained and even deteriorated at 36- and 60-month post-diagnosis. This study suggested that some interventions should be investigated during such period.

Parotid sparing and quality of life in long-term survivors of locally advanced head and neck cancer after intensity-modulated radiation therapy.

Intensity-modulated radiation therapy (IMRT) enables radiation oncologists to optimally spare organs at risk while achieving homogeneous dose distribution in the target volume. Despite great advances in technology, xerostomia is one of the most detrimental long-term side effects after multimodal therapy in patients with locally advanced head and neck cancer (HNC). This prospective observational study examines the effect of parotid sparing on quality of life in long-term survivors. A total of 138patients were grouped into unilateral (n = 75) and bilateral (n = 63) parotid sparing IMRT and questioned at 3, 24, and 60-month follow-up using the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-H&N35 questionnaires. Treatment-related toxicity was scored according to the RTOG/EORTC toxicity criteria. Patients' QoL24 and 60months after IMRT was analyzed by ANCOVA using baseline QoL (3months after IMRT) as acovariate. Patients with bilateral and unilateral parotid-sparing IMRT surviving 60months experience similar acute and late side effects and similar changes in QoL. Three months after IMRT, physical and emotional function as well as fatigue, nausea and vomiting, pain, dyspnea, and financial problems are below (function scales) or above (symptom scales) the threshold of clinical importance. In both groups, symptom burden (EORTC H&N35) is high independent of parotid sparing 3months after IMRT and decreases over time in asimilar pattern. Pain and financial function remain burdensome throughout. Long-term HNC survivors show asimilar treatment-related toxicity profile independent of unilateral vs. bilateral parotid-sparing IMRT. Sparing one or both parotids had no effect on global QoL nor on the magnitude of changes in function and symptom scales over the observation period of 60months. The financial impact of the disease and its detrimental effect on long-term QoL pose an additional risk to unmet needs in this special patient population. These results suggest that long-term survivors need and most likely will benefit from early medical intervention and support within survivorship programs.

Health-related quality of life and overall survival: a prospective study in patients with head and neck cancer treated with radiotherapy

PurposeWe aimed to examine whether pre-treatment, post-treatment and change in health-related quality of Life (HRQoL) is associated with survival, in patients with head and neck cancer (HNC).MethodsWe included 948 newly diagnosed HNC patients treated with primary or adjuvant (chemo)radiotherapy with curative intent. The EORTC QLQ-C30 questionnaire was assessed pre-treatment and at 6 weeks, 6 months and 12 months post-treatment. Multivariable Cox regression analyses were performed to examine whether HRQoL at all time points and changes in HRQoL over time were associated with survival, after adjusting for demographic, clinical and lifestyle-related variables.ResultsHigher HRQoL scores were significantly associated with improved 5-year overall survival at all time points, except for the subscale global QoL at 6 weeks. Changes in HRQoL at 6 weeks post-treatment compared to pre-treatment were not significantly associated with survival. Changes in physical (HR: 0.88 95% CI: 0.82–0.96) and emotional functioning (HR: 0.90 95% CI: 0.85–0.96) from pre-treatment to 6 months post-treatment and changes in global QOL, and physical, emotional, and social functioning from pre-treatment to 12 months post-treatment were significantly associated with survival.ConclusionHigher HRQoL reported pre-treatment and post-treatment (6 weeks, 6 months and 12 months) are significantly associated with improved survival, as well as changes in HRQoL at 6 and 12 months compared to pre-treatment. Our results highlight the value of monitoring HRQoL and to identify those patients that report decreased or deteriorated HRQOL. This may help to further improve cancer care in a timely and efficient manner.

Changes in health-related quality of life among older adults aging with long-term spinal cord injury

Study designCross-sectional and longitudinal.ObjectivesTo (i) describe health-related quality of life (HRQoL) and changes over 6 years in older adults aging with long-term spinal cord injury (SCI) and (ii) investigate how changes in HRQoL are associated with age, gender, and injury characteristics.SettingCommunity in southern Sweden.MethodsFrom the initial 123 participants (years 2011–2012) in the Swedish Aging with Spinal Cord Injury Study (SASCIS), 77 individuals (32% women, C1-L3, AIS A–D, median age 66 years, median time since injury 31 years, 30% complete injuries) were assessed 6 years later. HRQoL was rated with the Spinal Cord Injury Quality of Life Questionnaire (SCI QL-23). Associations were investigated using multivariable linear regression analyses.ResultsThe median rating of global QoL (scale range 0–100) was relatively high at both assessments (67 and 83, respectively). There was a large variability in all HRQoL-domains and no significant changes over 6 years. As compared to an AIS D injury, a tetraplegia AIS A–C injury and tetraplegia and paraplegia AIS A–C injuries were associated with positive change in depressive symptoms and global QoL, respectively.ConclusionsOlder adults aging with long-term SCI show large variations in all HRQoL-domains and have the potential to maintain a high and stable level of HRQoL over time. Persons with AIS D injuries may need increased attention to mitigate negative changes in depressive symptoms and global QoL. Further studies are needed to identify modifiable factors associated with changes in HRQoL in older adults aging with long-term SCI.

Rectum Dose-Volume Histogram (DVH) Parameters And Patient-Reported EPIC-Bowel Domain For Patients Undergoing Radiotherapy (RT) For Prostate Cancer (PC): A Single-Center Prospective Registry Experience

Prostate cancer therapy toxicities can affect QOL. We report one of the first analyses of rectal dose and changes in QOL measured with the EPIC bowel domain in PC patients treated with curative intent RT in a large, single-institution prospective registry. Two hundred fifty-two pts with localized PC were treated with curative intent RT from 2016- 2018 on an IRB approved prospective registry. The Expanded Prostate Cancer Index Composite (EPIC) health-related QOL instrument was administered at baseline, end-of-treatment, 3, 6, 12 months (m), and then annually. A higher EPIC score implies less bowel symptom burden. DVH parameters for the rectal structure were computed, Dx was the dose (Gy) to a % of the rectum and Vx was the % volume receiving a given dose (Gy). Rectal dose was analyzed using BED (alpha/beta = 3), EQD2Gy, and total dose. In order to determine optimal cut-points to find clinically meaningful DVH, we utilized logistic regression and defined the ‘best’ cut-point to be the value that maximized Youden’s Index. Repeated measures mixed models were then implemented to determine the effect of patient, clinical, and treatment factors (including DVH) on patient-reported bowel symptom burden (EPIC-Bowel). Median follow-up was 20mo(range:2.5–40), pre-RT PSA = 6.12(1.3–129), T Stage T1c(T1b–T3b), Gleason Score 7(range 6-10), and 99% N0. The median prescribed dose was 70Gy (38–79.2) in 5 to 44 fractions. Standard fractionation (1.8-2Gy) was used in 120 pts (48.2%), moderate hypofractionation (2.5-3Gy) in 87 pts (35.1%), and extreme hypofractionation (>6Gy) in 42 pts (16.7%). Globally, treatment had minimal effect over EPIC-bowel scores which remained unchanged over time, with a median baseline = (96.4), end-of-treatment = (94.6), 3mo = (95.4), 6mo = (96.4), 12m = (94.6), and 24m = (96.4). However, rectal dose affected QOL with the strongest DVH signals noted for BED V51Gy and EQD2 V22Gy—with an optimal cut-point of 14.4% and 16.4%, respectively. On multivariate modeling BED V51Gy >14.4% was significantly associated with a decline of the epic bowel domain of 2.1 points (p = 0.01), and an EQD2 V22Gy >16.4% was significantly associated with a decline of 2.3 points (p<0.003). Rectal dose, specifically BED V51Gy>14.3% and EQD2 V22Gy>16.4%, are significantly associated with decline in bowel related QOL in patients undergoing definitive RT for localized PC. This is one of the first studies to examine rectal dose and correlate them to patient reported treatment related QOL.

Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: secondary outcomes from a cluster randomized controlled trial (DiaFOTo)

BackgroundFollow-up care provided via telemedicine (TM) is intended to be a more integrated care pathway to manage diabetes-related foot ulcers (DFU) than traditionally-delivered healthcare. However, knowledge of the effect of TM follow-up on PROMs including self-reported health, well-being and QOL in patients with DFUs is lacking and often neglected in RCT reports in general. Therefore, in this study of secondary outcomes from the DiaFOTo trial, the aim was to compare changes in self-reported health, well-being and QOL between patients with DFUs receiving telemedicine follow-up care in primary healthcare in collaboration with specialist healthcare, and patients receiving standard outpatient care.MethodsThe current study reports secondary endpoints from a cluster randomized controlled trial whose primary endpoint was ulcer healing time. The trial included 182 adults with diabetes-related foot ulcers (94/88 in the telemedicine/standard care groups) in 42 municipalities/districts, recruited from three clinical sites in Western Norway. Mean (SD) diabetes duration for the study population was 20.8 (15.0). The intervention group received care in the community in collaboration with specialist healthcare using an asynchronous telemedicine intervention. The intervention included an interactive web-based ulcer record and a mobile phone enabling counseling and communication between the community nurses and specialist healthcare; the control group received standard outpatient care. In total 156 participants (78/78) reported on secondary endpoints: self-reported health, well-being and quality of life evaluated by generic and disease-specific patient-reported outcome measures (e.g. Euro-QOL, the Hospital Anxiety and Depression Scale (HADS), Problem Areas in Diabetes (PAID), Neuropathy and Foot Ulcer–Specific Quality of Life Instrument (NeuroQOL)). Linear mixed-effects regression was used to investigate possible differences in changes in the scores between the intervention and control group at the end of follow-up.ResultsIn intention to treat analyses, differences between treatment groups were small and non-significant for the health and well-being scale scores, as well as for diabetes-related distress and foot ulcer-specific quality of life.ConclusionsThere were no significant differences in changes in scores for the patient reported outcomes between the intervention and control group, indicating that the intervention did not affect the participants’ health, well-being and quality of life.Trial registrationClinicaltrials.gov, NCT01710774. Registered October 19th, 2012.

Osteoporosis and Health-Related Quality of Life Among Older Women

Background: Osteoporosis, a systemic skeletal disease characterized by low bone mass, poses a significant disease burden for older women. Often assessed using Health-Related Quality of Life (HRQoL) scale, the association between osteoporosis and HRQoL is scarce, with the majority of quality of life studies focused on osteoporotic women post fracture. Purpose: The study’s primary objectives were to examine if differences exist in HRQoL among women greater than 50 years of age who have and/or do not have osteoporosis and to gain insight into the relationship of HRQoL and osteoporosis.Methods: A retrospective cross-sectional design involving data extraction on women aged 50 years or older from 2014 Medical Expenditure Panel Survey (MEPS) was used (N = 4,661). HRQoL was measured by the generic Short-Form-12 Version 2 Physical (PCS) and Mental Health (MCS) component summary scores. The differences between osteoporosis and PCS and MCS were examined using t-tests and multivariable ordinary least squares regression.Results: Overall, 4.1% women aged 50 and older had osteoporosis. In both bivariate and multivariable analyses, no statistically significant differences were observed in HRQoL measures between women with and/or without osteoporosis. Conclusion: No group differences in HRQoL by osteoporosis status suggest the need for additional research using other research methodologies to flush out nuances in QOL changes. Clinician actions focused on insured and uninsured women with osteoporosis must include early and ongoing QOL assessment, with a focus on physical changes overtime

Quality of Life Changes in Acute Coronary Syndromes Patients: A Systematic Review and Meta-Analysis.

There is little up-to-date evidence about changes in quality of life following treatment for acute coronary syndrome (ACS) patients. The main aim of this review was to assess the changes in QoL in ACS patients after treatment. We undertook a systematic review and meta-analysis of quantitative studies. The search included studies that described the change of QoL of ACS patients after receiving treatment options such as percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) and medical therapy (MT). We synthesized findings using content analysis and pooled the estimates using meta-analysis. We used the PRISMA guidelines to select and appraise the studies and report the findings. Twenty-nine (29) articles were included in the review. We found a significant improvement of QoL in ACS patients after receiving treatment. Particularly, the meta-analytic association found that the mean QoL of patients diagnosed with ACS was higher after receiving treatment compared to baseline (overall pooled mean difference = 31.88; 95% CI = 31.64–52.11, I2 = 98) with patients on PCI having slightly lower QoL gains (pooled mean difference = 30.22; 95% CI = 29.9–30.53, I2 = 0%) compared to those on CABG (pooled mean difference = 34.01; 95% CI = 33.66–34.37, I2 = 0%). The review confirmed that QoL of ACS patients improved after receiving treatment therapies although varied by the treatment options and patients’ preferences. This suggests the need to perform further study on the QoL, patient preferences and physicians’ decision to prescription of treatment options.

The Feasibility and Impact of a Presurgical Exercise Intervention Program (Prehabilitation) for Patients Undergoing Cystectomy for Bladder Cancer

To assess the feasibility of a prehabilitation program for cystectomy patients and to determine the effectiveness of the program in improving strength and functional capacity in the peri-operative period. This phase I/II study accrued patients ≥60 years old from January 2013 to October 2017 with biopsy-proven bladder cancer, Karnofsky performance score ≥70 and a sedentary baseline lifestyle to participate in a 4-week supervised preoperative exercise training program. Primary outcomes were feasibility and safety; secondary outcomes included changes in fitness, patient-reported QOL, peri-operative complications and readmissions. Student's ttests and Wilcoxon signed-rank test were performed. Fifty-four patients enrolled in the program. Successful completion, defined as patients who began the program and adhered to >70% of the sessions, was attained by 41 of 51 patients (80.4%, 90% CI [71%-90%]). There were no adverse events. Fitness and patient-reported QOL improved postintervention, with sustained improvements in general and mental health 90-days postsurgery. The primary limitation is no control group. Prehabilitation prior to cystectomy is feasible, safe, and results in improvements in patient strength, endurance and sustained improvements in patient-reported QOL from baseline. Efforts to further evaluate the impact of prehabilitation in this population in an expanded and randomized fashion are warranted.