Prospective Quality Of Life Study Research Articles

Ejaculatory Function Following Stereotactic Body Radiation Therapy for Prostate Cancer

Ejaculatory dysfunction is an important male quality of life issue which has not yet been studied in the setting of prostate stereotactic body radiation therapy (SBRT). The purpose of this study is to evaluate ejaculatory function following SBRT for prostate cancer. Two hundred and thirty-one patients on a prospective quality of life study with baseline ejaculatory capacity treated with prostate SBRT from 2013 to 2019 were included in this analysis. Ejaculation was assessed via the Ejaculation Scale (ES-8) from the Male Sexual Health Questionnaire. Patients completed the questionnaire at 1, 3, 6, 9, 12, 18, and 24 months post-SBRT. Elderly patients (Age > 70) and those who received hormonal therapy were excluded from analysis. Patients were treated to 35-36.25 Gy in 5 fractions delivered with theCyberKnifeRadiosurgical System (Accuray). Ejaculatory function was assessed by ES-8 scores (range 4-40) with lower values representing increased interference or annoyance. Median age at the time of treatment was 65 years. Median follow up was 24 months (IQR 19-24.5 months). 64.5% of patients had ED at baseline (SHIM < 22). The 2-year anejaculation rate was 15%. Mean composite ES-8 scores showed a decline in the first month following treatment then stabilized: 30.4 (start of treatment); 26.5 (1 month); 27.6 (3 month); 27.0 (6 month); 26.2 (9 month); 25.4 (12 month); 25.0 (18 month) and 25.4 (24 month). White race, higher pre-treatment SHIM (≥22), and higher ES-8 (≥31) at treatment start were significantly associated with a decreased probability of a clinically significant decline. Patient-reported ejaculate volume was significantly reduced at all time points post-SBRT. Ejaculatory discomfort peaked at 1 month and 9 months post-SBRT. Prior to treatment, 8.0% of men reported that they were very to extremely bothered by their ejaculatory dysfunction. The number of patients reporting this concern increased to 14.4% at one year and dropped to 11% at 24-months post-SBRT. Patients undergoing prostate SBRT may experience meaningful changes in ejaculatory function and should be counseled on the trajectory of these side effects. This was a retrospective analysis of a prospectively maintained database. Subjective questionnaire responses captured limited aspects of ejaculatory function in this cohort. The high incidence of moderate to extreme bother in ejaculatory function before and after SBRT suggests a need for novel approaches to improving ejaculation. Sholklapper T, Creswell M, Cantalino J, etal. Ejaculatory Function Following Stereotactic Body Radiation Therapy for Prostate Cancer. J Sex Med 2022;19:771-780.

Ejaculatory Function Following Stereotactic Body Radiation Therapy for Prostate Cancer

Ejaculatory dysfunction after prostate radiation therapy is an important quality of life issue with limited management options. Given the high biologically effective doses (BEDs) that are delivered with stereotactic body radiation therapy (SBRT), ejaculatory dysfunction may be more common and/or more severe than with alternative external beam approaches. The purpose of this study is to evaluate ejaculatory preservation following SBRT for prostate cancer.231 patients on a prospective quality of life study (IRB#: 2009-510) with baseline ejaculatory capacity treated with prostate SBRT at a single institution from 2013 to 2019 were included in this analysis. Ejaculatory function was assessed via the validated Ejaculation Scale (ES-8) from the Male Sexual Health Questionnaire (Rosen RC et al, 2004). ES-8 scores range from 3 - 40 with lower values representing increased interference or annoyance. The ES-8 includes questions about ejaculate volume, ejaculatory pain, and bother. Patients completed the questionnaire on the first day of treatment and at 1, 3, 6, 9, 12, 18, and 24 months post-SBRT. Elderly patients (Age > 70) and those who received hormonal therapy were excluded from this analysis. All patients were treated to 35-36.25 Gy in 5 fractions delivered with a frameless robotic radiosurgery system. Data analysis was performed using XLStat. Minimally important differences (MID) were calculated by obtaining half the standard deviation at time of start of treatment.Mean age at treatment was 64.2 years. Minimum follow-up was 24 months. Mean composite ES-8 scores showed a decline in the first month following treatment then stabilized: 30.3 (baseline); 26.7 (1 month); 27.6 (3 month); 26.9 (6 month); 26.0 (9 month); 25.4 (12 month); 25.0 (18 month) and 25.3 (24 month). The decline from baseline to one month was statistically significant (P < 0.0001). A clinically significant decrease (MID = 3.5) was achieved at 1 month (-3.6) and from 9 months (-4.3) through 24 months (-4.9). Ejaculate volume was statistically significantly reduced at all time points post-SBRT. Ejaculate volume reduction was clinically significant (MID = 0.57) from 6-24 months post SBRT. There was a clinically significant increase (MID = 0.53) in pain with ejaculation at 1-month (-0.67), 9-months (-0.63), and 12-months (-0.59). Prior to treatment, 7.6% of men reported that they were very to extremely bothered by their ejaculatory dysfunction. This was significantly increased to 14.5% at one-year (P = 0.01) and to 10.6% at 18-months (P = 0.048) post-SBRT.Men undergoing SBRT monotherapy for prostate cancer have a small decline in their overall ejaculatory function from baseline to one-month post-treatment, but stable function thereafter. Bother with ejaculation peaked at one year then slowly declined. Longer follow-up is required to confirm the durability of these findings.

P05.13 Central vs Peripheral Thoracic Malignancies Treated with SBRT: Early Outcomes of a Prospective Quality of Life Study

Thoracic malignancies in close proximity to central mediastinal structures are known to have a higher rate of treatment-related toxicity following stereotactic body radiation therapy (SBRT). Intrinsic damage secondary to tumor invasion may contribute to this increased toxicity and could be identified by pretreatment quality of life metrics. The appropriate dose fractionation schedule as well as daily treatment schedule that may mitigate the aforementioned central toxicity remains nebulous. We reviewed patients on a prospective trial assessing quality of life before and after SBRT and stratified based on central versus peripheral anatomical location. In this single institutional study, patients were enrolled on a prospective quality of life trial approved by the local Institutional Review Board. All patients were evaluated by a multidisciplinary thoracic oncology team and were diagnosed with thoracic malignancy amenable to stereotactic body radiation therapy delivered in 5 or fewer treatment fractions on an every other day schedule. Central tumors were defined as those within 2 cm of central mediastinal structures including the proximal bronchial tree. Patients underwent pre-and post-treatment quality of life questionnaires including the prospectively validated EORTC Quality of Life Core questionnaire (QLQ-C30 version 3) and Supplemental Lung Cancer module questionnaire (QLQ-LC13). Baseline differences between groups were analyzed using the Mann-Whitney U and Chi-squared tests. Score comparisons for EORTC questionnaires pre- and post- SBRT were conducted using the Wilcoxon signed-rank test. All statistics were performed in SPSS, version 24. A total of 31 patients from February 2018 to February 2020 were enrolled with a median age of 70 (59-90) years. The majority of patients had an ECOG of 1 (n = 15) and the most common histology was adenocarcinoma (n = 17). A total of 13 patients were found to have central lung tumors. There were no significant pretreatment differences in age, performance status, gender or the predefined EORTC questionnaire-specific subcategorized functional, quality of life, or symptom domains between patients diagnosed with central versus peripheral tumors. Following SBRT, there were notable, statistically significant improvements in the Emotional functioning (EF) domain (pre- and post- treatment median: 61.5 and 91.7, respectively, z=-2.01, p=.044) and the Cognitive functioning (CF) domain (pre- and post- treatment median: 75.0 and 91.7, respectively z=-2.06, p=.039) in patients treated for central lung tumors. Similar improvements were not observed in patients treated for peripheral lung tumors. There were no significant changes in any other functional, symptom, or quality of life domain following treatment for either group. Pretreatment EORTC quality of life metrics did not demonstrate significant differences in patients diagnosed with central versus peripheral thoracic malignancies in our prospective cohort. However, patients with central lung tumors experienced significant improvements in their EF and CF domains following SBRT. These findings suggest patients with central lung tumors may experience greater psychological distress from their disease independent of self-reported physical symptom burden.

The Minimal Clinically Important Difference of the Anterior Skull Base Nasal Inventory-12.

The minimal clinically important difference (MCID) is defined as the smallest change in health-related quality of life (QOL) that patients consider meaningful. The MCID is essential for determining clinically significant changes, rather than simply statistically significant changes, in QOL scores. The Anterior Skull Base Nasal Inventory-12 (ASK Nasal-12), a site-specific sinonasal QOL instrument, has emerged as a standard instrument for assessing QOL in patients who have undergone endonasal transsphenoidal surgery. To determine the MCID for the ASK Nasal-12. Distribution- and anchor-based methods were used to determine the MCID for the ASK Nasal-12 based on raw data from a multicenter prospective QOL study of 218 patients. Two distribution-based statistical methods, the one-half standard deviation method and the effect-size method, both yielded MCIDs of 0.37 (medium effect). The first anchor-based method, using the 2-wk postoperative overall nasal functioning item as the anchor, yielded an MCID of 0.31. The second anchor-based method, using the 2-wk postoperative Short Form Health Survey 8 bodily pain item as the anchor, yielded an MCID of 0.29. The largest MCID obtained for the ASK Nasal-12 using 4 statistical methods 2 wk postoperatively was 0.37. This information provides clinicians with an essential context for determining the clinical significance of changes in QOL scores after interventions. Our results will help clinicians better interpret QOL scores and design future studies that are powered to detect meaningful QOL changes.

Cohort study of long-term survival and quality of life following pelvic exenteration.

BackgroundPelvic exenteration (PE) is the preferred treatment available for selected patients diagnosed with locally advanced or recurrent cancer confined to the pelvis. Currently, the majority of the literature reports only on short‐term survival and quality‐of‐life (QoL) outcomes. The aim of this prospective cohort study was to describe long‐term survival and QoL outcomes following PE.MethodsThis was a cohort study of consecutive patients undergoing PE from 1994 to 2016 at a major teaching hospital in Sydney, Australia. From 2008, consenting patients were also included in a prospective QoL study. Main outcomes were long‐term survival and QoL assessed with SF‐36® and FACT‐C questionnaires. Survival was estimated using the Kaplan–Meier method.ResultsSome 515 patients underwent PE for locally advanced or recurrent cancer. The cumulative 5‐ and 10‐year overall survival rates were 48·6 and 37·8 per cent respectively. The survival estimates were significantly higher for patients with advanced primary rectal cancer (P = 0·045) and those in whom a clear resection margin was achieved (P < 0·001). Some 287 patients were enrolled into the QoL study. Response rates at baseline, 6 months and 5 years were 92·0, 70·0 and 33 per cent respectively. Patients had recovered to their preoperative QoL status by 6 months and, among survivors, QoL remained essentially unchanged during the 5‐year follow‐up.ConclusionPatients who underwent PE owing to advanced primary rectal cancer or achieved a clear resection margin had a greater chance of survival. Overall, QoL returned to baseline within 6 months after surgery.

The impact of lung cancer surgery on quality of life trajectories in patients and family caregivers

ObjectivesFamily caregivers (FCGs) play an important role in the quality of life (QOL) of lung cancer patients. FCGs experience significant psychological distress related to their caregiving role, but there is relatively little data about FCG QOL after cancer surgery. We sought to describe QOL trajectories for patients and their FCGs after lung cancer surgery. MethodsThis is a secondary analysis of a larger, prospective QOL study, testing the effectiveness of an interdisciplinary palliative care intervention for lung cancer patients and FCGs in a single institution. The intervention included interdisciplinary care planning and formal education sessions for both patients and FCGs. This subset analysis included patients who underwent surgery and had a matching FCG with complete QOL data (41 pairs of patients and caregivers out of 112 surgical patients). Patient QOL was assessed with the Functional Assessment of Cancer Therapy-Lung tool. FCG QOL was assessed with the FCG version of the City of Hope QOL tool. Psychological distress was assessed using the Distress Thermometer. ResultsPsychological distress levels were highest for patients (3.8/10) and FCGs (5.1/10) before surgery. Distress levels decreased among patients at six (2.9/10) and 12 weeks (2.2/10, p=0.001) later, but remained elevated among FCGs (4.2/10 and 4.4/10, p=0.157). Compared with usual care, patients in the intervention group reported improved physical and functional QOL outcomes at 12 weeks (p<0.01), but there was no significant benefit seen for FCGs in any domain (p>0.05). ConclusionsFCGs of lung cancer patients experience significant psychological distress. FCGs continue to have impaired QOL 3 months after surgery. The trajectory of QOL for FCGs does not mirror that of patients. Our palliative care intervention showed improved QOL outcomes for this subset of patients but was not effective for their FCGs.Trial Registration: NCI sponsored, trial identifier NCT00823667 https://clinicaltrials.gov/show/NCT00823667.

Intensity-modulated proton beam therapy (IMPT) versus intensity-modulated photon therapy (IMRT) for patients with oropharynx cancer – A case matched analysis

BackgroundOwing to its physical properties, intensity-modulated proton therapy (IMPT) used for patients with oropharyngeal carcinoma has the ability to reduce the dose to organs at risk compared to intensity-modulated radiotherapy (IMRT) while maintaining adequate tumor coverage. Our aim was to compare the clinical outcomes of these two treatment modalities. MethodsWe performed a 1:2 matching of IMPT to IMRT patients. Our study cohort consisted of IMPT patients from a prospective quality of life study and consecutive IMRT patients treated at a single institution during the period 2010–2014. Patients were matched on unilateral/bilateral treatment, disease site, human papillomavirus status, T and N status, smoking status, and receipt of concomitant chemotherapy. Survival analyzes were performed using a Cox model and binary toxicity endpoints using a logistic regression analysis. ResultsFifty IMPT and 100 IMRT patients were included. The median follow-up time was 32months. There were no imbalances in patient/tumor characteristics except for age (mean age 56.8years for IMRT patients and 61.1years for IMPT patients, p-value=0.010). Statistically significant differences were not observed in overall survival (hazard ratio (HR)=0.55; 95% confidence interval (CI): 0.12–2.50, p-value=0.44) or in progression-free survival (HR=1.02; 95% CI: 0.41–2.54; p-value=0.96). The age-adjusted odds ratio (OR) for the presence of a gastrostomy (G)-tube during treatment for IMPT vs IMRT were OR=0.53; 95% CI: 0.24–1.15; p-value=0.11 and OR=0.43; 95% CI: 0.16–1.17; p-value=0.10 at 3months after treatment. When considering the pre-planned composite endpoint of grade 3 weight loss or G-tube presence, the ORs were OR=0.44; 95% CI: 0.19–1.0; p-value=0.05 at 3months after treatment and OR=0.23; 95% CI: 0.07–0.73; p-value=0.01 at 1year after treatment. ConclusionOur results suggest that IMPT is associated with reduced rates of feeding tube dependency and severe weight loss without jeopardizing outcome. Prospective multicenter randomized trials are needed to validate such findings.

Prospective Quality of Life Study for Colorectal Cancer Patients with Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy.

Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is becoming accepted treatment for peritoneal carcinomatosis (PC) from colorectal cancer. Quality of life (QoL) for patients after surgery is still a concern amongst physicians despite studies that show that QoL recovers after surgery. We conducted a prospective QoL study on patients undergoing CRS and HIPEC and attempt to identify factors that affect the QoL. Patients who underwent CRS and HIPEC for PC from colorectal cancer from March 2012 to January 2015 were included. The European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30) and the colorectal module (QLQ-CR29) were administered prior to surgery and thereafter at 3, 6, and 12months. Twenty-three patients underwent 25 procedures. Median disease-free survival was 12.9months [95% confidence interval (CI) 2.5-19.3]. Physical and role functioning scores decreased at 3months but returned to baseline at 6months. There were significant increases in emotional and social functioning scores at 6-12months and improvements in all symptoms scales at 6-12months, especially the fatigue and appetite scores. A higher PCI score, longer duration of surgery, the presence of a stoma, and recurrence within 3months were associated with a poorer QoL. QoL after CRS and HIPEC improved or returned to baseline in all categories by 6-12months after surgery. Patient selection is important not only for improved survival but also for improved QoL.

Prospective Quality of Life Study of South African Women Undergoing Treatment for Advanced-stage Cervical Cancer

PurposeThe majority of South African cervical cancer patients present with advanced-stage disease. Chemoradiation therapy, in comparison with radiation therapy, results in marginally improved survival in women with advanced cervical cancer. The impact on the quality of life due to the addition of a chemosensitizer in a situation of limited survival benefits warrants objective assessment. This prospective study compares the quality of life for women with cervical cancer and treated with radiation or chemoradiation therapy at Tygerberg Hospital, South Africa. MethodsA prospective study was done in a population with a high incidence of advanced cervical cancer. Quality of life measurements were done at pretreatment, post treatment, and follow-up. The European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire and the Cervix Cancer Module were used. FindingsThe study included 219 women. Forty-four women were treated with primary surgery. A total of 102 women completed primary radiation therapy and 73 women completed primary chemoradiation therapy. The demographic characteristics of the last 2 treatment groups were different. Women receiving chemoradiation therapy had a higher educational level (P < 0.01) and had less advanced stage (III or IV) cervical cancer (P < 0.01). Radiation therapy was used significantly more in HIV-positive women. The presiding clinicians chose treatment options based on clinical factors unrelated to quality of life. Chemoradiation therapy resulted in statistically more improvement in the pain (P < 0.05), fatigue (P < 0.05), appetite loss (P < 0.01), and nausea and vomiting (P < 0.05) quality of life domains. In these domains, pretreatment quality of life scores were significantly higher in the radiation therapy group, implying a poorer quality of life status at the initiation of treatment. In post hoc analysis, the global health domain was significantly more improved (P = 0.03) by chemoradiation. Peripheral neuropathy was not increased by chemoradiation. ImplicationsChemoradiation therapy improved quality of life more than radiation therapy in certain domains. This allows for selection of chemoradiation as a treatment option in situations where quality of life is the end point of treatment.

MP60-03 IMPACT OF POST-OPERATIVE COMPLICATIONS AND THE NUMBER OF ‘HOSPITAL-FREE DAYS’ FOLLOWING RADICAL CYSTECTOMY ON QUALITY OF LIFE AT ONE YEAR

You have accessJournal of UrologyBladder Cancer: Invasive III1 Apr 2014MP60-03 IMPACT OF POST-OPERATIVE COMPLICATIONS AND THE NUMBER OF ‘HOSPITAL-FREE DAYS’ FOLLOWING RADICAL CYSTECTOMY ON QUALITY OF LIFE AT ONE YEAR Chad R. Ritch, Michael S. Cookson, Sam S. Chang, Peter E. Clark, David F. Penson, Joseph A. Smith, Alex T. May, Christopher B. Anderson, Haerin Lee, Chaochen You, and Daniel A. Barocas Chad R. RitchChad R. Ritch More articles by this author , Michael S. CooksonMichael S. Cookson More articles by this author , Sam S. ChangSam S. Chang More articles by this author , Peter E. ClarkPeter E. Clark More articles by this author , David F. PensonDavid F. Penson More articles by this author , Joseph A. SmithJoseph A. Smith More articles by this author , Alex T. MayAlex T. May More articles by this author , Christopher B. AndersonChristopher B. Anderson More articles by this author , Haerin LeeHaerin Lee More articles by this author , Chaochen YouChaochen You More articles by this author , and Daniel A. BarocasDaniel A. Barocas More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.1757AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail Introduction and Objectives Radical cystectomy (RC) with urinary diversion adversely affects quality of life (QOL). However, the extent to which complications of RC, and time spent in the hospital influence later QOL is unknown. Therefore, we sought to determine the extent to which number and severity of complications and “hospital-free days” (HFDs) within 30 and 90 days of surgery predict QOL at one year. Methods We used data from a prospective QOL study, in which RC patients completed a baseline and 1 year QOL assessment, using a validated, cystectomy-specific instrument, the Vanderbilt Cystectomy Index-15 (VCI-15). Complications were graded by the Clavien system. Hospital length of stay and the length of stay during any and all readmissions were subtracted from 30 and 90 to calculate 30- and 90-day HFDs, respectively. We compared the number of HFDs among patients with varying levels of complications to determine the extent to which different measures of ‘off-pathway’ recovery are associated. We then fit models to compare the VCI-15 score 1 year after surgery by the number of complications, highest Clavien grade, and 30- and 90-day HFDs, adjusting for demographic (age, gender, comorbidities) and clinical variables (stage, diversion type, use of chemotherapy). Results A total of 104 patients with complete baseline and 1 year follow-up QOL data were included in the analysis. The median (IQR) 30- and 90-day HFDs were 24 (22-25) and 84 (82-85) days, respectively. Patients who experienced any complications (versus none) had significantly fewer 30d HFDs (22 vs. 24 days, p=0.002) and 90d HFDs (82 vs. 84 days, p<0.001), and patients with higher grade complications had fewer HFDs than those with lower-grade or no complications (p<0.001). With respect to QOL, there was no significant difference in VCI-15 scores at 1 year across strata of number of complications, grade of complications, 30-day HFDs or 90-day HFDs. On multivariable analysis, the only independent predictors of 1 year QOL were female gender and baseline QOL score. Conclusions Not surprisingly, patients who experience more severe complications following RC have fewer HFDs over the 30 and 90 day recovery periods. However, experiencing a complication, or spending more time in the hospital within 90 days of surgery does not predict QOL at 1 year among RC patients. Instead, QOL appears to be driven largely by baseline QOL and gender. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e633-e634 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Chad R. Ritch More articles by this author Michael S. Cookson More articles by this author Sam S. Chang More articles by this author Peter E. Clark More articles by this author David F. Penson More articles by this author Joseph A. Smith More articles by this author Alex T. May More articles by this author Christopher B. Anderson More articles by this author Haerin Lee More articles by this author Chaochen You More articles by this author Daniel A. Barocas More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

How distressing is referral to colposcopy in cervical cancer screening?: A prospective quality of life study

ObjectiveReferral for colposcopy because of abnormal Pap test results is likely to be distressing, but the extent and duration of these effects are unknown. We aimed to fill this gap. MethodsWe conducted a prospective observational study at two departments of Obstetrics and Gynecology (an academic and a non-academic setting). Women referred for colposcopy completed questionnaires before colposcopy, and at 1, 3, and 6months afterwards. A reference group of 706 screen participants, aged 29–60years old, was included and completed questionnaires once. Main outcome measures were generic health-related quality of life (HRQoL), assessed through the EQ-5D and the SF-12 physical and mental scores (PCS-12 and MCS-12); anxiety as assessed by STAI-6, and screen-specific anxiety as assessed by the psychological consequences questionnaire (PCQ). Results154 women responded to the questionnaire, of whom 132 were included in the analyses. Histological results were CIN 1 in 17/115 women (15%) and CIN 2+ in 62 (54%). In 36 women (31%) there was no histologically confirmed neoplasia. Before colposcopy physical HRQoL scores were similar or slightly better than in the reference group, while mental HRQoL (MSC-12) and (screen-specific) anxiety were worse (p<0.001). Irrespective of CIN-grades, anxiety washed out during follow-up (p<0.001), with changes being clinically relevant. ConclusionsReferral for gynecological evaluation because of abnormal PAP-test results was distressing. Anxiety – and not the physical burden of management – seemed to be the most bothersome to women. For all CIN-grades, distress disappeared over six months following colposcopy, suggesting a reassuring effect of gynecological management.

Proxy assessment of patients before and after radiotherapy for brain metastases

Proxies of patients with poor performance status could give useful information about the patients' quality of life (QoL). We applied a newly developed questionnaire in a prospective QoL study of patients undergoing radiotherapy for brain metastases in order to make the first move to validate this instrument, and we compared the results with scores obtained using validated patient-completed instruments. From January 2007 to June 2010, 166 patients with previously untreated brain metastases were recruited at 14 centers in Germany and Austria. The EORTC-QLQ-C15-PAL and the brain module BN20 were used to assess QoL in patients at the start of treatment and 3months later. At the same time points, 141 of their proxies estimated the QoL with the new DEGRO brain module (DBM), a ten-item questionnaire rating the general condition as well as functions and impairment by symptoms in areas relevant to patients with brain metastases. At 3months, 85 of 141 patients (60%) with initial response by a proxy were alive. Sixty-seven of these patients (79% of 3-month survivors) and 65 proxies completed the second set of questionnaires. After 3months, QoL significantly deteriorated in all items of proxy-assessed QoL except headache. Correlations between self-assessed and proxy-assessed QoL were high in single items such as nausea, headache, and fatigue. The high correlation between self-assessment and proxy ratings as well as a similar change over time for both approaches suggest that in patients with brain metastases, proxy assessment using the DBM questionnaire can be an alternative approach to obtaining QoL data when patients are unable to complete questionnaires themselves. Our self-constructed and first applied DBM is the only highly specific instrument for patients with brain metastases, but further tests are needed for its final validation.

Prospective, Long-Term Comparison of Quality of Life in Laparoscopic Versus Open Ventral Hernia Repair

To compare laparoscopic ventral hernia repair (LVHR) versus open ventral hernia repair (OVHR) for quality of life (QOL), complications, and recurrence in a large, prospective, multinational study. As recurrence rates have decreased for LVHR and OVHR, QOL has become an extremely important differentiating outcomes measure. A prospective, international database was queried from September 2007 to July 2011 for LVHR and OVHR. Carolinas Comfort Scale (CCS) was utilized to quantify QOL (pain, movement limitation, and mesh sensation) preoperatively and at 1, 6, and 12 months postoperatively. A total of 710 repairs included 402 OVHR and 308 LVHR. Demographics were mean age 57.1 ± 13.3 years, 49.6% male, 21.7% recurrent hernias, mean body mass index of 30.3 ± 6.6, and mean defect size of 89.4 ± 130.8. Preoperatively, 56.9% had pain, and 53.2% experienced movement limitation. At 1-month follow-up, 587 (82.7%) patients were provided CCS scores; more LVHR patients experienced pain (P < 0.001) and movement limitations (P < 0.001). At 6 and 12 months, there were no differences in QOL with 466 (65.6%) and 478 (67.3%) patients responding, respectively. After controlling for confounding variables, LVHR was independently associated with more frequent discomfort [odds ratio (OR) = 1.9, confidence interval (CI): 1.2-3.1], movement limitation (OR = 1.6, CI: 1.0-2.7), and overall symptoms (OR = 1.6, CI: 1.0-2.6) at 1 month. LVHR resulted in a shorter length of stay (LOS) (P < 0.001) and fewer infections (P = 0.004), but overall complication rates were equal. Recurrence rates were also equal (P = 0.66). In the largest, prospective QOL study comparing LVHR and OVHR, LVHR is associated with a decrease in QOL in the short term. LOS and infection rates are decreased in LVHR, but overall complication and recurrence rates are equal.

513 Outcome After Flexible Notes Appendectomy in Hybrid Technique and Laparoscopic Appendectomy-Final Results of the Prospective Quality of Life Study

513 Outcome After Flexible Notes Appendectomy in Hybrid Technique and Laparoscopic Appendectomy-Final Results of the Prospective Quality of Life Study

Posterior Reconstruction Before Vesicourethral Anastomosis in Patients Undergoing Robot-Assisted Laparoscopic Prostatectomy Leads to Earlier Return to Baseline Continence

Reapproximation of Denonvilliers' fascia adjacent to bladder neck to the rectourethralis, or posterior reconstruction (PR), has been suggested to improve continence in postprostatectomy patients. We examined the impact of the PR on postoperative urinary and other quality-of-life (QoL) outcomes in patients undergoing robot-assisted laparoscopic prostatectomy (RALP). We identified 89 patients who underwent RALP for prostate cancer between 2006 and 2009 by a single surgeon (R.G.), consented to participate in our prospective QoL study, which collects RAND-UCLA QoL and AUA symptom scores for all patients undergoing treatment for prostate cancer, and completed a baseline and a 3- or 6-month questionnaire. Of these, 31 patients had PR before vesicourethral anastomosis. We compared return to baseline function percentage at 3 and 6 months by PR group. Differences found in univariate analysis were further investigated using multiple linear regression models adjusting for demographics, clinical variables, and nerve-sparing status. While most patients had both 3- and 6-month follow-up (n = 74, 83%), sample size at 3 months was n = 86 and at 6 months was n = 77. Groups were comparable by preoperative characteristics, pathologic stage, nerve-sparing status, and baseline QoL/AUA symptom scores. At 3-months, there was a statistically significant improvement comparing PR to non-PR groups in return to baseline score for urinary bother (72% vs. 53%; p = 0.008) and urinary function (64% vs. 50%; p = 0.05), as well as change in absolute AUA symptom score (+0.2 vs. +3.8; p = 0.005). Differences in urinary bother (+20%; 95% confidence interval 5%, 34%) and AUA symptom score (-2.8; 95% confidence interval, -5.4, -0.2) persisted after multivariate adjustment. Groups had similar scores for all parameters by 6 months postprostatectomy. PR in patients undergoing RALP has a significant impact on early return to baseline parameters relating to urinary bother, urinary function, and AUA symptom score.

891g: Real NOTES®, Hybrid and Laparoscopic Appendectomy in Human, a Prospective Quality of Life Study Comparing Outcome After Flexible NOTES® Appendectomy in Hybrid Technique and Laparoscopic Appendectomy

Natural orifice transluminal endoscopic surgery (NOTES) is an emerging technique. The proposed advantages should be established by its comparison with standard procedures. Peri- and postoperative complications are a major focus of its evaluation.

Burden of pulmonary arterial hypertension in Germany

This study aimed to describe health care provision, resource consumption and related costs, as well as treatment patterns and quality of life in adult patients with pulmonary arterial hypertension (PAH) in Germany. Data for this retrospective and prospective cost-of-illness-study were derived from hospitals, general practitioners and patients. Costs were evaluated from the perspective of third party payer and patient. Quality of life data were collected by using three validated instruments. A total of 167 patients were enrolled at 10 hospitals. Time period from first occurrence of symptoms to confirmed diagnosis of PAH was 2.3 years on average. Mean number of GP visits was 1.5 per patient per month, and within 15 months, inpatient stays were reported for 50% of patients. The ratio of combination therapy to single-drug therapy for endothelin receptor antagonists, phosphodiesterase-5-inhibitor and prostacyclin analogues increased significantly during 15 months. Treatment costs were, on average, euro47,400 per patient per year, arising mainly from drugs. Compared to the general population, quality of life of PAH patients was considerably impaired. This is the first study which evaluated aspects of the medical and economic consequences of PAH based on a large cohort of PAH patients in Germany.

A Prospective Study of Quality of Life in Adults With Newly Diagnosed High-Grade Gliomas

To examine whether a caregiver can provide reliable proxy quality of life (QOL) ratings of their adult significant other with a newly diagnosed high-grade glioma. This prospective QOL study was a companion protocol for 3 phase II high-grade glioma protocols. At study entry, 2 months, and 4 months after enrollment, 5 self-administered forms were completed by 197 patients and their caregivers to assess QOL. Caregiver ratings of QOL were available, respectively, for 92%, 93%, and 88% of baseline, 1st, and 2nd subsequent follow-up evaluations of patients who had completed their QOL assessments. There was a strong relationship between patient and caregiver QOL scores (Spearman and intraclass correlation coefficients greater than 0.5 for 87% and 80% of the measurements, respectively); however, for some measures (eg, the profiles of mood states short form) there was better agreement between patient and caregiver scores when the QOL scores were higher. There was good agreement between patient and proxy ratings independent of the cognitive function of the patient, except for the profiles of mood states short form with better correlation between patients and caregivers for those patients without cognitive impairment. In this multi-institutional prospective study there is a strong correlation between high-grade glioma patient and caregiver QOL scores, although for some measures this correlation is stronger for those patients without cognitive impairment. To improve the acquisition and the accuracy of assessing QOL status in high-grade glioma patients, proxy ratings from caregivers should also be obtained in conjunction with the patient, and consideration be given to substituting proxy ratings when a patient's self-report is absent.

Palliation for Malignant Gastric Outlet Obstruction: A Prospective Quality of Life Study

Introduction: Gastric outlet obstruction (GOO) is a potential complication of advanced malignancy that can lead to significant morbidity and poor quality of life (QOL). Palliative options include surgical bypass, endoscopic stent or percutaneous gastrostomy (PEG) or jejunostomy (PEJ). The impact of these interventions on QOL remains poorly defined. Methods: We enrolled 50 patients with GOO secondary to unresectable primary or metastatic cancer in a prospective study examining QOL after palliative intervention. Three patients refused to participate after enrollment. Patients were divided into three groups for comparison based upon type of intervention: endoscopic stent (N = 24), surgical bypass (N = 16) or PEG/PEJ (N = 7). The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 instruments were used to assess QOL at baseline, one and three months following intervention. Results: Median overall survival was 64 days (range 5-499) for the entire group. All patients in the PEG/PEJ group died within 60 days; therefore analysis was limited to the stent and surgical bypass groups. There was a shorter length of hospital stay (LOS) and trend to lower 30-day mortality after endoscopic stent placement, but solid food intake and rates of secondary intervention for recurrent GOO were comparable (Table 1). Both endoscopic stent and surgical bypass were effective palliation based upon QOL evaluation (Table 2). Because 37% of patients refused to complete follow-up surveys at one month and 60% died of disease prior to three months, only 10 patients (21%) completed all QOL surveys. Conclusion: Malignant GOO secondary to unresectable primary or metastatic cancer is associated with poor overall survival. Endoscopic stent placement is an effective initial option and is equivalent to surgical bypass in improving immediate QOL after intervention. Quality of life studies are difficult to complete in this population due to refusal by patients to participate when very ill and short life expectancy. Table 1Comparison of palliative interventions for malignant GOO Endoscopic stent (N = 24) Surgical bypass (N = 16) PEG/PEJ (N = 7) P-value Median LOS (days) after procedure 2.5 (0-23) 10 (3-33) 9 (1-47) <0.01 30-day mortality 1 (4%) 4 (25%) 2 (29%) 0.07 Solid food at one month 9/23 (39%) 7/12 (58%) 1/5 (20%) 0.35 Solid food at three months 4/12 (33%) 4/6 (67%) 0.32 Secondary procedure for recurrent GOO 3/24 (13%) 2/16 (13%) 1.00 Open table in a new tab Table 2QOL after palliative intervention for malignant GOO Endoscopic stent (N = 24) Surgical bypass (N = 16) Change in median overall QOL score + 33.3 ∗ P < 0.05, 3 months vs. baseline + 33.4 Change in median eating restrictions score + 33.3 ∗ P < 0.05, 3 months vs. baseline + 45.8 ∗ P < 0.05, 3 months vs. baseline Change in median dysphagia score + 44.4 ∗ P < 0.05, 3 months vs. baseline + 55.5 ∗ P < 0.05, 3 months vs. baseline ∗ P < 0.05, 3 months vs. baseline Open table in a new tab

Impact of risk-reducing oophorectomy on quality of life in women at risk for ovarian cancer

1520 Background: Factors associated with quality of life (QOL) changes after risk-reducing salpingo-oopherectomy (RRSO) have not been clearly defined. We report the results of a prospective QOL study among women undergoing RRSO at the Memorial Sloan-Kettering Cancer Center. Methods: 101 women undergoing RRSO between April 2000 and April 2004 were included. Participants completed questionnaires evaluating perceived risk, symptoms, cancer-related worries/distress, sexual function and QOL at baseline, and at 6 and 12 months after RRSO. All questionnaires were adapted from validated, standardized instruments. Instrument score changes over time were evaluated by GLM repeated measures analysis. Results: The median age of the participants was 48y; 62.4% were post- menopausal; 47.5% had a deleterious BRCA mutation; 46.5% had a family history of OC; 73.3% had a personal history of breast cancer. 74.1% reported a perceived lifetime OC risk =25%. Mean total symptom and depression scores at baseline did not differ by menopausal status, BRCA mutation status, personal breast cancer history or OC family history. Menopausal subscale scores were significantly lower at baseline among pre-menopausal women. Baseline mean anxiety/distress scores and cancer-specific distress scores were significantly higher among mutation carriers than non-carriers. Among women who completed all 3 questionnaires (n=60), overall QOL measured by SF36 did not change over time. There was a significant interaction of menopausal status at surgery with the changes in total symptom and menopause subscale scores. There was a significant interaction between mutation status and post-operative decline in anxiety/distress scores. At 6 and 12 months, 24 (36.4%) and 22 (42.3%) of women, respectively, reported a worsened sex life and approximately 15% were dissatisfied with their decision to undergo RRSO. Conclusions: Most women perceived themselves at increased risk of OC and were satisfied with their decision to undergo RRSO. Mutation carriers demonstrated significant baseline OC-specific anxiety, but experienced a significant reduction post-RRSO. A significant increase in symptomatology was reported after RRSO, particularly among pre-menopausal women; however, there was no significant overall change in QOL. No significant financial relationships to disclose.