Completed Quality Of Life Assessments Research Articles

Measuring the effect of the anti-nerve growth factor antibodies bedinvetmab and frunevetmab on quality of life in dogs and cats with osteoarthritis using a validated health-related quality of life outcome measure: an observational real-world study.

Osteoarthritis causes chronic pain, impaired joint function, decreased mobility and negatively impacts quality of life (QOL). Anti-nerve growth factor antibodies bedinvetmab for dogs and frunevetmab for cats are licensed for the alleviation of osteoarthritis pain but their QOL impact is unreported. Our aim was to determine if these therapeutics improve QOL using a validated health-related QOL measure that generates scores in four domains of QOL-energetic and enthusiastic (E/E), happy and content (H/C), active and comfortable (A/C) and calm and relaxed (C/R)-in the dog and three in the cat-vitality, comfort and emotional wellbeing (EWB). Summary scores for physical wellbeing (PWB) and emotional wellbeing (EWB) for dogs and PWB for cats are calculated from the domain scores. Animals received bedinvetmab (dogs) at 0.5-1 mg/kg or frunevetmab (cats) at 1-2.8 mg/kg by subcutaneous injection on days 0, 28 and 56 and owners completed QOL assessments within 48 hours of day 0 and on days 14, 28, 56, 63 and 70 using a study-specific app. Assessments were completed by 75 dog and 56 cat owners. By day 14 there was a statistically significant improvement (p ≤ 0.001) in PWB, EWB and all domains except C/R (p = 0.005) in dogs and in all domains and PWB in the cat. Subsequently there was a continued improvement in all domains and summary scores (p ≤ 0.001) except for H/C in the dog and EWB in the cat, which were excluded from the statistical model. The overall improvement in all domain scores in the cat and E/E and A/C in the dog exceeded the previously reported minimum important difference scores for the QOL measure, indicating a clinically significant change. Treatment with bedinvetmab and frunevetmab produced a significant improvement in the QOL of dogs and cats. This latest evidence for the use of these OA pain medications could be helpful in the clinical management of osteoarthritis and post-marketing clinical trials.

Dosimetric Parameters Correlate with Taste Alterations in Head and Neck Radiotherapy

Dysgeusia is an acute and chronic side effect of head and neck chemoradiation, with persistent taste dysfunction 1-2 years post radiotherapy occurring in 23-50% of patients. Several head and neck clinical trials set oral cavity mean doses between 30 to 40 Gy, however, there are no set guidelines accurately defining the composite structure and anatomic boundaries for the oral cavity or separating the tongue into specific quadrants. In this single institution cross sectional study, we sought to determine the effects of radiation doses to specific regions of the oral cavity and tongue on patient-reported long term dysgeusia. We hypothesize that radiation Dose to specific structures in the oral cavity will correlate with long-term dysgeusia in patients who have received head and neck radiotherapy. Patients with primary head and neck cancer receiving definitive intensity modulated radiation therapy (RT) completed quality of life assessments that included patient-reported gustatory function, 1 year post RT. Dosimetric data from RT plans were collected for specific regions and organs at risk within the oral cavity. These structures included the anterior, posterior, superior and inferior tongue (OT), pharyngeal constrictors (as a surrogate for the corda-tympani) and the oral cavity. A forward binary logistic regression model was performed using these data points with scoring from the QLQ-H&N43 questionnaire subsection on taste (Q45) to determine the most predictive values for dysgeusia and the OR for moderate/severe alterations in taste. A total of 78 patients were included in this study, of these patients, 63 had dosimetric data for the pharyngeal constrictors. The Oral Cavity Volume percentage receiving 50Gy (OC V50) and Pharyngeal Constrictors Volume percentage receiving 55Gy (PC V55) were the most predictive constraints for dysgeusia. (0.042, p = 0.011 and 0.041, p = 0.033). Holding all other variables constant in a forward binary logistic regression including 78 patients, the odds of having moderate to severe taste alterations increased by 56% (OR 1.045, 95% CI 1.012-1.079) for a 1% increase in OCV50. When analyzing the 68 patients with available pharyngeal constrictors data, taste alteration increased 20% for every 1% increase in PCV55 (OR 1.042, 95% CI 1.003-1.082). There was no correlation with taste alterations in any of the dose parameters tested (Dmax, mean and V50 up to V70) for superior, inferior, anterior or posterior regions of the tongue. Dosimetric parameters for the oral cavity (OC V50) and pharyngeal constrictors (PC V55) were positively correlated with taste alterations, however, no other specific regions within the oral tongue predicted taste disfunction. Normal tissue complication probability modeling curves to identify OC V50 and PC V55 constraints for dysgeusia are needed.

Correlation of preference- and profile-based quality of life of Japanese oral cancer patients during the perioperative period measured using EQ-5D-5L and FACT-H&N

The EuroQol 5-dimension 5-level (EQ-5D-5L) instrument is among the most used preference-based quality of life (QOL) measures for cost-utility analysis. Each dimension is evaluated on five levels. The aim of this study was to clarify whether the EQ-5D-5L, which consists of only five items, correlates with profile-based QOL measures in Japanese oral cancer patients during the perioperative period. One hundred participants with oral cancer undergoing radical therapy completed QOL assessments before treatment, at treatment completion, and 1 and 3 months after treatment using the EQ-5D-5L and Functional Assessment of Cancer Therapy - Head & Neck instrument (FACT-H&N, Japanese version). To clarify how the EQ-5D-5L reflects the FACT-H&N, multiple regression analyses were performed using FACT-H&N subscales. The ceiling effect of the EQ-5D-5L was investigated. The EQ-5D-5L moderately correlated with the FACT-H&N over the entire perioperative period (rs = 0.586, P < 0.01). In the multiple regression analysis, the EQ-5D-5L was strongly reflected in the physical wellbeing subscale of the FACT-H&N, excluding social wellbeing. The pre-treatment EQ-5D-5L score was decreased owing to the impacts of the dimensions of pain/discomfort and anxiety/depression. The EQ-5D-5L did not have a ceiling effect in oral cancer patients. The EQ-5D-5L appears to generally correlate with the FACT-H&N for oral cancer patients during the perioperative period.

Comparative analysis of quality of life for three different adjuvant treatment modality in early stage cervical cancer: an analysis from STARS study

<h3>Objectives:</h3> This analysis aimed to compare the quality of life (QoL) of patients with different adjuvant treatment modalities in STARS study for cervical cancer. <h3>Methods:</h3> QoL assessment was done at the baseline and then longitudinally after completing of radiation or chemotherapy assigned in STARS study. In the study, post-operative FIGO stage IB to IIA cervical cancer patients with adverse pathological factors were randomized in 1:1:1 to receive adjuvant radiation alone, concurrent chemoradiation weekly cisplatin or sequential chemoradiation (with cisplatin plus paclitaxel in 21-day cycle, given 2 cycles before and 2 cycles after radiotherapy respectively). QoL was assessed with EORTC QLQ-C30 questionnaires at baseline (1 week after the surgery), during the treatment period (in the 5th week receiving pelvic irradiation), 12 months and 24 months after the completion of treatment. Analysis of variance by one-way repeated measures analyses of variance (ANOVA) was used to compare differences in QoL measures among treatment groups. <h3>Results:</h3> Totally, 816, 633, 360 and 254 patients had completed QoL assessment at baseline, during treatment period, 12 month and 24 month after the completion of treatment. At baseline, a lowest global health status (GH) and functional dimensions including physical, emotional, role, cognitive and social functioning, and lowest scores of symptom and single item scales were presented among the 3 groups with balance (p > 0.05). During treatment period, GH and other functional dimension scores were elevated, with symptom item scores declined in RT group. While in CCRT or SCRT group, an elevated scores of symptom scales including of nausea and vomiting (30.93±25.5 vs 20.8±25.0 in SCRT group, 31.0±28.1 vs 16.5±24.3 in CCRT group), and appetite loss (39.6±30.9 vs 34.8±32.1 in CCRT group) was noted when comparing with that in baseline. The score of item concerning financial difficult declined in CCRT and SCRT group, which was similar as RT group. The scores of GH, functional dimensions and other symptom scales were not different compared with baseline in these two groups. During treatment period, a highest score of global health, functional dimensions including physical, role, cognitive, social functioning, and lowest scores of symptom including fatigue, nausea and vomit, insomnia, appetite loss, constipation and diarrhea was presented in the RT group than the other two groups (GH score 66.5±16.4 in RT group, 60.7±17.9 in CCRT group and 61.9±17.5 in SCRT group, p=0.001). No differences between CCRT and SCRT group regarding GH, functional dimensions and symptom scores. In 12 and 24 months after the completion of treatments, further improved GH, functional dimension scores and declined symptom scores were observed in the whole population, with no significant differences among the 3 treatment groups. <h3>Conclusions:</h3> In CCRT and SCRT group, adding chemotherapy in adjuvant treatment had negative effects on GH, physical, cognitive, social and role function, as well as symptoms related to QoL during the treatment period compared with RT. While the symptoms resolved, functioning and general QoL improved after 12 months of treatment, indicating a transient impact on QoL of patients receiving adjuvant treatment.

Effect of genetic testing results on patient-reported quality of life among patients undergoing panel testing for newly diagnosed ovarian cancer.

1584 Background: This study compared patient-reported stress, anxiety, and depression between newly diagnosed ovarian cancer patients with pathogenic genetic testing results versus patients with non-informative results (i.e., variants of uncertain significance (VUS) or negative). Methods: Patients underwent genetic testing (GT) via a facilitated referral pathway (Frey et al, Gynecol Oncol 2020) through which they were referred for genetic counseling and GT by their gynecologic oncologist within six weeks of diagnosis from 10/2015 to 5/2019. English-speaking patients completed three quality of life (QoL) instruments: Impact of Events Scale (IOES), State-Trait Anxiety Questionnaire (STAI), Hospital Anxiety and Depression Scale (HADS) immediately pre-and post-GT and 6 months post GT. Two-way mixed ANOVA was performed to analyze effect of GT results on QoL over time with significance p &lt; 0.05. Results: One hundred ten patients were enrolled in the pathway and 83 (76%) patients underwent GT. Among these, 15 (18%) had potentially actionable pathogenic mutations ( BRCA1-8, BRCA2-4, MSH2-2, MRE11A-1); 26 (31%) had VUS results; 3 (4%) had both a pathogenic mutation and a VUS result; and 42 (51%) had negative results. Sixty patients (72%) completed QoL assessments pre and post GT, and 37 (44%) patients at 6-9 months post GT. For all patients, GT results did not affect QoL scales across our time points. By mean scores across all-comers, patients demonstrated mild stress at each time point and clinically significant anxiety immediate post-GT. All patients had a statistically significance decrease in HADS depression scores over time from pre-GT to 6 months post-GT (mean score 4.98 vs 2.97, p = 0.020). Patients with VUS had lower HADS mean anxiety scores across time (3.62) compared to patients with pathogenic (7.44) or negative mutations (6.83, p = 0.029). For patients without mutations, there was a significant decrease in clinically significant anxiety by STAI-state score at 6 months (p = 0.002) and a decrease in borderline anxiety by HADS scores at 6 months (p = 0.005). This effect was not present for patients with pathogenic mutations or VUS. Conclusions: A pathogenic result does not impact QoL scales immediately pre or post GT or at 6 months post GT, though patients with negative mutations were more likely to show a decrease in anxiety over time. Patients should be recommended GT at time of diagnosis of ovarian cancer without concern of increased stress, anxiety, or depression based on GT results.

Facilitated referral pathway for genetic testing at the time of ovarian cancer diagnosis: uptake of genetic counseling and testing and impact on patient-reported stress, anxiety and depression

Timely genetic testing at ovarian cancer diagnosis is essential as results impact front line treatment decisions. Our objective was to determine rates of genetic counseling and testing with an expedited genetics referral pathway wherein women with newly-diagnosed ovarian cancer are contacted by a genetics navigator to facilitate genetic counseling. Patients were referred for genetic counseling by their gynecologic oncologist, contacted by a genetics navigator and offered appointments for genetic counseling. Patients completed quality of life (QoL) surveys immediately pre- and post-genetic assessment and 6 months later. The primary outcome was feasibility of this pathway defined by presentation for genetic counseling. From 2015 to 2018, 100 patients were enrolled. Seventy-eight had genetic counseling and 73 testing. Median time from diagnosis to genetic counseling was 34 days (range 10-189). Among patients who underwent testing, 12 (16%) had pathogenic germline mutations (BRCA1-7, BRCA2-4, MSH2-1). Sixty-five patients completed QoL assessments demonstrating stress and anxiety at time of testing, however, scores improved at 6 months. Despite the pathway leveling financial and logistical barriers, patients receiving care at a public hospital were less likely to present for genetic counseling compared to private hospital patients (56% versus 84%, P = 0.021). Facilitated referral to genetic counselors at time of ovarian cancer diagnosis is effective, resulting in high uptake of genetic counseling and testing, and does not demonstrate a long term psychologic toll. Concern about causing additional emotional distress should not deter clinicians from early genetics referral as genetic testing can yield important prognostic and therapeutic information.

Quality of life in pediatric oncology patients, caregivers and siblings after psychosocial screening: a randomized controlled trial.

We evaluated whether conducting psychosocial screening using a validated measure (the Psychosocial Assessment Tool, PAT) and providing a summary of PAT results to the patient's treating team improves quality of life (QOL) in newly diagnosed patients with cancer, their caregivers and siblings, in general, and in relation to the initial family psychosocial risk. Families were randomly allocated to an intervention (IG, treating team received PAT summary describing low, medium, or high psychosocial risk) or control group (CG, no summary provided to treating team) in two Canadian pediatric cancer centers. Caregivers (N = 122) of children newly diagnosed with cancer, patients (n = 36), and siblings (n = 25) completed QOL assessments at 2-4 weeks (T1) and 6 months post-diagnosis (T2). Caregivers also completed PAT and proxy QOL for patient and sibling. In general, patient-proxy total QOL improved in IG compared to CG over time but only for high psychosocial risk patients (p < .05). Patient proxy cancer-related QOL improved over time regardless of group allocation; caregiver QOL also improved over time (ps < .05). This study demonstrated the benefits of psychosocial screening results only on proxy patient QOL outcomes with high psychosocial risk near diagnosis. Evaluating QOL benefits in pediatric oncology patients is critical for establishing the clinical value of psychosocial screening. NCT02788604 (REGISTERED WITH HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT02788604 ).

Quality of life assessment in esophageal atresia patients: a systematic review focusing on long-gap esophageal atresia

Children born with esophageal atresia (EA) have inherent abnormalities in esophageal motility which may impact upon patient and family Quality of Life (QoL). Currently, paucity of data exists for long-term outcomes of long-gap EA. We aimed to: (1) summarize QoL tools reported in the literature, focusing upon studies involving long-gap EA patients, and (2) compare QoL for long-gap versus non-long-gap EA patients. We performed a systematic review of Cochrane Register of Controlled Trials, PubMed, EMBASE, and Ovid databases (January 1980-May 2018) in accordance with the PRISMA protocol. Six studies were identified (536 patients total), and 419/536 (78%) patients completed QoL assessment. Response rates ranged from 29% to 100%. Median study size was 86 (range 8-159). Esophageal atresia type was described in 477 patients, and 74/477 (16%) were long-gap. Common assessment tools were Gastrointestinal Quality of Life Index and 36-Item Short-Form Health Survey. Compared with healthy individuals, long-gap EA patients suffered more gastrointestinal symptoms. There were no significant differences in QoL outcomes between long-gap and non-long-gap EA patients. Current literature suggests no significant difference in QoL outcomes between long-gap and non-long-gap EA patients. However, due to questionnaire variability and range of response rates, the data should be interpreted with care. Level II.

Chiari I malformation-neuropsychological functions and quality of life.

To assess the neuropsychological (NP) functioning and quality of life (QOL) before and 3months after surgery on adults with Chiari I malformation (CMI). All adult patients who had been diagnosed with CMI were invited to participate. Those who participated were assessed using a Hospital Anxiety and Depression scale (HAD) and NP examinations. Their QOL was assessed using the self-reported life satisfaction checklist, LiSat-11 and the five-dimensional EuroQol measurement of health outcome, EQ-5D-5L. All assessments were carried out both before and 3months after surgery was performed. Demographic data and comorbidities were also registered. Of the 11 patients who underwent NP assessment, the majority demonstrated cognitive functioning within the normal range. However, postoperatively, their performance in verbal learning, psychomotor speed, colour naming speed and the ability to manage interference through response selection and inhibition (aspects of executive functioning) was significantly improved. Thirteen patients completed QOL assessments. When LiSat-11 item domains were compared with those of healthy subjects, patients reported a lower level of satisfaction with their life quality both before and after surgery. However, the EQ-5D-5L measurements, i.e., the descriptive system and the visual analogue, indicated that their QOL of life was significantly improved after surgery. There is scarcely any literature documenting effects of surgery on the QOL of CMI patients. The study we present here breaks new ground by comparing pre- and postoperative NP functions in CMI. We also examine the value of surgery for improving both NP functions and QOL in CMI.

The relationship of Type 1 diabetes self-management barriers to child and parent quality of life: a US cross-sectional study.

Families of children and adolescents with Type 1 diabetes experience self-management challenges that negatively impact diabetes control. This study assesses whether self-management challenges are also associated with quality of life (QOL) for children and adolescents with Type 1 diabetes and their parents. Children aged 8-12 years (n = 135), adolescents aged 13-16 years (n = 132) and their parents completed QOL assessments (diabetes-specific QOL from the PedsQL Diabetes Module or the Family Impact Module, both scaled 0-100) and a validated survey of up to six self-management barriers [PRISM; scaled 1 (low) to 5 (high)]. Regression coefficients were calculated to assess the association of self-management barriers with child and adolescent diabetes-specific QOL or parent QOL, including interaction effects to assess the stability of the associations. Mean duration of diabetes was 4.7 years for children and 6.1 years for adolescents. The majority of children and adolescents did not meet target values for glycaemic control. All barriers but one (Healthcare Team Interactions) were associated with lower diabetes-specific QOL for children and adolescents, as well as lower QOL for parents (all P < 0.05). Barrier scores that were 1 unit higher were associated with diabetes-specific QOL that was 3.7-5.1 points lower for children and 5.8-8.8 points lower for adolescents, as well as QOL that was 6.0-12.6 points lower for parents. Diabetes-specific QOL was most strongly associated with 'Denial of Disease and Its Consequences' for children and with 'Regimen Pain and Bother' for adolescents. Parent QOL was most strongly associated with 'Understanding and Organizing Care'. Associations were stable across numerous demographic and disease factors. Single-unit differences in self-management barrier scores are associated with clinically meaningful differences in QOL for children and parents. Interventions specifically tailored to address individual self-management barriers may improve both diabetes control and QOL.

A comparative analysis of quality of life after postoperative intensity-modulated radiotherapy or three-dimensional conformal radiotherapy for cervical cancer

The aim of this study is to compare the quality of life (QOL) between adjuvant three-dimensional conformal radiotherapy (3DCRT) or intensity-modulated radiotherapy (IMRT) for cervical cancer. QOL assessment was done at the baseline and then longitudinally after completing (chemo) radiation. All patients completed EORTC QLQ-C30 and EORTC QLQ Cx-24 modules. Independent-sample t-test was used to compare the mean scores between the two groups. Analysis of variance was used to compare differences in QOL measures over the six time points (baseline, post-RT, 3, 6, 9, and 12 months after treatment) and between treatment groups (3DCRT vs. IMRT). Linear mixed model was also performed to account for attrition. Overall, 64 patients (image-guided IMRT, n = 40 and 3DCRT, n = 24) completed QOL assessment. The median age and follow-up period were 48 years and 15.5 months, respectively. General QOL domains such as emotional (at 12 months, P = 0.04) and social (at 3 months, P = 0.02 and 12 months, P = 0.03) were better with IMRT. Pain (12 months, P = 0.03); fatigue (12 months, P = 0.05); nausea and vomiting (12 months, P = 0.03); insomnia (post-RT, P = 0.05 and 12 months, P = 0.03); appetite loss (post-RT and 12 months, P = 0.04); and diarrhea (6 months, P = 0.02 and 12 months, P = 0.003) scores were significantly better with IMRT. On linear mixed model analysis, there was a significant interaction between treatment cohort and assessment intervals for physical, emotional, and social functioning, appetite loss, diarrhea, lymphedema, and menopausal symptom scores were significantly better with IMRT. Treatment technique (IMRT vs. 3DCRT) impacts early QOL in undergoing adjuvant radiation for cervical cancer.

Health-Related Quality of Life After Transcatheter Aortic Valve Implantation in Elderly Patients With Severe Aortic Stenosis

Severe aortic stenosis may affect both normal daily living and survival. Transcatheter aortic valve implantation (TAVI) has become an appropriate alternative to surgery for elderly patients with high surgical risk, and it results in improved survival in this population. To describe health-related quality of life (QoL) before, and at 1 and 6 months after TAVI. Cardiovascular Department, Toulouse University Hospital, France. One hundred sixty-four consecutive patients with at least 6 months follow-up who underwent TAVI in our institution between February 2009 and June 2011 were enrolled in the study. Of this population, 73 (mean age: 82.3 ± 7.3 years, 56% men) completed QoL assessment using the EuroQOL Five Dimensions (EQ-5D) questionnaire and a visual analogue scale at baseline, and at 1 and 6 months. At each visit, medical data and New York Heart Association functional class were collected. The median preprocedure EQ-5D index value (interquartile range) was 0.66 (range, 0.36-0.78) showing severely impaired QoL in almost all patients. Significant improvement occurred from baseline to 1 month of follow-up in EQ-5D index value [0.73 (range, 0.59-0.79)] and this was maintained at 0.73 (range, 0.62-0.81) at 6 months. The improvement was significant for 3 dimensions of the EQ-5D score at the 6-month follow-up: usual activities in 43.8% of patients (P < .001); anxiety/depression in 37% (P < .001) and pain/discomfort in 28.8% (P < .05). Mean New York Heart Association class improved significantly from 3.24 at baseline to 2.04 at 1 month and 1.89 at 6 months. In high-risk patients with severe aortic stenosis, QoL and health status improved substantially at 1 month and improvement persisted 6 months after TAVI.

Abstract P6-08-04: Prognostic significance of quality-of-life scores in early stage and relapsed breast cancer: Results from seven randomized trials of the International breast cancer study group

Abstract We performed an individual patient meta-analysis to investigate the prognostic value of patient self-reported quality-of-life (QL) scores at baseline, and at several times prior to and following disease relapse on subsequent overall survival (OS) in seven randomized trials of the International Breast Cancer Study Group. Patients with early stage breast cancer who participated in randomized trials that compared adjuvant therapies, and who had subsequent disease relapse, completed QL assessments for physical well-being, mood, appetite, nausea and vomiting, arm swelling, flushing, coping effort, and utility at study entry, prior to and after disease relapse. We tested the relationships between baseline QL scores and OS using Cox regression analyses. We performed landmark analyses to assess the relationships between pre-relapse QL scores with OS using QL assessments at 1, 2 and 3 months prior to disease relapse, at the time of relapse and at two subsequent QL assessments where these were available. All Cox models were stratified by trial and included other factors related to QL and/or outcome. Among 8,024 patients, 3,834 (48%) had disease relapse after a median follow-up time of 12 years. Amongst these patients, QL score at baseline, and at 1, 2, and 3 months prior disease relapse were not significantly prognostic for OS. At disease relapse, scores for physical well-being (hazards ratio [HR] per 10 unit increase of QL score for death, 1.05; P = 0.003), mood (HR 1.05; P = 0.007), appetite (HR 1.08; P&amp;lt;0.001), and utility (HR 1.13; P = 0.008) were prognostic for subsequent OS. Nausea and vomiting (HR 1.05; P = 0.11), arm swelling (HR 1.00; P = 0.20), flushing (HR 1.01; P = 0.73), and coping effort (HR 1.02; P = 0.29) were not prognostic for subsequent OS. At post-relapse assessments at median times of 1 (HR 1.07; P&amp;lt;0.001), 6 (HR 1.08; P&amp;lt;0.001) and 10 months (HR 1.13; P&amp;lt;0.001) after disease relapse, scores for physical well-being showed increasing prognostic significance. Scores for mood, nausea and vomiting, appetite, coping effort and utility showed patterns similar to those for physical wellbeing, but scores for arm swelling and flushing were not prognostic for subsequent OS. These findings confirm and extend those of Coates et al. (J Clin Oncol 2000;18:3768 - 3774) based on two of the trials included in the present analysis. At baseline and prior to relapse, QL scores did not have any prognostic significance for subsequent OS. At and after disease relapse, QL scores substantially predicted for subsequent OS, with stronger association for QL scores later in the course of relapsed disease. Patient perception of the severity of underlying illness after relapse might be a potential reason that determines the reported QL scores and thus contributes to their prognostic significance. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P6-08-04.

Marital Status and Quality of Life in Patients with Esophageal Cancer or Barrett's Esophagus: The Mayo Clinic Esophageal Adenocarcinoma and Barrett’s Esophagus Registry Study

Patients with esophageal carcinoma (EC) report deficits in quality of life (QOL), depending on the extent of malignant disease and the goals of treatment at the time of QOL measurement. To quantify the association of marital status and changes in QOL over time in patients with EC and patients with Barrett's esophagus (BE). Eligible patients in the Mayo Clinic Esophageal Adenocarcinoma and Barrett's Esophagus Registry completed QOL assessments at baseline and approximately 1 year later. QOL was determined with a ten-point linear analog self-assessment scale evaluating overall QOL and 12 subscales. Overall, 489 BE patients and 212 EC patients were evaluated. Married EC patients reported higher baseline QOL in legal concerns (8.1 vs. 7.1; p = .04) and friend and family support (9.3 vs. 8.4; p = .02) than single EC patients. Over time, married EC patients had a decrease in pain frequency QOL compared to single EC patients (-0.9 vs. +0.6; p = .02), with other QOL measures being stable. Married BE patients showed higher social activity QOL at baseline than single BE patients (7.5 vs. 6.9; p = .02); QOL was stable over time between the marital status groups. Minor, but statistically significant, changes were reported regarding QOL in two categories at baseline and over time among married and single patients with EC. Minor differences may be present between married and single EC patients regarding spiritual QOL at baseline and in overall physical well-being QOL at baseline and over time, although these differences did not reach statistical significance.

A cost-minimisation analysis of lobectomy: thoracoscopic versus posterolateral thoracotomy☆

Recent evidence suggests that lobectomy performed either through thoracoscopy (TL) or via a posterolateral thoracotomy (PLT) produces equivalent oncologic outcomes in appropriately selected patients. Advantages of thoracoscopic lobectomy include decreased postoperative pain, shorter length of stay, fewer postoperative complications and better compliance with adjuvant chemotherapy. This study evaluates the costs associated with lobectomy performed thoracoscopically or via thoracotomy. This is a retrospective analysis of actual costing and prospectively collected health-related quality of life (QOL) outcomes. Between 2002 and 2004, 113 patients underwent lobectomy (PLT: n=37; TL: n=76) and completed QOL assessments both preoperatively and 1-year postoperatively. Actual fixed and variable direct costs from the preoperative, hospitalisation and 30-day postoperative phases were captured using a T1 cost accounting system and were combined with actual professional collections. Cost-utility analysis was performed by transforming a global QOL measurement to an estimate of utility and calculating a quality-adjusted life year (QALY) for each patient. Baseline characteristics were similar in the two groups. Total costs (USD) were significantly greater for the strategy of PLT (USD 12,119) than for TL (USD 10,084; p=0.0012). Even when only stage I and II lung cancers were included (n=32 PLT, n=69 TL), total costs for PLT were still higher than that for TL (USD 11,998 vs USD 10,120; p=0.005). The mean QALY for the PLT group was 0.74+/-0.22 and for the TL group was 0.72+/-0.18 (p=0.68). In this retrospective analysis, TL was significantly less expensive than PLT from the preoperative evaluation through 30 days postoperatively, with overall savings of approximately USD 2000 per patient. In light of equivalent QALY outcomes, this cost-utility analysis supports increased adoption of TL as a cost-minimisation strategy. The use of TL for the 50,000 lobectomies performed in the United States each year would represent a savings of approximately USD 100 million.

Quality of Life of Patients With Endometrial Cancer Undergoing Laparoscopic International Federation of Gynecology and Obstetrics Staging Compared With Laparotomy: A Gynecologic Oncology Group Study

The study's objective was to compare the quality of life (QoL) of patients with endometrial cancer undergoing surgical staging via laparoscopy versus laparotomy. The first 802 eligible patients (laparoscopy, n = 535; laparotomy, n = 267) participated in the QoL study in a Gynecologic Oncology Group (GOG) randomized trial of laparoscopy versus laparotomy (GOG 2222). Patients completed QoL assessments at baseline; at 1, 3, and 6 weeks; and at 6 months postsurgery. In an intent-to-treat analysis, laparoscopy patients reported significantly higher Functional Assessment of Cancer Therapy-General (FACT-G) scores (P = .001), better physical functioning (P = .006), better body image (BI; P < .001), less pain (P < .001) and its interference with QoL (P < .001), and an earlier resumption of normal activities (P = .003) and return to work (P = .04) over the 6-week postsurgery period, as compared with laparotomy patients. However, the differences in BI and return to work between groups were modest, and the adjusted FACT-G scores did not meet the minimally important difference (MID) between the two surgical arms over 6 weeks. By 6 months, except for better BI in laparoscopy patients (P < .001), the difference in QoL between the two surgical techniques was not statistically significant. Although the FACT-G did not show a MID between the two surgical groups, and only modest differences in return to work and BI were found between the two groups, statistically significantly better QoL across many parameters in the laparoscopy arm at 6 weeks provides modest support for the QoL advantage of using laparoscopy to stage patients with early endometrial cancer.

The prognostic effects of performance status (PS) and quality of life (QoL) scores on progression-free survival (PFS) and overall survival (OS) in advanced ovarian cancer

5066 Background: Performance status is an important prognostic factor in advanced ovarian cancer. We sought to evaluate the relationship between PS and EORTC QLQ-C30 QoL scores and the PFS and OS in advanced ovarian cancer. Methods: Canadian data was analyzed as part of an intergroup randomized trial in ovarian cancer (NCIC-OV10). Patients were randomized to receive either standard chemotherapy using cisplatin/cyclophosphamide or cisplatin/paclitaxel chemotherapy. The EORTC QoL questionnaire QLQ-C30 was administered just prior to starting chemotherapy, at each cycle, and every 3 months thereafter for two years or until disease progression. We determined PS and QoL scores in the following domains: physical, role, emotion, cognitive, social function and global QoL at baseline and 6 months after completing chemotherapy. Effects of multiple variables including treatment, PS, QoL scores, age, stage, grade, residual disease and histology were analyzed by Cox stepwise regression using PFS and OS as the outcome variables. Results: At baseline and at 6 months after chemotherapy, there were 151 and 80 patients respectively who completed QoL assessments. The Cox model revealed that baseline PS, global QoL and treatment were independent predictors for both PFS and OS, and grade and cognitive functioning were additional independent predictors for OS. Physical function at six months after completion of chemotherapy was the only significant independent predictor of both PFS and OS, with age and grade as two additional independent predictors for subsequent OS. Conclusions: Performance status and global quality of life scores at baseline are prognostic factors in advanced ovarian cancer for both PFS and OS. Higher baseline cognitive functioning scores were also associated with improved survival. Higher physical function scores at six months after completing chemotherapy predicted longer PFS and OS. (This research was supported by the NCIC through funds received by the Canadian Cancer Society). No significant financial relationships to disclose.

Quality of life scores predict outcome in metastatic but not in early breast cancer

SUMMARY We compared the prognostic value of quality of life (QL) scores in the adjuvant setting and after relapse in two randomized trials of the International Breast Cancer Study Group (IBCSG). More than 2000 premenopausal and postmenopausal patients with node-positive breast cancer participating in randomized trials comparing adjuvant therapies completed QL assessments for physical wellbeing (PWB), mood, appetite and coping at study entry, at months 3 and 18 if they remained relapse-free, and at 1 month and at 6 months after relapse. Cox regression models were used to test the relationship between QL scores and disease-free survival (DFS) in the adjuvant setting, or overall survival in the case of post-relapse QL measurement. All models were stratified by language/country group and included other factors related to QL and/or outcome. DFS was not significantly predicted by QL scores at baseline or month 18, or by changes in QL score between baseline and months 3 or 18. In contrast, after relapse, QL scores were predictive for subsequent overall survival. One month after relapse, better mood (P = 0.04) was associated with longer survival in premenopausal patients, and better appetite (P = 0.005) in postmenopausal patients. Six months after relapse, PWB (P = 0.03) and appetite (P = 0.03) were predictive for survival in premenopausal, and PWB (P Any prognostic significance of QL scores in the adjuvant setting is minimal or obscured by chemotherapy effects, but there is strong prognostic significance after disease relapse. The contrast suggests that patient perception of the severity of underlying illness may determine reported QL scores.