Linear Analogue Self-assessment Scales Research Articles

Wellbeing of Frontline Health Care Workers After the First SARS-CoV-2 Pandemic Surge at a Neuroscience Centre: A Cross-sectional Survey

Background:The coronavirus disease 2019 (COVID-19) pandemic has affected people of all ages, races, and socioeconomic groups, and placed extraordinary stress on health care workers (HCWs). We measured the prevalence of burnout and assessed wellbeing and quality of life (QoL) in HCWs at a single UK neuroscience center after the first pandemic surge.Methods:A 38-item electronic questionnaire was disseminated through local team email lists between May 22 and June 7, 2020, to HCWs in a university neurosciences center. Burnout was measured using the single-item Emotional Exhaustion and Depersonalization scales, and wellbeing and QoL assessed using the Linear Analogue Self-Assessment Scale and the EuroQol-5 Dimension instrument.Results:The response rate was 57.4% (n=234); 58.2% of respondents were nurses, 69.4% were women and 40.1% were aged 25 to 34 years. Overall, 21.4% of respondents reported burnout assessed by the Emotional Exhaustion scale; burnout was higher for nurses (23.5%) and allied health care professionals (22.5%) compared with doctors (16.4%). HCWs from ethnic minority groups reported a higher rate of burnout (24.5%) compared with white HCWs (15.0%). There were no differences in reported wellbeing or QoL between professional groups, or HCW age, sex, or race. Nurses (36.8%) and staff from ethnic minority groups (34.6%) were more fearful for their health than others.Conclusions:Our findings highlight the prevalence of HCW burnout after the first surge of the pandemic, with an increased risk of burnout among nurses and staff from ethnic minority groups. Both nursing and staff from ethnic minority groups were also more fearful for their health. With ongoing pandemic surges, the impact on HCW wellbeing should be continuously assessed to ensure that local strategies to support staff wellbeing are diverse and inclusive.

Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events and Quality-of-Life Linear Analogue Self-Assessment in Breast Cancer Patients Receiving Radiation Therapy: Single-Institution Prospective Registry

We sought to investigate the impact of Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) on overall quality-of-life (QOL) employing Linear Analogue Self-Assessment (LASA) in breast cancer (BC) patients undergoing radiation therapy (RT) in a single-institution prospective registry. All patients treated with RT for BC with curative intent from 2015 to 2019 at our institution were eligible for this analysis. Breast specific PRO-CTCAE and overall LASA QOL questionnaires were administered at baseline, end-of-treatment, 3, 6, 12 months, and then annually. A patient was considered to have patient-reported treatment-related symptomatic AEs (PAE) at each time-point, if she had a score of 3 or higher (“severe” or worse) for any breast specific PRO-CTCAE item that was higher than baseline. Minimal clinical difference in overall QOL was considered to be a 10-point change in LASA score. Hypofractionation was defined as any treatment >2 Gy per fraction. Repeated measures mixed models were used to determine the effect PRO-CTCAE had on overall QOL based on LASA. Three-hundred and two (392) patients with a median follow-up of 2.3 years (range, 0.4–3.9) were included for analysis. Patient and treatment characteristics included: 8% pT0, 15% pTis, 50% pT1, 21% pT2, 6% pT3, 63% pN0, 17% pN1, 6% pN2, 3% pN3, 11% pN not reported, 81% ER+, 77% PR+, 11% HER2+, 65% ECOG 0, and median body mass index (BMI) 27.3 (range, 16.4 – 53.8). Treatment characteristics included: median dose 40.05 Gy (range, 40–50.4 Gy), 74% treated with hypofractionation, 42% received a boost (median 10 Gy, range 5.4–12 Gy), 86% treated with photons, 14% treated with proton beam therapy, 76% underwent lumpectomy, and 41% received chemotherapy. Average overall QOL LASA scores for all patients were 78.5 at baseline, 79.8 at end of treatment, 79.8 at 3 months, 77.1 at 6 months, 79.4 at 12 months, and 79.7 at 24 months. On univariate analysis, patients who reported a PAE had, on average, a 9.8-point reduction in overall LASA QOL (p<.0001). On multivariate analysis, not being treated with hypofractionation and higher BMI were predictive for worse overall LASA QOL with a 9.5-point reduction in LASA for patients who reported a PAE (p<.0001). While average overall QOL according to LASA did not change during follow-up for all patients treated with curative intend RT for BC, patients who reported a worsening breast-specific PRO-CTCAE item to “severe” or worse experienced statistically significant and clinically meaningful deterioration in overall QOL based on LASA scale. The use of hypofractionation significantly improved overall QOL while higher BMI predicted for worse QOL. These results contribute to the understanding of PRO-CTCAE for breast cancer patients and promote the value of integration of PRO-CTCAE items into future clinical trials.

Identifying Potential Associations Between Patient Reported Outcomes and Normal Structure Dose Metrics in Head and Neck Cancer Patients Using a Big Data Approach

Including patient reported outcomes (PROs) as data elements automatically aggregated into Big Data Analytics Resource Systems (BDARS) generates vast amounts of data linking potential associations of PRO responses to other key data elements. Extracting clinically useful insights from these associations helps demonstrate value in collection of PROs. A challenge in analysis of the large volume of potential associations is development of statistical filters identifying associations that are both clinically and statistically significant. In this study, we examined associations between PROs and normal tissue dose measures from head and neck cancer patients, then applied statistical filters to identify those most likely to be clinically relevant. Two hundred sixty-two head and neck cancer patients previously treated in our department, who had completed PRO questionnaires at follow-up appointments, and had available normal tissue dose measures were included in the study. The PRO questionnaires included the University of Washington QOL Questionnaire (UW-QOL), University of Michigan Xerostomia Questionnaire (XQ), and pain, fatigue and overall quality of life components from the Linear Analogue Self-Assessment scale (LASA-3). Using a big data approach, we analyzed interactions between each of the individual PROs from these questionnaires and mean and maximum doses from all pertinent normal structures. For each combination of PRO and dose measure, statistical metrics (AUC, PPV, NPV, sensitivity, p-value) were generated using all possible PRO response cutoffs to separate positive from negative outcomes. Filters for each of these metrics were applied individually and in combination, and the remaining number of PRO responses and normal structure dose pairs for a given cutoff (result pairs) at each iteration were calculated. A total of 4680 result pairs were identified for both mean and maximum dose. Using an AUC filter of 0.65 and dose cutoffs of 24 Gy for mean dose and 45 Gy for max dose returned 82 result pairs for mean dose and 69 result pairs for max dose. Additional filters including sensitivity of 0.50, positive predictive value of 0.1, negative predictive value of 0.5, and p-value of 0.02 reduced the remaining result pairs to 20 and 25, respectively, for mean dose and maximum dose. Of this total of 45 result pairs, 22 involved submandibular gland doses and one involved parotid gland dose. Associations between brainstem dose measures and activity and overall quality of life were also noted, although only for the lowest PRO response cutoffs. Applying statistical metric filters to all combinations of PRO responses and normal structure dose measure pairs identified a manageable group of result pairs for further investigation. In this hypothesis-generating study, a stronger association was noted between PROs and submandibular gland doses than parotid gland doses in patient treated for head and heck cancers.

Big Data Analysis of Associations Between Patient Reported Outcomes and Physician Reported Toxicities in Head and Neck Cancer Patients Treated with Radiation Therapy

Patient reported outcomes (PROs) from cancer patients provide valuable information related to treatment toxicities and overall quality of life, but can be cumbersome and repetitive. The goal of this study was to analyze patient responses across a variety of PRO questionnaires, to determine factors most strongly associated with quality of life and with physician reported adverse events, as a step towards designing an efficient and informative method of patient reporting in a radiation oncology clinic. We designed a one year pilot study in which 385 head and neck cancer patients treated in our department completed three separate PRO questionnaires (total 27 questions): University of Washington QOL Questionnaire (UW-QOL), University of Michigan Xerostomia questionnaire (XQ), and overall quality of life, pain and fatigue components from the Linear Analogue Self-Assessment scale (LASA-3), at a total of 675 office visits. Patients were asked the questions by MAs at visit rooming and answers were entered into the EMR. Using a big data approach, we analyzed interactions among all components of the PRO responses and between PROs and physician reported adverse events using both Pearson (ρ) and Kendall (τ) correlation coefficients. Factors showing strongest association with quality of life and adverse events were identified for potential inclusion in prospective patient reporting. Patient responses to general pain from UW-QOL and severity of pain from LASA-3 were somewhat highly correlated (ρ=0.73, τ=0.65), and suggest an approximate baseline for response consistency. Similar or greater correlation was found between: mucus and phlegm consistency and amount from UW-QOL (ρ=0.84, τ=0.77), activity and recreation/entertainment from UW-QOL (ρ=0.75, τ=0.68), eating/chewing and eating/swallowing from UW-QOL (ρ=0.71, τ=0.53), and multiple mouth/throat dryness related responses from XQ, with coefficients up to (ρ=0.85, τ=0.74). Factors shown to be most highly associated with overall quality of life included recreation/entertainment (ρ=-0.66, τ=-0.55), activity (ρ=-0.60, τ=-0.49), fatigue (ρ=-0.57, τ=-0.46), severity of pain (ρ=-0.45, τ=-0.38), and pain-general (ρ=-0.42, τ=-0.39). Correlation between physician reported adverse events and PROs were generally low with a maximum of (ρ=0.41, τ=0.34) for dysphagia and eating/swallowing from UW-QOL. Several PROs were highly correlated, suggesting that adequate information could potentially be obtained from shorter and less time-intensive surveys. PROs were not strongly associated with physician reported toxicities. Patient reported activity, lifestyle and fatigue showed stronger correlations with overall quality of life than did pain, and should be included in PRO questionnaires and discussed in office visits. This information is being used to help design informative yet judicious PRO questionnaires and adverse event reporting in our department.

Normative data and clinically significant effect sizes for single-item numerical linear analogue self-assessment (LASA) scales.

BackgroundSingle-item assessments have been the most often-used measures in National Cancer Institute (NCI) cancer control clinical trials, but normative data are not available. Our objective was to examine the normative data and clinically significant effect sizes for single-item numerical linear analogue self-assessment (LASA) scale for overall quality of life (QOL).MethodsWe analyzed baseline data from 36 clinical trials and 6 observational studies with various populations, including healthy volunteers, cancer trial patients (patients with advanced incurable cancer or patients receiving treatment with curative intent) and hospice patients as well as their caregivers. The overall QOL LASA was rated 0 (as bad as it can be) to 10 (as good as it can be). We calculated the summary statistics and the proportion of patients reporting a clinically meaningful deficit (CMD) of a score equal to 5 or less on the 0–10 scale.ResultsIn total, for the collective sample of 9,295 individuals, the average overall QOL reported was 7.39 (SD = 2.11) with a markedly skewed distribution with roughly 17% reporting a score of 5 or below indicating a clinically significant deficit in overall QOL. Hospice patients report a much worse average score of 5.7 upon entry to hospice; hospice caregivers average 7.4. Cancer patients vary within these two extremes with most patients averaging in the 7’s on the 0–10 scale (range, 0 to 10 p-value < 0.0001). Men and women’s QOL distributions were virtually identical (with average of 7.6 vs. 7.5, p-value = 0.046). Overall QOL was weakly related to performance status with a Spearman correlation coefficient of −0.29 (p-value < 0.0001). Overall QOL was related to tumor response (p-value = 0.0094), i.e. patients with a full or partial response reported a CMD in 11.4% of cases compared to 14.4% among those with stable disease and 18.5% among those with disease progression. Data missingness was high for performance status and tumor response associations.ConclusionsThis study provides the normative data for cancer patients and healthy volunteers for overall QOL using the LASA. These can serve as benchmarks for future studies and inform clinical practice decision-making.Electronic supplementary materialThe online version of this article (doi:10.1186/s12955-014-0187-z) contains supplementary material, which is available to authorized users.

Initial Quality of Life (QOL) Deficit Is Related to Decreased Survival in Esophageal Cancer (EC): Final Report of 840 Consecutive Patients Prospectively Evaluated by the Single-Institutional Romero Registry

Results: A total of 898 patients were included. At 2 years, we had data for over 94% of patients. At the early time point 54% of patients had a change in QOL summary that was a MDD or greater for bowel, 37% for urinary incontinence, 78% for urinary obstruction, and 42% for sexual function. At 2 years, a MDD was noted in 29%, 24%, 36%, and 47% for bowel, urinary incontinence, urinary obstruction, and sexual domains, respectively. For those with less than a MDD at the early time, the proportion with MDD at 2 years was 19%, 15%, 14%, and 31%. On MVA, after controlling for age, baseline QOL, PSA, Gleason score, T-stage, prostate volume, and RT technique, an early MDD was the strongest predictor of MDD at 2 years in all domains: OR Z 2.4 [95% CI Z 1.6-3.5] for bowel, OR Z 4.5 [95% CI Z 2.9-6.9] for urinary incontinence, OR Z 3.7 [95% CI Z 2.2-6.4] for urinary irritation, and OR Z 3.7 [95% CI Z 2.55.5] for sexual function. Conclusions: Early QOL decline was the strongest predictor of QOL impacts at 2 years in all domains across multiple RT treatment types. These data require external validation, but are suggestive that early QOL declines may be a viable surrogate for 2 year QOL in future studies. Author Disclosure: S. Zhao: None. J.R. Evans: None. S. DaignaultNewton: None. M.G. Sanda: None. J. Michalski: None. H.M. Sandler: None. D.A. Kuban: None. J.P. Ciezki: None. I.D. Kaplan: None. A.L. Zietman: None. F.Y. Feng: None. L. Hembroff: None. S. Suy: None. C.A. Mantz: A. Employee; 21st Century Oncology. S. Collins: G. Consultant; Accuray. D.A. Hamstra: None.

Evaluation of Clinical Application on Quality of Life of 46 Systematic Reviews from the Cochrane Breast Cancer Group

ABSTRACT Aim: To assess the practical application of quality of life (QoL) in 46 systematic reviews of the Cochrane Breast Cancer Group (in the Cochrane Library) and to identify QoL instruments that have been validated and used in these patients. Methods: We directly included 46 systematic reviews from the Cochrane Breast Cancer Group (from 2000 to 2013). We extracted the following information: study characteristics, usage of QoL (including whether QoL was a primary end-point and whether QoL is or is not mentioned in the abstract), QoL instruments, methodology of QoL assessment and statistical analysis. Results: In the 46 systematic reviews, 543 randomised trials were included. Eight studies did not mention QoL in the full text, accounting for 17%. 19 studies (41%) were identified that reported QoL in the abstract, and 27 (59%) did not. There were 5 studies in which QoL served as primary outcome, 20 as secondary outcome, and 13 as an outcome. About 38 types of instruments were used to evaluate QoL. Most of the studies utilized two or more QoL instruments to assess different aspects of QoL in breast cancer. EORTC QLQ C-30 was the most frequently used, accounting for 27(92%).The second was the FACT, about 11 (46%), then was the SF-36, Linear Analogue Self assessment scales( LASA), and Hospital Anxiety and Depression Scale (HADS) all respectively accounted for 5 (21%). Conclusions: It is concluded that the implementation of QoL assessments into clinical practice for breast cancer is not receiving enough attention. Also the instruments used to evaluate the QoL were varied and which tools would benefit patients is discussed. But there is no doubt that QoL will become an important development direction to evaluate health in the future. Disclosure: All authors have declared no conflicts of interest.

Stress Management and Resiliency Training (SMART) Program among Department of Radiology Faculty: A Pilot Randomized Clinical Trial

To test the efficacy of a Stress Management and Resiliency Training (SMART) program for decreasing stress and anxiety and improving resilience and quality of life among Department of Radiology physicians. The study was approved by the institutional review board. A total of 26 Department of Radiology physicians were randomized in a single-blind trial to either the SMART program or a wait-list control arm for 12 weeks. The program involved a single 90-min group session in the SMART training with two follow-up phone calls. Primary outcomes measured at baseline and week 12 included the Perceived Stress Scale, Linear Analog Self-Assessment Scale, Mindful Attention Awareness Scale, and Connor-Davidson Resilience Scale. A total of 22 physicians completed the study. A statistically significant improvement in perceived stress, anxiety, quality of life, and mindfulness at 12 weeks was observed in the study arm compared to the wait-list control arm; resilience also improved in the active arm, but the changes were not statistically significant when compared to the control arm. A single session to decrease stress among radiologists using the SMART program is feasible. Furthermore, the intervention afforded statistically significant and clinically meaningful improvement in anxiety, stress, quality of life, and mindful attention. Further studies including larger sample size and longer follow-up are warranted.

Normative data and clinically significant effect sizes for single-item numerical linear analogue self-assessment (LASA) scales.

e17619 Background: To provide normative data for the single-item numerical linear analogue self-assessment (LASA) scale for overall quality of life (QOL). Methods: We analyzed baseline data from 36...

Quality of Life After Sipuleucel-T Therapy: Results From a Randomized, Double-blind Study in Patients With Androgen-dependent Prostate Cancer

To collect and analyze quality-of-life (QOL) data from PROvenge Treatment and Early Cancer Treatment trial (PROTECT, NCT00779402), a phase III, randomized controlled trial of sipuleucel-T in patients with asymptomatic androgen-dependent prostate cancer. Patients experiencing prostate-specific antigen relapse after radical prostatectomy entered a 3- to 4-month run-in phase of androgen-deprivation therapy (ADT), followed by 2:1 randomization to sipuleucel-T or control. QOL was assessed throughout the run-in and 26-week post-randomization phases using the Brief Fatigue Inventory (BFI), Linear Analog Self-Assessment (LASA) scale, Global Rating of Change (GRoC) scale, and an elicited symptoms list. One hundred seventy-six patients were randomized into 2 groups, the sipuleucel-T group (n = 117) or the control group (n = 59). The sample provided 80% power to detect a difference in fatigue interference score between treatment arms of 0.9 points. QOL declined predictably during ADT. At week 26, 26.2% of sipuleucel-T-treated patients and 21.6% of control-treated patients (P = .68) reported fatigue in the previous week, and the mean score for fatigue interference in the past 24 hours was 0.9 for both arms (P = .88). Results were comparable for usual fatigue (P = .91) and worst fatigue (P >.99). Mean LASA scores decreased in both groups (P = .26). The proportion of patients reporting better overall QOL on GRoC was similar (P = .62). There is no clinically significant negative impact on QOL after sipuleucel-T treatment compared with control after a period of ADT in patients with asymptomatic androgen-dependent prostate cancer.

Feasibility and effect of chair massage offered to nurses during work hours on stress-related symptoms: A pilot study

This study assessed feasibility and effect of weekly, 15-min chair massages during work for 38 nurses. Mean Perceived Stress Scale-14 (PSS-14), Smith Anxiety Scale (SAS), linear analog self-assessment scale (LASA), and symptom visual analog scale (SX-VAS) scores were tracked at baseline, 5 weeks, and 10 weeks. Of 400 available massage appointments, 329 were used. At 10 weeks, mean PSS-14 score decreased from 17.85 to 14.92 (P = .002); mean SAS score, from 49.45 to 40.95 (P < .001). Mean LASA score increased from 42.39 to 44.84 (P = .006); mean SX-VAS score, from 65.03 to 74.47 (P < .001). Massages for nurses during work hours reduced stress-related symptoms.

Perceived Cognitive Function and Related Factors in Korean Women With Breast Cancer

The aim of this study was to explore perceived cognitive function and its related factors in breast cancer patients that had received or were receiving adjuvant chemotherapy after surgery. A cross-sectional and correlational design was used in this study. A total of 118 women who had undergone or were undergoing adjuvant chemotherapy after breast cancer surgery recruited from a convenience sample from a university hospital in Korea were included in the study. The attentional function index was used to measure perceived cognitive function while the linear analogue self-assessment scale was used to measure mood disturbance. Hierarchical multiple regression analyses were done to determine possible predictors of perceived cognitive function in patients with breast cancer. Perceived cognitive function and mood disturbance had a mean score of 66.22 (SD= 13.43) and 159.78 (SD = 81.40), respectively. Mood disturbance was a statistically significant predictor of cognitive function in patients with breast cancer. Breast cancer patients with mood disturbance may experience decrements in perceived cognitive function. Nurses should be aware of mood changes and its influence on perceived cognitive function in breast cancer patients.

Stress Management and Resilience Training Among Department of Medicine Faculty: A Pilot Randomized Clinical Trial

Physician distress is common and related to numerous factors involving physicians' personal and professional lives. The present study was designed to assess the effect of a Stress Management and Resiliency Training (SMART) program for increasing resiliency and quality of life, and decreasing stress and anxiety among Department of Medicine (DOM) physicians at a tertiary care medical center. Forty DOM physicians were randomized in a wait-list controlled clinical trial to either the SMART intervention or a wait-list control group for 8 weeks. The intervention involved a single 90 min one-on-one training in the SMART program. Primary outcome measures assessed at baseline and week 8 included the Connor Davidson Resilience Scale (CDRS), Perceived Stress Scale (PSS), Smith Anxiety Scale (SAS) and Linear Analog Self Assessment Scale (LASA). Thirty-two physicians completed the study. A statistically significant improvement in resiliency, perceived stress, anxiety, and overall quality of life at 8 weeks was observed in the study arm compared to the wait-list control arm: CDRS: mean ± SD change from baseline +9.8 ± 9.6 vs. -0.8 ± 8.2, t(30) = 3.18, p = 0.003; PSS: -5.4 ± 8.1 vs. +2.2 ± 6.1, t(30) = -2.76, p = 0.010; SAS: -11.8 ± 12.3 vs.+ 2.9 ± 8.9, t(30) = -3.62, p = 0.001; and LASA: +0.4 ± 1.4 vs. -0.6 ± 1.0, t(30) = 2.29, p = 0.029. A brief training to enhance resilience and decrease stress among physicians using the SMART program was feasible. Further, the intervention provided statistically significant improvement in resilience, stress, anxiety, and overall quality of life. In the future, larger clinical trials with longer follow-up and possibly wider dissemination of this intervention are warranted.

Lack of association between resident doctors' well-being and medical knowledge

Resident doctors' (residents) well-being impacts on the medical care they provide. Despite the high prevalence of resident doctors' distress, the relationship between their well-being and the specific competencies defined by the Accreditation Council for Graduate Medical Education is poorly understood. We evaluated the association of resident well-being with medical knowledge as assessed on both a standardised test of general medical knowledge and at the end of web-based courses on a series of focused topics. We conducted a repeated cross-sectional study of associations between well-being and medical knowledge scores over time for internal medicine residents from July 2004 to June 2007. Well-being measures included linear analogue self-assessment (LASA) scales measuring quality of life (including overall quality of life, mental, physical and emotional well-being, and fatigue), the Medical Outcome Study Eight-Item Short Form Health Survey (SF-8) assessment of mental and physical well-being, the Maslach Burnout Inventory and the PRIME-MD two-item depression screen. We also measured empathy using the perspective taking and empathic concern subscales of the Interpersonal Reactivity Index. Medical knowledge measures included scores on web-based learning module post-tests and scores on the national Internal Medicine In-Training Examination (IM-ITE). As data for each association were available for at least 126 residents, this study was powered to detect a small-to-moderate effect size of 0.3 standard deviations. No statistically significant associations were observed between well-being and either web-based learning module post-test score or IM-ITE score. Parameter estimates of the association of well-being variables with knowledge scores were uniformly small. For all well-being metrics, meaningful differences were associated with knowledge score difference estimates of < 1 percentage point. Resident well-being appears to have limited association with competence in medical knowledge as assessed following web-based courses on specific topics or using standardised general medical examinations.

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.

Ordinal Regression Models for Continuous Scales

Ordinal regression analysis is a convenient tool for analyzing ordinal response variables in the presence of covariates. In this paper we extend this methodology to the case of continuous self-rating scales such as the Visual Analog Scale (VAS) used in pain assessment, or the Linear Analog Self-Assessment (LASA) scales in quality of life studies. These scales measure subjects' perception of an intangible quantity, and cannot be handled as ratio variables because of their inherent nonlinearity. We express the likelihood in terms of a function connecting the scale with an underlying continuous latent variable and approximate this function either parametrically or non-parametrically. Then a general semi-parametric regression framework for continuous scales is developed. Two data sets have been analyzed to compare our method to the standard discrete ordinal regression model, and the parametric to the non-parametric versions of the model. The first data set uses VAS data from a study on the efficacy of low-level laser therapy in the treatment of chronic neck pain; the second comes from a study on chemotherapy treatments in advanced breast cancer and looks at the impact of different drugs on patients' quality of life. The continuous formulation of the ordinal regression model has the advantage of no loss of precision due to categorization of the scores and no arbitrary choice of the number and boundaries of categories. The semi-parametric form of the model makes it a flexible method for analysis of continuous ordinal scales.

Outcomes of first-line chemotherapy for advanced breast cancer in women with good versus poor quality of life at baseline

1036 Background: Health-related quality of life (QL) is an established predictor of outcome in advanced breast cancer. The benefits and harms of chemotherapy in women with poor QL are unclear. Methods: We used data from 378 women receiving classical CMF in the control arms of 3 randomized trials. QL was rated at baseline by patients with linear analogue self-assessment scales (LASA) for physical well-being (PWB), mood, appetite, pain, nausea/vomiting, and overall QL; and by physicians with Spitzer's Quality-Of-Life Index (QL-I). Patients were divided into 3 groups according to their baseline QL scores: good (LASA 0–25, QL-I 5–7), intermediate (LASA 26–65, QL-I 8–10) or poor (LASA 66–100, QL-I 11–15). The main outcomes were overall survival (OS), progression-free survival (PFS), objective tumor response (OTR = CR or PR), weight loss, and grade 3 or 4 adverse events (AE). Results: All aspects of QL, except nausea/vomiting, were significant univariable predictors of OS and PFS. PWB, mood, appetite and QL-I were independently significant predictors of OS in a multivariable model with biomedical factors. Only patient's self-rated poor QL had lower rates of OTR, and higher rates of nonhematological AE than those with good QL (see Table), but rates of hematological AE were similar. Weight loss occurred more frequently in those with poor appetite (OR 5.8, p=0.05) or poor PWB (OR 4.9, p=0.05). Conclusions: Less than 25% of women with poor baseline QL responded to first line CMF but over 25% had severe non-hematological toxicity. Baseline QL predicts these outcomes beyond biomedical factors. [Table: see text] No significant financial relationships to disclose.

Use of the Prostate Cancer–specific Quality of Life Instrument (PROSQOLI) in clinical practice

e20569 Background: Improvement of quality of life (QOL) is a major therapeutic goal for men with advanced prostate cancer (APC). The PROSQOLI consists of a series of 9 linear analog self-assessment (LASA) scales that evaluate pain, fatigue, appetite, constipation and other symptoms, and overall well-being; it was designed and validated for use in patients with APC. Here we evaluate the use of a computer-based version of the PROSQOLI in routine clinical practice for its ability to stimulate recognition of symptoms and for its impact on clinical decision-making. Methods: Consenting patients with APC completed a touch screen version of the PROSQOLI before seeing the doctor at visits to the outpatient clinic. In phase I of the study physicians did not have access to this information; in phase II physicians were provided with results of the PROSQOLI and its changes from previous visits. Physicians’ recognition of symptoms, and changes in management were extracted from transcribed clinical notes. Results: 36 men were recruited, and data collected from 120 clinic visits (85 phase I, 35 phase II). Normalized symptom scores (0=none; 100 =very severe) were highest for fatigue (median = 42), followed by urinary problems (27) and mood (27) with no differences between phases. Median normalized pain scores were 25 in phase I and 11 in phase II (p=0.03). Changes in management occurred in 41% of phase I, and 43% of phase II visits (NS). Comparison of patient-assessed and physician-described symptoms was limited by lack of documentation in transcribed notes: mention of PROSQOLI symptoms ranged from 75% of visits for pain to 2/120 visits for mood. Presence or absence of fatigue and urinary symptoms were described at 53% and 40% of visits respectively. Rates of documentation did not differ between study phases. Conclusions: No impact on patient care could be demonstrated as a result of computer-based self-assessment of changes in symptoms and QOL. Prostate cancer-specific symptoms were poorly documented in clinical notes; improved recording of symptoms might be facilitated by the use of a tool such as the electronic touch-screen PROSQOLI. No significant financial relationships to disclose.

Aerobic Exercise Decreases Depression and Anxiety in Breast Cancer Survivors

Breast cancer has a profound impact on women's health. There are many psychosocial effects including depression, anxiety, anger, and confusion. Depression and anxiety are common symptoms of survivors living with cancer and can adversely affect wellbeing and rehabilitation. PURPOSE: The purpose of this study was to test the effect of low to moderate intensity aerobic exercise on depression and anxiety in women who have completed treatment for breast cancer. METHODS: Twenty-two survivors of breast cancer (43–79 years of age, at least one month post-treatment) were randomly assigned to either an exercise group (n=12) or a control group (n= 10). The exercise group participated in a low to moderate intensity (30–50% heart rate reserve) aerobic exercise program three times a week for ten weeks. The control group did not participate in the exercise program. The Linear Analogue Self-Assessment (LASA) Scale was administered to subjects prior to the onset and at the conclusion of the ten weeks of exercise. This scale provides a measure of emotional distress and specifically includes measures of anxiety, confusion, depression, energy, and anger. RESULTS: Statistical analysis revealed a significant improvement depression (p = .005), anxiety (p = .03), confusion (p = .04), and anger (p = .02) in the exercise group compared to the control group (p = .001). There was no statistical difference between the groups on the measure of energy (p = .19). More specifically, depression decreased in the exercise group (23.0 + 5.4 to 2.5 + 1.1) and increased in the control group (7.6 + 2.5) to 13.2 + 6.1), anxiety decreased in the exercise group (31.5 + 7.5 to 4.25 + 1.6) and stayed the same in the control group (15.9 + 6.8), confusion decreased in the exercise group (21.0 + 5.1 to 6.3 + 4.0) and increased in the control group (6.7 + 2.0 to 10.7+ 6.2), anger decreased in the exercise group (14.3+6.2 to 4.0 + 2.5) and increased in the control group (4.6 + 1.4 to 13.8 + 7.3). CONCLUSIONS: This aerobic exercise program was effective in reducing depression, anxiety, confusion, and anger in this group of breast cancer survivors. Guidelines for an exercise intervention are already in place for chronic diseases such as diabetes and cardiovascular disease but no guidelines are in place for cancer survivors. Low to moderate intensity exercise is a safe, beneficial, efficient, and cost-effective tool for improving depression and anxiety in breast cancer survivors.

Effects of a high-fat diet on body composition in cancer patients receiving chemotherapy: a randomized controlled study

Patients with cancer are characterized by a profound impairment of glucose utilization, with lipids being the preferred metabolic fuel. In contrast, the energy needs of malignant tumors are almost entirely met by glucose. We therefore studied the effects of a high-fat diet, particularly on body composition. Twenty-three moderately malnourished patients with gastrointestinal carcinomas were randomized to receive either a conventional diet supplying 35 nonprotein kcal and 1.1 g of protein/kg per day (group A, n = 11) or a fat-enriched artificial liquid diet (20 nonprotein kcal/kg per day) plus normal meals (group B, n = 12) for a period of eight weeks, i.e., from the first to the third chemotherapy cycle. The fat content of the artificial diet was 66% of the nonprotein calories. The day before the nutritional interventions, and again after four and eight weeks, body compartments were determined using bioelectrical impedance analysis, lymphocyte subpopulations were quantified using flow cytometry, and some aspects of the quality of life were rated using four linear analog self-assessment (LASA) scales. The statistical calculations were done as an exploratory data analysis. The consumption of non-protein calories did not differ significantly between the two patient groups. An average weight gain in group B contrasted with an average weight loss in group A after four (P < 0.01) and eight weeks (P < 0.05). Fat-free mass showed an intergroup difference in favor of group B after eight weeks (P < 0.05). Body cell mass was maintained throughout the study in group B, but declined significantly up to weeks 4 and 8 in group A (intergroup difference: P < 0.05 and 0.01, respectively). A decrease in the total lymphocyte count by 559 cells/mul occurred with the fat-enriched diet (P < 0.05). Several aspects of the quality of life were rated to be better in group B than in group A, although not all differences reached statistical significance. In patients with cancer, a high-fat diet may possibly support the maintenance of both body weight and body cell mass. However, monitoring the lymphocyte count is advisable.