Functional Quality Of Life Scores Research Articles

Longitudinal Quality-of-Life Outcomes of Skull Base Chondrosarcoma Patients following Surgical Resection

Abstract Objective Owing to the rarity of skull base chondrosarcomas (CS), much of its natural history and long-term impact on patient quality of life (QoL) are not well studied. This novel study demonstrates QoL among CS patients following radical treatment constituting surgery and postoperative radiotherapy over 2 decades. Study Design Retrospective review and prospective data collection to obtain patient demographic, tumor characteristics, clinical symptoms, and patient-reported QoL outcomes using the 36-Item Short Form Health Survey (SF-36). Setting/Participants Patients diagnosed with CS who underwent radical intent surgical resection by the senior author and adjuvant early postoperative proton beam therapy. Results Twenty-eight skull base CS patients were identified, with 19 patients completing full treatment course. Mean long-term follow-up was 148.9 months. Diplopia symptom resolution was high. No significant deterioration in SF-36 Physical Health Component (PHC) and Mental Health Component (MHC) scores was observed at postoperative and long-term follow-up. General health was stable initially but deteriorated in long term (Δ −18.88, minimal clinically important difference [MCID]: 9.86, p = 0.04). Compared with age-matched Canadian control patients, CS patients reported similar PHC scores at baseline and follow-up. CS patients reported lower MHC scores (45.8 vs. 50.9, p = 0.13) preoperatively, which persisted at follow-up decreasing by 1.9 (43.9 vs. 53.7, p = 0.03); this difference, however, did not reach MCID threshold of Δ 5.9. Conclusion We present the longest follow-up data on CS demonstrating stable long-term QoL with aggressive surgery. Tumor control was high and preoperative tumor size did not affect long-term QoL. Preoperative QoL was lower among CS compared with Canadian normative data. Postoperatively, only the decline in physical functioning QoL scores exceeded MCID. At long-term follow-up, the decline in physical functioning, social functioning, and general health exceeded MCID. Overall, QoL among CS patients remained lower at long-term follow-up despite absence of tumor progression and resolution of symptoms.

Quality of life and associated factors among patients with cancer receiving chemotherapy at Dessie Comprehensive Specialized Hospital, North-East Ethiopia: a cross-sectional study.

Cancer is a major public health problem around the world. Cancer by itself and its treatment modalities affect the quality of life (QoL) of patients with it. However, there were a paucity of studies about the QoL of patients receiving chemotherapeutic treatment in Ethiopia. This study was aimed at addressing such a gap. Accordingly, we investigated QoL and associated factors among cancer patients receiving chemotherapy at Dessie Comprehensive Specialized Hospital (DCSH), North East Ethiopia, in 2023. We employed a cross-sectional study from April 1 to May 30, 2023. The data was collected using the European Organization for Research and Treatment of Cancer Core QoL Questionnaire, version 3.0 (EORTC QLQ-C30). The data was entered and cleaned using EpiData version 4.6 and exported to Statistical Package for Social Sciences (SPSS) version 27 for analysis. The association between the dependent and independent variables was determined using Odds Ratios (ORs) at a p value < 0.05 with a 95% CI. Data was collected from 394 patients. Their mean summary QoL score was 36.3 ± 9.0. About 39.3% demonstrated a good QoL summary score, whereas 60.7% were impacted by symptoms. A good functional QoL score was observed in 42.6% of the participants. About 54.8% and 31.7% reported good overall health status and good overall QoL, respectively. The most impacted functional domain was social functioning, affecting 64.5% of participants. The most common symptom was diarrhea, affecting 65.5% of the participants. Secondary school education level (Adjusted Odds Ratio-AOR = 3.16, 95% CI: 1.14-8.81), diploma and above education level (AOR = 4.90, 95% CI: 1.29-18.62), and urban residency (AOR = 1.74, 95% CI: 1.07-2.82) had a significant positive association with QoL, while being a civil servant (AOR = 0.13, 95% CI: 0.04-0.49), having stage III cancer (AOR = 0.14, 95% CI: 0.05-0.39), and stage IV cancer (AOR = 0.16, 95% 0.06-0.44) had a significant negative association with it. The QoL for cancer patients undergoing chemotherapy was significantly low and associated with their level of education, occupational status, area of residence, and stage of cancer. Incorporating psychosocial support is thus crucial in their treatment plans.

Strabismus surgery in poor binocular potential

Background: Previous studies prove improvement in quality of life (QOL) after strabismus surgery. Aims: The aim is to study the change in QOL and binocular functions after strabismus surgery in patients with poor binocular potential. Setting and Design: A tertiary care center-based prospective study was done over a period of 1 year to evaluate the change in scores of adult strabismus-20 (AS-20) questionnaire after successful strabismus surgery. Materials and Methods: All patients above 10 years attending the orthoptic clinic with horizontal squint were evaluated for their probability of gaining binocularity on binocular potential score and were graded into four categories. Those with poor grade of binocular potential, having a poor chance of regaining binocularity after surgery, were included in the study. They underwent surgical ocular alignment and answered the AS-20 questionnaire for QOL preoperatively and 3 months postoperatively. Statistical Analysis Used: Comparison of preoperative scores was done using unpaired t-test. The mean pre- and post-operative scores were compared using paired t-test. Two-sided significance level with P &lt; 0.05 was considered statistically significant. Results: Out of 53 patients, surgical outcomes of 5 were outside successful limits. Of the remaining, 18 (37.5%) were esotropic and 30 (62.5%) had exotropia. Improvement in the mean psychosocial and functional scores was 13.1 ± 6.0 and 7.6 ± 6.3, respectively. Mean overall, psychosocial, and functional QOL scores were significantly higher after successful surgical ocular alignment. Conclusion: Statistically significant improvement occurs in psychosocial and functional QOL of strabismus patients (on AS-20) with poor binocular potential undergoing successful strabismus surgery. Thus, ocular alignment in such cases can be a feasible option for improving QOL rather than mere cosmetic comeback.

Evaluating the Quality of Life and Transition of Adolescents and Young Adults with Asthma in an Inner City

Purpose This study examines the correlation of the Mini Pediatric Asthma Quality of Life Questionnaire (miniPAQLQ) with the Got Transitions Readiness Assessment Survey (GTRAS) of inner-city adolescents and young adults with asthma in Newark, New Jersey. Methods One hundred six patients with asthma, aged 12-21 years old, were assessed at University Hospital in Newark, NJ while receiving typical care. In this cross-sectional study, patients were assessed using the miniPAQLQ and GTRAS tools. General demographics were captured. MiniPAQLQ sections on activity, symptom, and emotional function, were compared to the GTRAS questions on perceived transition readiness and ability to complete healthcare tasks. Results Fifty-three percent of the patients were female, 57% were African American, 37% were Latino/a, and 97% had insurance. The overall median quality of life (QOL) score was 6. Specific activity, symptom and emotional function QOL scores did not correlate with overall perceived transition readiness. However, QOL scores >5 did correlate with patients’ abilities to complete specific health-related tasks of transition, especially when comparing emotional function and “knowing” their health. Conclusions Our results demonstrate that the emotional function of adolescents and young adults with asthma is significantly linked to their ability to complete healthcare tasks independently, indicating that a psychological-based approach to transition may be necessary. Low emotional QOL scores may help identify patients at risk of poor transition who would benefit from additional intervention. Further research is needed to assess quality of life and its effects on development of these patients. Keywords: asthma, adolescent, young adult, transition, independence, quality of life

Development and psychometric properties of the Thai Graves\u2019 ophthalmopathy quality of life (GO-QOL) questionnaire

PurposeTo develop and assess the psychometric properties of the Thai version of the Graves’ Ophthalmopathy Quality of Life (GO-QOL) questionnaire.BackgroundGraves’ ophthalmopathy (GO) is a chronic condition that causes negative self-image and impaired visual function. These conditions impact quality of life (QOL) but are rarely documented. Graves’ Ophthalmopathy Quality of Life Questionnaire (GO-QOL) has good validity, reliability and responsiveness. In this study we developed a Thai GO-QOL questionnaire by translating the questionnaire from English to the Thai language and evaluated its reliability and validity.Patients and methodsForward and backward translations were performed independently by four translators with extensive experience in both English and Thai. Seventy patients at the thyroid clinic responded to the Thai translated version upon their first visit and again 2–3 weeks afterwards. Validity was assessed by the content validity index (CVI) and correlation with relevant clinical parameters. Reliability was evaluated by Cronbach’s alpha, the intraclass correlation coefficient, and the Bland-Altman plot.ResultsThe Thai GO-QOL version showed high CVI (0.97) and a moderate negative correlation of the functional QOL score with disease severity (r = − 0.49), the clinical activity score (r = − 0.31), and exposure parameter (r = − 0.32). It showed good reliability with a high intraclass correlation coefficient (0.92) and high Cronbach’ s coefficient (0.86).ConclusionThe Thai GO-QOL has good validity and reliability. It can be used to evaluate the quality of life of Graves’ ophthalmopathy patients as a consequence of their disease in thyroid treatment programs.

Radical Prostatectomy in Metastatic Castration-resistant Prostate Cancer: Feasibility, Safety, and Quality of Life Outcomes

Ongoing prospective studies are evaluating treatment of the primary tumor in men with de novo metastatic prostate cancer (PCa). One potential benefit is prevention of morbidity from local progression. Thus, local therapy may be best applied selectively to men with local progression once resistance to first-line therapies has occurred. Here, we gather support for the hypothesis that radical prostatectomy (RP) is safe and preserves quality of life (QOL) when applied in men with metastatic castration-resistant PCa (mCRPC). We analyzed 14 patients who underwent RP in the setting of mCRPC from 2008 to 2016. Median time from mCRPC to RP was 5.1 mo (interquartile range [IQR] 1.4–12.0). Median preoperative and <3 mo postoperative Expanded Prostate Cancer Index Composite urinary function QOL scores were 84 (IQR 70–95) and 78 (IQR 62–81), respectively. There were one Clavien Grade III, three Grade II, and one Grade I complications postoperatively. In these patients with mCRPC, RP was feasible with limited minor complications. Patient summaryWe report on a select group of men with metastatic castration-resistant prostate cancer who had prostatectomy. Prostatectomy is highly investigational in this setting and should not be used outside of a clinical trial other than for symptom relief.

Radical prostatectomy in metastatic castration-resistant prostate cancer: Feasibility, safety, and quality of life outcomes.

244 Background: Ongoing studies are evaluating the role of definitive treatment of the primary tumor in men with de novo metastatic prostate cancer. If proven beneficial, the optimal timing of the intervention will need to be considered. Little is known regarding the safety and quality of life outcomes of RP in metastatic castration resistant PCa (mCRPC). Methods: 14 pts undergoing RP on clinical trials and in the setting of mCRPC from 2008-2016 were analyzed. Intra-op and post-op complications were assigned Clavien-Dindo grade. Post-op expanded prostate cancer index composite (EPIC) urinary domains quality of life (QOL) outcomes were reviewed. Results: Patient characteristics were summarized (Table). 5 (36%) pts received platinum based chemo prior to RP. 4 pts had a decrease in PSA post RP (range: 0.2-57.3 ng/ml); 7 pts had an increase in PSA post RP (range: 0.1-24.5 ng/ml); and 3 pts’ PSA was unchanged. Positive surgical margin rate was 57%. 3 of 6 cN0 pts were pN1. 1 of 8 cN1 pts were pN0. 12/14 pts underwent extended lymphadenectomy with a median 3 (IQR 0-4) positive LNs out of 17 (IQR 11-25) LNs removed. Median op time was 239 min (IQR 186-304). Median EBL was 200cc (IQR 150-225). 8 pts had bilateral non-nerve sparing. Median pre-op and &lt;3month post-op EPIC urinary function QOL scores were 84 (IQR 70-95) and 78 (IQR 62-810) respectively. 30-day mortality was 0% and 12/14 pts were alive at 1 year post RP. There were no intra-op complications. There was one Clavien Grade III complication (pelvic abscess), with remaining 5 complications either Grade I or II. Conclusions: In this select cohort of pts with mCRPC, RP was feasible with limited complications. Differences in pre-op and post-op urinary QOL scores were not clinically significant. Given the retrospective nature of the review and the heterogeneity of this heavily pre-treated population, clinical benefit cannot be ascribed to the intervention. Thus, we caution against RP in mCRPC outside of well-designed clinical trials other than for palliation. [Table: see text]

Therapeutic Effects of Nurse Telephone Follow-up for Lung Cancer Patients in Turkey.

Patients with lung cancer can encounter many difficulties as they adjust to the side effects of chemotherapy treatments. The aim of this study is to determine the therapeutic effects of nurse telephone follow-up for lung cancer patients. In this quasi-experimental study, the sample consisted of 60 patients with lung cancer assigned to an intervention group (n = 30) and a control group (n = 30). The control group participants were sequentially enrolled first and then the intervention group participants were enrolled. The data were collected using the Patient Information Form, Eastern Cooperative Oncology Group Performance Status, the Edmonton Symptom Assessment Scale, and the Functional Living Index-Cancer. The Nursing Care Guide was created by the nurse researchers' team and given to both the intervention and control groups. Telephone follow-up calls were conducted with intervention patients within the first week after their chemotherapy session. The Kolmogorov-Smirnov, Pearson χ, Fisher exact, Mann-Whitney U, and Friedman test and descriptive statistics were used to evaluate the data. Patients in the intervention group demonstrated significantly better adjustment to the symptoms secondary to chemotherapy and higher social functioning quality of life scores compared with reported scores in the control group. Nurse telephone follow-up can reduce chemotherapy-related symptoms for lung cancer patients and improve participants' social functioning. Nurse telephone follow-up is an acceptable and feasible form of patient contact and is a convenient and efficient way to offer patients the support and continuity of care they need.

Related quality of life questionnaire specific to dysthyroid ophthalmopathy evaluated in a population of patients with Graves' disease.

The aim of this study was to measure quality of life (QOL) impairment in individuals currently suffering from Graves' ophthalmopathy (GO) and to determine the correlation of GO-specific QOL scores with disease severity and activity. Seventy three GO-specific QOL surveys were prospectively analysed and compared with GO status. The GO-specific QOL survey was translated into Spanish and applied to Argentine patients with Graves' disease (GD). Results were compared with presence or absence of GO, Clinical Activity Score (CAS), severity score, age, gender and thyroid function. Fifty-six patients answered the survey and underwent complete ophthalmic evaluation, 15 did not have GO and were considered to be a control group. Appearance QOL score for patients with GO (53 ± 31.4) was lower than the control group (88.3 ± 17) (p < 0,000), no difference was observed in functional QOL score. There was a negative correlation between GO severity and both functional (r = -0.575; p < 0.000) and appearance QOL (r = -0.577; p < 0.000). Functional QOL differed between patients with active GO vs control group (p = 0.043). Patients with active and inactive GO had lower appearance QOL scores than control group (p < 0.000, p < 0.001 respectively). GO has significant impact on the life of these Argentine patients. QOL was worse in GO patients than in control group, functional QOL was mostly affected by the activity and appearance QOL was mainly altered by the effects of the disease. Patients with more severe GO had lower scores on both QOL scales.

Rehabilitation strategies following oesophageal cancer: The ReStOre trial—A feasibility study.

176 Background: Esophageal cancer is an examplar model of complex cancer care with defined quality of life (QOL) consequences. While prognosis for this aggressive disease is poor, survival is slowly improving leading to the emergence of a unique group of cancer survivors with complex rehabilitation needs. The ReStOre trial will implement a multi-disciplinary programme to improve functional performance and QOL for esophageal cancer survivors. This pilot work examines the feasibility of the proposed intervention. Methods: This study was a single-arm feasibility study. Patients who had completed curative treatment for esophageal cancer including esophagectomy and who had node-negative post-surgical pathology received a letter of invitation to participate. The programme consisted of 12 weeks supervised and home-based exercise, dietetic counselling and education sessions from the multi-disciplinary team. Feasibility outcomes included recruitment rates, adherence, adverse events and retention. Other outcomes, including cardiopulmonary fitness (maximal cardiopulmonary exercise test and six minute walk test (6MWT)), QOL (EORTC questionnaire) and body composition (bioimpedence analysis), were assessed pre- and post-intervention. Results: Twelve participants (mean (standard deviation (SD) age 61.4 (7.29) years, 8 male) consented to participate, representing a recruitment rate of 55%. Mean class attendance was 82% and mean adherence to the home exercise programme was 118%. No adverse events occurred and all participants completed programme. Aerobic fitness improved by 3.71(2.7) ml/kg/min (19.0 ml/kg/min pre-intervention, 22.7 ml/kg/min post-intervention, p &lt; 0.001). 6MWT distance improved by 56.3 (35.3)m (p &lt; 0.001). Global and functional QOL scores increased while symptom scores decreased. Body composition remained stable. Conclusions: The ReStOre trial demonstrated high feasibility and acceptability in this complex cohort. Improvements in functional performance and QOL were evident without compromise to body composition. While current results are limited due to the selected population and single-arm design they will guide the design of the forthcoming larger randomised controlled trial.

The Health Initiative Program for Kids (HIP Kids): effects of a 1-year multidisciplinary lifestyle intervention on adiposity and quality of life in obese children and adolescents--a longitudinal pilot intervention study.

BackgroundThough recent data suggest that multidisciplinary outpatient interventions can have a positive effect on childhood obesity, it is still unclear which program components are most beneficial and how they affect quality of life (QoL). The aim of this study was to determine if a 1-year multidisciplinary, family-centered outpatient intervention based on social cognitive theory would be effective in (i) preventing further increases in BMI and BMI z-score, and (ii) improving QoL in obese children and adolescents.MethodsObese children and adolescents 8–17 years of age and their families participated in this 1-year longitudinal pilot intervention study. The intervention consisted of fifteen 90-minute educational sessions led by a dietitian, exercise specialist, and social worker. Anthropometric measures, body composition, and QoL (Pediatric Quality of Life Inventory 4.0), were assessed at baseline, 3 months, and 12 months. Laboratory values were measured at baseline and 12 months. The primary outcome measures were change in BMI and BMI z-score, secondary outcome measures included change in QoL and body composition. A paired sample t-test was used to assess within-group differences and 95% confidence intervals were reported for the mean differences.Results42 obese children and adolescents (21 girls) completed the 1-year intervention (mean age 12.8 ± 3.14 years). Mean baseline BMI was 31.96 ± 5.94 kg/m2 and BMI z-score was +2.19 ± 0.34. Baseline QoL (self-assessments and parental assessments) was impaired: mean baseline scores were 74.5 ± 16.5 and 63.7 ± 19.4 for physical functioning and 69.0 ± 14.9 and 64.0 ± 18.3 for emotional functioning, respectively. At 12 months, BMI z-score had decreased (−0.07 ± 0.11, 95% CI: −0.11 to −0.04). BMI (0.80 ± 1.57 kg/m2, 95% CI 0.31 to 1.29) and fat-free mass (4.02 ± 6.27 kg, 95% CI 1.90 to 6.14) increased, but % body fat and waist circumference did not. Both the parent-reported physical (11.3 ± 19.2, 95% CI 4.7 to 17.9) and emotional (7.7 ± 15.7, 95% CI 2.3 to 13.0) functioning QoL scores and the children's self-reported physical (5.3 ± 17.1, 95% CI 0.5 to 11.1) and emotional (7.9 ± 14.3, 95% CI 3.2 to 12.7) functioning scores significantly improved.ConclusionsFollowing a 1-year intervention, the participants’ BMI z-scores and QoL improved, while other adiposity-related measures of body composition remained unchanged.Trial registrationUMIN Clinical Trials Registry UMIN000015622.Electronic supplementary materialThe online version of this article (doi:10.1186/s12887-014-0296-1) contains supplementary material, which is available to authorized users.

Application on the Newman-care system model for senile hypertension

Objective To observe the effect of the Newman-care system model on senile hypertension.Methods 66 cases of elderly patients with hypertension were randomly divided into control group and observation group (n=33).Newman-care system model was applied on the observation group,the control group received conventional nursing.Blood pressure and quality of life were compared in two groups.Results In the observation group,systolic blood pressure dropped by an average level of 26.70 mmHg,diastolic blood pressure dropped by an average level of 15.10 mmHg,compared with those of the control group,the difference was statistically significant (P ＜ 0.05).The patients overall functional quality of life score was 16.70 points,compared with the control group,the difference was statistically significant (P ＜ 0.05).Conclusion In hypertensive patients,the implementation of the Newman-care system model can control patients' blood pressure effectively and improve their quality of life. Key words: Newman-care system model; Hypertension; Nursing

Abstract T P286: Comparison of Neuro-QOL Physical Function and modified Rankin Scale in Stroke

Introduction: The modified Rankin scale (mRS) is a reliable objective measure of disability and is widely applied in clinical trials. Health-related quality of life (QOL) measurements using Neuro-QOL provide validated measures of patient-reported outcomes. We compared changes in physical function QOL scores with transitions in mRS scores after ischemic stroke or transient ischemic attack (TIA). Methods: From a single-center prospective cohort study, we identified ischemic stroke and TIA patients admitted between August 2012 and April 2013 who survived to 3-month follow-up and underwent mRS and Neuro-QOL outcomes assessments at 1 and 3 months. The mRS was assessed by structured telephone interviews and Neuro-QOL scores using short forms of upper extremity (UE) and lower extremity (LE) function. We used Pearson's coefficient to compare mRS and Neuro-QOL scores and assessed mean changes in Neuro-QOL T-scores across mRS strata and between 1 and 3 months. Results: Three-hundred twelve patients met study criteria (mean age 65.2 years; initial NIHSS score 4; 77.2% ischemic stroke). Strong correlations were noted between mRS and physical function QOL scores at 3-months: mRS-LE: r = -0.74; mRS-UE: r = -0.74. UE and LE QOL scores were 6.1 and 7.1 points lower, respectively, in those with mRS of 1 compared with 0. Within individual patients, a 1 point decrease (improvement) in mRS was associated with increase in UE and LE QOL by 5.6 and 3.3 points while a 1 point increase (worsening) in mRS was associated with a decrease in UE and LE QOL by 4.0 and 7.5 points, respectively. By mRS, 7.5% of patients had worsening by at least 1 point between 1 and 3 months while the proportion with at least 1 standard deviation (10 points) decrease in UE or LE QOL scores was 12.1% and 14.4%, respectively. Conclusions: The mRS correlates well with patient-reported scores of physical function using Neuro-QOL. However, Neuro-QOL offers a complementary tool for assessment of neurological function and may help identify finer grades of functional change over time. Using a continuous measurement of function from the patient perspective may also be more valuable to patients and improve statistical power in clinical trials.

Quality of Life in Women with Localised Breast Cancer or Malignant Melanoma 2 Years After Initial Treatment: a Comparison

Two thirds of female breast cancer patients and more than 80 % of malignant melanoma patients are diagnosed with localised disease and good prognosis with a 5-year relative survival of more than 90 % in Germany. This study was conducted to present quality of life (QoL) data from a German population-based cohort of female breast cancer and melanoma patients without recurrence for approximately 2 years after initial diagnosis. In 2003-2004, patients with localised breast cancer and melanoma were recruited from the Munich Cancer Registry (Upper Bavaria, Germany) to answer QoL questionnaires. Differences between breast cancer and melanoma patients were investigated with regard to age and aspects of communication with their medical caregivers. One thousand three hundred and four breast cancer and 348 melanoma patients were included. Breast cancer patients were about 7 years older and had significantly lower QoL and higher symptom scores than melanoma patients. Communication needs were generally similar in both groups; however, breast cancer patients experienced more empathy from their medical caregivers. In breast cancer patients, communication was an independent factor for all QoL functioning scores. Even when faced with a similarly good prognosis, breast cancer patients have a worse QoL than melanoma patients 2 years after diagnosis. An explanation may be more distinctive surgery and systemic therapy, older patients with comorbidities and misunderstood risk communication in breast cancer patients that may stoke anxiety and fears. Further reasons could be unceasing public discussion about breast cancer and its instrumentalisation for political purposes.

Phase 3b UPFRONT Study: Interim Results From a Community Practice-Based Prospective Randomized Trial Evaluating Three Bortezomib-Based Regimens in Elderly, Newly Diagnosed Multiple Myeloma Patients.

Abstract 129In this US community-based, randomized, open-label, multicenter phase 3b study, we compare the safety and efficacy of three highly active bortezomib (Velcade®, Vc)-based regimens for multiple myeloma (MM), Vc–thalidomide–dexamethasone (VcTD), Vc–dexamethasone (VcD), and Vc–melphalan–prednisone (VcMP), in previously untreated MM patients (pts) ineligible for high-dose therapy and autologous stem cell transplantation. Use of these regimens is supported by data from phase 3 studies; only VcMP has been investigated specifically in elderly pts. Here we present data from a pre-specified interim analysis (IA) of 210 pts performed after the first 70 pts in each arm had the opportunity to complete four cycles of therapy. Pts with symptomatic, measurable MM were randomized (1:1:1) to receive 49 weeks of therapy: 24 weeks (eight 21-day cycles) of induction with VcD (Vc 1.3 mg/m2, days 1, 4, 8, 11; D 20 mg, days 1, 2, 4, 5, 8, 9, 11, 12 [Cycles 1–4)], days 1, 2, 4, 5 [Cycles 5–8]), VcTD (Vc 1.3 mg/m2, days 1, 4, 8, 11; T 100 mg/d, d1-21; D 20 mg, days 1, 2, 4, 5, 8, 9, 11, 12 [Cycles 1–4), days 1, 2, 4, 5 [Cycles 5–8]) or VcMP (Vc 1.3 mg/m2, days 1, 4, 8, 11; M 9 mg/m2 and P 60 mg/m2, day 1–4, every other cycle), followed by 25 weeks (five 35-day cycles) of maintenance with Vc alone (1.6 mg/m2, days 1, 8, 15, 22). Prophylactic aspirin, full dose warfarin, or low molecular weight heparin was administered to the VcTD arm unless medically contraindicated.The primary endpoint is progression-free survival; secondary endpoints include overall survival, duration of response, time to next therapy, quality of life (QoL) using the EORTC QLQ-C30 questionnaire, safety and tolerability, and efficacy (CR/nCR, VGPR, PR, and ORR). Responses were assessed by investigators using central laboratory data, applying the International Myeloma Working Group uniform criteria. An Independent Data Monitoring Committee (IDMC) assessed safety, tolerability, response rates and QoL data to determine which two of the three arms should continue enrolling pts. Pts in the VcD, VcTD, and VcMP arms had median ages of 74, 73, and 72 years, respectively; 83%, 58%, and 73% had ISS stage ll/lll and 21%, 22% and 32%, respectively, were non-Caucasian. In the VcD, VcTD, and VcMP arms, mean number of treatment cycles (for the first four cycles) and total Vc doses (16 doses for the first four cycles) were similar: 3.8, 3.6, and 3.7 cycles and 14.5, 13 and 13.8 Vc doses, respectively. The VcD arm had the lowest rate of adverse events (AEs) grade ≥3 (58% vs 71% each in the VcTD and VcMP arms, respectively), as well as the lowest rate of discontinuations due to AEs (10% vs 18% and 16% in the VcTD and VcMP arms, respectively). The VcTD arm had the highest rate of serious AEs (50% vs 39% and 36% in the VcD and VcMP arms, respectively), as well as peripheral neuropathy (PN) of any grade (48% vs 29% and 30% in the VcD and VcMP arms, respectively). PN grade ≥3 was 6%, 12% and 13% in the VcD, VcTD, and VcMP arms, respectively. The VcTD arm had higher rates of serious embolism/thrombosis (8% vs 6% and 3%) than in the VcD and VcMP arms, respectively. All three regimens demonstrated substantial activity. The overall response rate was 60%, 70%, and 52% in the VcD, VcTD, and VcMP arms, respectively (complete response (CR)/near CR: 13%, 18% and 15%; ≥very good partial response 15%, 23% and 24%, respectively). QoL functional scores improved in all arms, except for physical, role function and global health status, which worsened in the VcTD arm only. At a preplanned IA, the three Vc-based regimens were evaluated as having similar risk/benefit considerations after four cycles. The regimens were active with well-characterized and predictable toxicities. The study continues to enroll in all three arms as recommended by the IDMC. The UPFRONT trial demonstrates the feasibility of conducting a large, randomized, outpatient, phase 3b trial in community-based oncology centers in the United States. Disclosures:Niesvizky:Celgene: Consultancy, Research Funding, Speakers Bureau; Millennium Pharmaceuticals, Inc.: Consultancy, Research Funding, Speakers Bureau; Proteolix: Consultancy, Research Funding. Flinn:Millennium Pharmaceuticals, Inc.: Membership on an entity's Board of Directors or advisory committees, Research Funding. Rifkin:Millennium Pharmaceuticals, Inc: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Amgen: Speakers Bureau; Cephalon: Speakers Bureau. Gabrail:Millennium Pharmaceuticals, Inc: Research Funding. Phooshkooru:Millennium Pharmaceuticals, Inc: Consultancy, Honoraria. Charu:Millennium Pharmaceuticals, Inc: Consultancy, Honoraria, Research Funding. Corzo:Millennium Pharmaceuticals, Inc.: Employment. Neuwirth:Millennium Pharmaceuticals, Inc: Employment.

Personality traits and psychosocial stress: quality of life over 2 years following breast cancer diagnosis and psychological impact factors

The aim of this study was to investigate changes in the quality of life (QoL) and body image among breast cancer patients over 2 years and to examine different predictive factors for QoL 2 years after the primary operation. A total of 203 women with a primary diagnosis of breast cancer completed the questionnaires 2 weeks and 6, 12, 18, and 24 months after surgery. Quality of Life Questionnaire (QLQ-C30), Breast Cancer Specific Quality of Life Questionnaire Module (QLQ-BR23), Questionnaire on Stress in Cancer Patients (QSC-R23), Freiburg Personality Inventory (FPI-R), Life Orientation Test (LOT) were used as standardized measures. The overall QoL and most functional and symptom scales improved during the 2-year period. However, cognitive functioning, body image, and the three symptom scales of insomnia, constipation, and diarrhea did not change. Age was only capable of predicting physical functioning, whereas tumor size, axillary surgery, and adjuvant chemotherapy were not predictive of the long-term QoL functional scores. Initial distress was the most potent predictive factor for long-term QoL. Baseline functioning predicted functional QoL scores 2 years later. And higher scores for neuroticism were associated with a poorer QoL. However, optimism was not capable of predicting the QoL 2 years later. Screening measures should be implemented at the time when breast cancer is diagnosed, in order to identify psychologically vulnerable patients and offer them professional psycho-oncological help.

Low-cost outpatient chemotherapy regimen of cisplatin, 5-fluorouracil and leucovorin for advanced head and neck and esophageal carcinomas.

Patients with advanced head and neck (H/N) and esophageal squamous cell carcinoma (SCC) often have a poor performance status and a dire prognosis. Our aim was to evaluate the feasibility, activity and quality of life (QOL) of an outpatient chemotherapy regimen consisting of cisplatin, 5-fluorouracil and leucovorin (CFL). Prospective phase II study conducted at a Brazilian public institution. Fifteen patients with residual, recurrent or metastatic SCC of the H/N or esophagus received bolus infusions of leucovorin 20 mg/m(2)/day and 5-fluorouracil 370 mg/m(2)/day on days 1-4, and 90 minutes of infusion of cisplatin 25 mg/m(2)/day on days 1-3, every 21 to 28 days, depending on hematological recovery. We also evaluated QOL by applying the European Organization for Research and Treatment of Cancer Quality of Life-C30 questionnaire (EORTC QLQ-C30) before each cycle. The overall response rate was 36%, and the mean overall survival and progression-free survival were six and three months, respectively. We observed grade 3 or higher hematological toxicity in seven patients and one patient had grade 3 nausea and vomiting. One patient died because of neutropenic fever. Seven out of the 12 patients who could be evaluated regarding QOL presented an improvement in their overall health status and functional QOL scores over the course of the treatment. CFL is an active outpatient protocol with tolerable toxicity and a favorable QOL impact. Larger studies are warranted, in order to confirm these results.

Quality of life evolution after lung cancer surgery: A prospective study in 100 patients

To evaluate quality of life (QoL) evolution after thoracic surgery for lung cancer with the European Organisation for Research and Treatment of Cancer (EORTC) QoL Questionnaire-C30 and the lung cancer specific module LC13. A prospective QoL registration started in 2002 for all patients undergoing major pulmonary surgery for malignant disease. Between January 2002 and November 2004, 100 patients were included. Questionnaires were administered pre-operatively and 1, 3, 6 and 12 months post-operatively (MPO) with response rates of 100%, 71%, 77%, 83% and 76%, respectively. lobectomy 61%, pneumonectomy 17%, and wedge resection 22%. Approaches: anterolateral thoracotomy 79%, posterolateral thoracotomy 13% and video-assisted thoracic surgery (VATS) 8%. Lobectomy and wedge resection are comparable in QoL evolution. Both resections are characterized by a 1 month temporary decrease in QoL functioning scores and an increase in pain symptoms. Lobectomy patients report an increase in dyspnea in the first month post-operatively, not seen after wedge resection. With exception of thoracic pain after lobectomy, QoL scores approximated baseline values 3MPO indicating good recovery. After pneumonectomy, there is no return to baseline in physical functioning, role functioning, pain, shoulder function and dyspnea in a 12 months follow-up period. Other QoL scores were comparable with baseline values. Pneumonectomy was significantly associated with a less favorable QoL score evolution when compared with lobectomy. Comparing antero- and posterolateral thoracotomy, significant differences in pain and dyspnea were seen in favor of the anterolateral technique. Comparing thoracotomy to VATS, significant differences were seen in physical functioning, QoL and thoracic pain in favor of VATS. The present study documented QoL evolution profiles comparing pre-operative status with deficits and changes at 1, 3, 6 and 12 months after pulmonary surgery. Lung cancer surgery is well tolerated by the majority of patients. Lobectomy patients have a more favorable physical functioning and less thoracic pain, compared to pneumonectomy. Antero- and posterolateral thoracotomy are comparable for QoL evolution. After posterolateral thoracotomy more post-operative pain and dyspnea was seen. Post-operative physical functioning, pain and QoL are in favor of VATS.

Clinical and Quality of Life Comparison of Accelerometer, Piezoelectric Crystal, and Blended Sensors in DDDR‐Paced Patients with Sinus Node Dysfunction in the Mode Selection Trial (MOST)

Permanent pacemakers are capable of increasing heart rate in response to physical activity by a variety of sensors including accelerometers, piezoelectric crystals, or blended sensors. The impact of these different physiologic sensors on cardiovascular events and quality of life is not known. Of 2,010 patients randomized in the Mode Selection Trial, 1,245 patients were selected with the most commonly used pacemakers with these three sensors. Clinical characteristics and quality of life were compared between groups at baseline, 3 months, and then yearly. There were 449 patients with an accelerometer sensor device, 682 with a piezoelectric sensor, and 114 with a blended sensor. The groups were similar in terms of age (mean 74 years), gender, and cardiac risk factors but differences existed in weight, heart rate, mitral regurgitation, revascularization history, and drug therapy. The median ventricular pacing frequency was 80% (25th, 75th percentiles 42, 97). After a median follow-up of 33.1 months, the risk of death, heart failure hospitalization, atrial fibrillation, and the combined endpoint of mortality and stroke was not significantly different between the sensor types, after adjustment for baseline differences. Quality of life analyses demonstrated that patients with blended sensors had significantly worse (P < 0.01) physical function than did patients with the other two sensor systems. Moreover, patients receiving blended sensors had the poorest absolute scores, without reaching statistical significance, on 9 of 13 quality of life measures after adjusting for differences in the groups. We found no significant differences among the three most utilized sensors in clinical endpoints. Those patients who received blended sensors had worse physical function quality of life scores. However, clinical selection of the most sophisticated sensor for the most ill patients cannot be excluded as an explanation of these results.

Dietary Counseling Improves Patient Outcomes: A Prospective, Randomized, Controlled Trial in Colorectal Cancer Patients Undergoing Radiotherapy

To investigate the impact of dietary counseling or nutritional supplements on outcomes in cancer patients: nutritional, morbidity, and quality of life (QoL) during and 3 months after radiotherapy. A total of 111 colorectal cancer outpatients referred for radiotherapy, stratified by staging, were randomly assigned: group 1 (G1; n = 37), dietary counseling (regular foods); group 2 (G2; n = 37), protein supplements; and group 3 (G3; n = 37), ad libitum intake. Nutritional intake (diet history), status (Ottery's Subjective Global Assessment), and QoL (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0) were evaluated at baseline, at the end, and 3 months after radiotherapy. At radiotherapy completion, energy intake increased in G1/G2 (P < or = .04), G1 more than G2 (P = .001), and decreased in G3 (P < .01). Protein intake increased in G1/G2 (P < or = .007), G1 less than G2 (not significant), and decreased in G3 (P < .01). At 3 months, G1 maintained nutritional intake and G2/G3 returned to baseline. After radiotherapy and at 3 months, rates of anorexia, nausea, vomiting, and diarrhea were higher in G3 (P < .05). At radiotherapy completion, in G1 all QoL function scores improved proportionally to adequate intake or nutritional status (P < .05); whereas in G2 only three of six function scores improved proportionally to protein intake (P = .04), and in G3 all scores worsened (P < .05). At 3 months, G1 patients maintained/improved function, symptoms, and single-item scores (P < .02); in G2, only few function and symptom scales improved (P < .05); in G3, QoL remained as poor as after radiotherapy. In G1/G2, respectively, improvement/deterioration of QoL correlated with better or poorer intake or nutritional status (P < .003). During radiotherapy, both interventions positively influenced outcomes; dietary counseling was of similar or higher benefit, whereas even 3 months after RT, it was the only method to sustain a significant impact on patient outcomes.