Purpose Percutaneous biliary drainage (PBD) is used to relieve malignant bile duct obstruction (MBO) when endoscopic drainage is not feasible. Little is known about the effects of PBD on the quality of life (QoL) in patients with MBO. The aim of this study was to evaluate changes in QoL and pruritus after PBD and to explore the variables that impact these changes. Patients and Methods Eligible patients reported their QoL and pruritus before and after PBD using the Functional Assessment of Cancer Therapy – Hepatobiliary instrument (FACT-HS) and the Visual Analog Scale for Pruritus (VASP). Instruments were completed pre-procedure and at one and four weeks following PBD. Results One hundred and nine (60 male/49 female) patients enrolled, 102 (94%) had unresectable disease. PBD was technically successful (hepatic ducts cannulated at the conclusion of procedure) in all patients. There were two procedure-related deaths. All-cause mortality was 10% (N=11) at 4 weeks and 28% (N=31) at 8 weeks post PBD with a median survival of 4.74 months. The mean FACT-HS scores declined significantly (P<.01) over time (101.3, 94.8, 94.7 at baseline, 1 week, 4 weeks, respectively). The VASP scores showed significant improvement at 1 week with continued improvement at 4 weeks (P<.01). Conclusion PBD improves pruritus but not QoL in patients with MBO and advanced malignancy. There is high early mortality in this population.
Background Postmastectomy radiotherapy in patients with four or more positive axillary nodes reduces breast cancer mortality, but its role in patients with one to three involved nodes is controversial. We assessed the effects of postmastectomy radiotherapy on quality of life (QOL) in women with intermediate-risk breast cancer. MethodsSUPREMO is an open-label, international, parallel-group, randomised, controlled trial. Women aged 18 years or older with intermediate-risk breast cancer (defined as pT1-2N1; pT3N0; or pT2N0 if also grade III or with lymphovascular invasion) who had undergone mastectomy and, if node positive, axillary surgery, were randomly assigned (1:1) to receive chest wall radiotherapy (50 Gy in 25 fractions or a radiobiologically equivalent dose of 45 Gy in 20 fractions or 40 Gy in 15 fractions) or no radiotherapy. Randomisation was done with permuted blocks of varying block length, and stratified by centre, without masking of patients or investigators. The primary endpoint is 10-year overall survival. Here, we present 2-year results of QOL (a prespecified secondary endpoint). The QOL substudy, open to all UK patients, consists of questionnaires (European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BR23, Body Image Scale, Hospital Anxiety and Depression Scale [HADS], and EQ-5D-3L) completed before randomisation, and at 1, 2, 5, and 10 years. The prespecified primary outcomes within this QOL substudy were global QOL, fatigue, physical function, chest wall symptoms, shoulder and arm symptoms, body image, and anxiety and depression. Data were analysed by intention to treat, using repeated mixed-effects methods. This trial is registered with the ISRCTN registry, number ISRCTN61145589.Findings Between Aug 4, 2006, and April 29, 2013, 1688 patients were enrolled internationally and randomly assigned to receive chest wall radiotherapy (n=853) or not (n=835). 989 (79%) of 1258 patients from 111 UK centres consented to participate in the QOL substudy (487 in the radiotherapy group and 502 in the no radiotherapy group), of whom 947 (96%) returned the baseline questionnaires and were included in the analysis (radiotherapy, n=471; no radiotherapy, n=476). At up to 2 years, chest wall symptoms were worse in the radiotherapy group than in the no radiotherapy group (mean score 14·1 [SD 15·8] in the radiotherapy group vs 11·6 [14·6] in the no radiotherapy group; effect estimate 2·17, 95% CI 0·40-3·94; p=0·016); however, there was an improvement in both groups between years 1 and 2 (visit effect -1·34, 95% CI -2·36 to -0·31; p=0·010). No differences were seen between treatment groups in arm and shoulder symptoms, body image, fatigue, overall QOL, physical function, or anxiety or depression scores.Interpretation Postmastectomy radiotherapy led to more local (chest wall) symptoms up to 2 years postrandomisation compared with no radiotherapy, but the difference between groups was small. These data will inform shared decision making while we await survival (trial primary endpoint) results.
Background: Children with cancer often experience decreased quality of life (QOL) throughout the illness trajectory. The purpose of this study was to explore the associations of demographic characteristics with QOL in children with advanced cancer. Methods: This secondary analysis was part of a larger randomized clinical trial that evaluated the efficacy of a legacy intervention for children (7–17 years) with relapsed/refractory cancer and their primary parent caregivers. Assessments included child self-reports on the Pediatric Quality of Life Inventory (PedsQL) Cancer Module. Researchers used descriptive and linear regression statistical methods. Results: Children ( n = 128) averaged 10.9 years (SD = 3.0). The majority were female ( n = 68, 53%), white ( n = 107, 84%), had a hematologic malignancy ( n = 67, 52%), with family incomes of $50,000 or less ( n = 81, 63.3%). Statistically significant positive associations of both age and income level with PedsQL scores were observed ( p < .05) but not gender ( p > .05). The strongest correlations for age were with the procedural anxiety ( beta = 0.42), treatment anxiety ( beta = 0.26), and total ( beta = 0.28) scores (all p < .01). In general, there was a positive correlation between family income levels and PedsQL scores ( p < .05). The strongest correlations for income were with nausea ( R = 0.49), appearance ( R = 0.44), pain, and treatment anxiety (both R = 0.42) (all p < .01). Associations adjusted for age remained essentially the same (all p < .01). Discussion: Children with advanced cancer with lower family income and younger age are at high risk for poorer QOL. Oncology nurses should seek to identify families who may benefit from additional resources to promote QOL.
ObjectivePercutaneous tunneled drainage catheter (PTDC) placement is a palliative alternative to serial paracenteses in patients with end-stage cancer and refractory ascites. The impact of PTDC on quality of life (QoL) and long-term outcomes has not been prospectively described. The objective was to evaluate changes in QoL after PTDC.MethodEligible adult patients with end-stage cancer undergoing PTDC placement for refractory ascites completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and McGill Quality of Life instruments before PTDC placement and at 2 to 7 days and 2 to 4 weeks after PTDC. Catheter function, complications, and laboratory values were assessed. Analysis of QoL data was evaluated with a stratified Wilcoxon signed-rank test.ResultFifty patients enrolled. Survey completion ranged from 65% to 100% (median 88%) across timepoints. All patients had a Tenckhoff catheter, with 98% technical success. Median survival after PTDC was 38 days (95% confidence interval = 32, 57 days). European Organization for Research and Treatment of Cancer scores showed improvement in global QoL (p = 0.03) at 1 week postprocedure (PP). Significant symptom improvement was reported for fatigue, nausea/vomiting, pain, dyspnea, insomnia, and appetite at 1 week PP and was sustained at 3 weeks PP for dyspnea (p < 0.01), insomnia (p < 0.01), and appetite loss (p = 0.03). McGill Quality of Life demonstrated overall QoL improvement at 1 (p = 0.03) and 3 weeks (p = 0.04) PP. Decline in sodium and albumin values pre- and post-PTDC slowed significantly (albumin slope –0.43 to –0.26, p = 0.055; sodium slope –2.50 to 1.31, p = 0.04). Creatinine values increased at an accelerated pace post-PTDC (0.040 to 0.21, p < 0.01). Thirty-eight catheter-related complications occurred in 24 of 45 patients (53%).Significance of resultsQoL and symptoms improved after PTDC placement for refractory ascites in patients with end-stage malignancy. Decline in sodium and albumin values slowed postplacement. This study supports the use of a PTDC for palliation of refractory ascites in cancer patients.
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