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The effect of geriatric intervention in frail older patients receiving chemotherapy for colorectal cancer: a randomised trial (GERICO).
Lund, CM, Vistisen, KK, Olsen, AP, Bardal, P, Schultz, M, Dolin, TG, Rønholt, F, Johansen, JS, Nielsen, DL
British journal of cancer. 2021;(12):1949-1958
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Abstract
BACKGROUND Older patients with colorectal cancer (CRC) experience chemotherapy dose reductions or discontinuation. Comprehensive geriatric assessment (CGA) predicts survival and chemotherapy completion in patients with cancer, but the benefit of geriatric interventions remains unexplored. METHODS The GERICO study is a randomised Phase 3 trial including patients ≥70 years receiving adjuvant or first-line palliative chemotherapy for CRC. Vulnerable patients (G8 questionnaire ≤14 points) were randomised 1:1 to CGA-based interventions or standard care, along with guideline-based chemotherapy. The primary outcome was chemotherapy completion without dose reductions or delays. Secondary outcomes were toxicity, survival and quality of life (QoL). RESULTS Of 142 patients, 58% received adjuvant and 42% received first-line palliative chemotherapy. Interventions included medication changes (62%), nutritional therapy (51%) and physiotherapy (39%). More interventional patients completed scheduled chemotherapy compared with controls (45% vs. 28%, P = 0.0366). Severe toxicity occurred in 39% of controls and 28% of interventional patients (P = 0.156). QoL improved in interventional patients compared with controls with the decreased burden of illness (P = 0.048) and improved mobility (P = 0.008). CONCLUSION Geriatric interventions compared with standard care increased the number of older, vulnerable patients with CRC completing adjuvant chemotherapy, and may improve the burden of illness and mobility. TRIAL REGISTRATION ClinicalTrials.gov ID: NCT02748811.
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Use of a Digital Monitoring Platform to Improve Outcomes in Infants With a Single Ventricle.
Vergales, J, Peregoy, L, Zalewski, J, Plummer, ST
World journal for pediatric & congenital heart surgery. 2020;(6):753-759
Abstract
BACKGROUND Despite advances, infants with single ventricle heart disease continue to have high morbidity and mortality in the first year of life. Home monitoring programs (HMPs) have reduced mortality and have grown to use integrative digital platforms. The objective was to evaluate how implementation of a digital HMP platform affects nutritional outcomes in infants undergoing staged single ventricle palliation. METHODS We conducted a retrospective, multicenter, observational study of all infants who required a neonatal operation as part of staged single ventricle palliation between 2013 and 2018. Patients were excluded if less than 35 weeks' gestation or underwent biventricular repair in the first year of life. Implementation of a digital monitoring platform that allows for secure monitoring of nasogastric feed advancement and oxygen saturation occurred in 2016, creating the two groups in a similar surgical era. RESULTS There were 38 patients who fell under a standard HMP compared to 31 utilizing the digital platform. There was no difference in baseline demographics, anatomy, or preoperative factors between the groups. Use of a digital platform was associated with reduced postoperative length of stay (30.1 vs 33.1 days, P = .04). More children in the digital platform monitoring group were able to achieve oral feeding at one year of age (90% vs 68%, P = .03). A total of 25% of infants went home with a nasogastric tube, all but one transitioning to full oral feeds. CONCLUSIONS Use of a digital, fully electronic medical record (EMR)-integrated, comprehensive HMP was associated with shorter postoperative length of stay in neonates undergoing staged single ventricle palliation and allowed for higher rates of full oral feeding.
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Vitamin D supplementation to palliative cancer patients: protocol of a double-blind, randomised controlled trial 'Palliative-D'.
Helde-Frankling, M, Bergqvist, J, Klasson, C, Nordström, M, Höijer, J, Bergman, P, Björkhem-Bergman, L
BMJ supportive & palliative care. 2017;(4):458-463
Abstract
BACKGROUND According to a small pilot study on palliative cancer patients at our ward, vitamin D supplementation had beneficial effects on pain (measured as opioid consumption), infections and quality of life (QoL) without having any significant side effects. OBJECTIVE The primary objective of the 'Palliative-D' study is to test the hypothesis that vitamin D supplementation for 12 weeks reduces opioid consumption. The secondary objectives are to study if reduction of antibiotic consumption and fatigue as well as improvement in QoL assessments can be observed. Effect on the 25-hydroxy vitamin D (25-OHD) levels in serum after 12 weeks of treatment will be studied, as well as the change in opioid dose in relation to genetic polymorphism in genes involved in the effect and metabolism of vitamin D. METHOD A randomised, double-blind placebo-controlled multicentre trial has been designed. The trial will include 254 adult palliative cancer patients with 25-OHD levels <50 nmol/L and a life expectancy of more than 3 months recruited from two advanced palliative home care centres in Stockholm. Included patients will be randomly assigned to 12 weeks of treatment with cholecalciferol (vitamin D3) 4000 IU/day or placebo. The study will start in November 2017 and will finish in December 2019. The study is approved by the Regional Ethical Committee, Dnr2017/405-31/1, by the Swedish Medical Products Agency, EudraCT: 2017-000268-14, and is registered at Clinicaltrial.gov: NCT03038516. The study is financed with research grants from the Swedish Cancer Society and the Stockholm County Council.
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Personalized symptom goals and response in patients with advanced cancer.
Hui, D, Park, M, Shamieh, O, Paiva, CE, Perez-Cruz, PE, Muckaden, MA, Bruera, E
Cancer. 2016;(11):1774-81
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BACKGROUND Improving symptoms is a major goal of cancer medicine; however, symptom response is often based on group differences and not individualized. In the current study, the authors examined the personalized symptom goal (PSG) for 10 common symptoms in patients with advanced cancer, and identified the factors associated with PSG response. METHODS In this prospective, longitudinal, multicenter study, patients from 5 tertiary care hospitals rated the intensity of 10 symptoms using a numeric rating scale of 0 to 10 at the time of their first clinic visit and then at a second visit 14 to 34 days later. The PSG was determined for each symptom by asking patients: "At what level would you feel comfortable with this symptom?" using the same scale of 0 to 10 for symptom intensity. PSG response was defined as symptom intensity at the time of the second visit that was less than or equal to the PSG. RESULTS Among 728 patients, the median PSG was 1 for nausea; 2 for depression, anxiety, drowsiness, well-being, dyspnea, and sleep; and 3 for pain, fatigue, and appetite. A greater percentage of patients achieved a PSG response at their second visit compared with their first visit (P<.05 except for drowsiness). Symptom response was associated with lower baseline symptom intensity based on PSG criterion but higher baseline symptom intensity based on the traditional minimal clinically important difference definition (P<.001 for all symptoms). In multivariable analysis, higher PSG and nationality were associated with greater PSG response. CONCLUSIONS The PSG was ≤3 for a majority of patients. PSG response allows clinicians to tailor treatment goals while adjusting for individual differences in scale interpretation and factors associated with symptom response. Cancer 2016;122:1774-81. © 2016 American Cancer Society.
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The effect of real-time electronic monitoring of patient-reported symptoms and clinical syndromes in outpatient workflow of medical oncologists: E-MOSAIC, a multicenter cluster-randomized phase III study (SAKK 95/06).
Strasser, F, Blum, D, von Moos, R, Cathomas, R, Ribi, K, Aebi, S, Betticher, D, Hayoz, S, Klingbiel, D, Brauchli, P, et al
Annals of oncology : official journal of the European Society for Medical Oncology. 2016;(2):324-32
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BACKGROUND Patients with advanced, incurable cancer receiving anticancer treatment often experience multidimensional symptoms. We hypothesize that real-time monitoring of both symptoms and clinical syndromes will improve symptom management by oncologists and patient outcomes. PATIENTS AND METHODS In this prospective multicenter cluster-randomized phase-III trial, patients with incurable, symptomatic, solid tumors, who received new outpatient chemotherapy with palliative intention, were eligible. Immediately before the weekly oncologists' visit, patients completed the palm-based E-MOSAIC assessment (Edmonton-Symptom-Assessment-Scale, ≤3 additional symptoms, estimated nutritional intake, body weight change, Karnofsky Performance Status, medications for pain, fatigue, nutrition). A cumulative, longitudinal monitoring sheet (LoMoS) was printed immediately. Eligible experienced oncologists were defined as one cluster each and randomized to receive the immediate print-out LoMoS (intervention) or not (control). Primary analysis limited to patients having uninterrupted (>4/6 visits with same oncologist) patient-oncologist sequences was a mixed model for the difference in patients global quality of life (G-QoL; items 29/30 of EORTC-QlQ-c30) between baseline (BL) and week 6. Intention-to-treat (ITT) analysis included all eligible patients. RESULTS In 8 centers, 82 oncologists treated 264 patients (median 66 years; overall survival intervention 6.3, control 5.4 months) with various tumors. The between-arm difference in G-QoL of 102 uninterrupted patients (intervention: 55; control: 47) was 6.8 (P = 0.11) in favor of the intervention; in a sensitivity analysis (oncologists treating ≥2 patients; 50, 39), it was 9.0 (P = 0.07). ITT analysis revealed improvement in symptoms (difference last study visit-BL: intervention -5.4 versus control 2.1, P = 0.003) and favored the intervention for communication and coping. More patients with high symptom load received immediate symptom management (chart review, nurse-patient interview) by oncologists getting the LoMoS. CONCLUSION Monitoring of patient symptoms, clinical syndromes and their management clearly reduced patients' symptoms, but not QoL. Our results encourage the implementation of real-time monitoring in the routine workflow of oncologist with a computer solution.
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Alternative forms of hydration in patients with cancer in the last days of life: study protocol for a randomised controlled trial.
Davies, A, Waghorn, M, Boyle, J, Gallagher, A, Johnsen, S
Trials. 2015;:464
Abstract
BACKGROUND The provision of clinically assisted hydration at the end of life is one of the most contentious issues in medicine, and indeed within the general population. The reasons for contention include: a) the lack of evidence for or against; b) the disparate opinions of healthcare professionals; and c) the generally positive opinions of patients and their carers about clinically assisted hydration. METHODS/DESIGN The study is a cluster randomised trial to assess the feasibility of conducting an adequately powered, randomised controlled trial of clinically assisted hydration in patients with cancer in the last days of life. Twelve sites, four National Health Service (NHS) hospitals and eight NHS/voluntary sector hospices in the United Kingdom, will be randomised to give either standard intervention A: continuance of oral intake and regular mouth care, or standard intervention B: continuance of oral intake, regular mouth care and clinically assisted hydration. Patients will be included if they: i) have a diagnosis of cancer; ii) are aged ≥ 18 yr; iii) have an estimated prognosis of ≤ 1 week and iv) are unable to maintain sufficient oral intake (1 L per day, measured/estimated); and v) are able to give informed consent. Patients will be excluded if they have contra-indications to receiving clinically assisted hydration. The primary endpoint of interest is the frequency of hyperactive delirium ('terminal agitation'), and this will be assessed using the Modified Richmond Agitation and Sedation Scale (administered every four hours). Other data to be collected include the frequency of pain, respiratory secretions ('death rattle'), dyspnoea, nausea and vomiting, adverse effects to clinically assisted hydration and overall survival. In addition, data will be collected on the use of anti-psychotic drugs, sedative drugs, analgesics, anti-secretory drugs and other end-of-life medication. The study has obtained full ethical approval. DISCUSSION A randomised controlled trial of clinically assisted hydration in end-of-life care is urgently required. This feasibility study will allow methodological and ethical issues to be understood and addressed to ensure that a robust, adequately powered, randomised controlled trial is designed. TRIAL REGISTRATION ClinicalTrials.gov NCT02344927 (registered 4 June 2014).
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Parenteral nutrition at the palliative phase of advanced cancer: the ALIM-K study protocol for a randomized controlled trial.
Pazart, L, Cretin, E, Grodard, G, Cornet, C, Mathieu-Nicot, F, Bonnetain, F, Mercier, M, Cuynet, P, Bouleuc, C, Aubry, R, et al
Trials. 2014;:370
Abstract
BACKGROUND Malnutrition is a common complication in patients at the palliative stage of cancer. During the curative phase of cancer, optimal enteral or parenteral nutrition intake can reduce morbidity and mortality, and improve quality of life. When the main goal of treatment becomes palliative, introduction of artificial nutrition is controversial. Although scientific societies do not recommend the introduction of artificial nutrition in all cases of malnutrition, especially in hypophagic patients if their life expectancy is shorter than 2 months, considerable differences in the use of parenteral nutrition in nonsurgical oncology practice are noted around the world. One explanation is a paucity of well-conducted randomized controlled trials in these situations, and consequently, the risk/benefit ratio of parenteral nutrition and its impact on quality of life in palliative care remains uncertain. METHODS/DESIGN The ALIM-K study is a French national multicenter randomized controlled trial designed to evaluate the effectiveness of parenteral nutrition, versus an exclusive oral-feeding supply, on the quality of life of malnourished patients who have a functional digestive tube and who are at the palliative phase of advanced cancer with a life expectancy of more than 2 months. DISCUSSION This article presents the methodologic options chosen for our study, and in particular, the choice of the Zelen method of randomization, the definition of the main end point (quality of life), the choice of comparator (oral feeding), and the inclusion criteria (life expectancy of more than 2 months), which are all critical points in building a randomized controlled trial in the setting of palliative care. TRIAL REGISTRATION This study was registered with the clinical trials database ClinicalTrials.gov on May 27, 2014, under the number NCT02151214.
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Management of inoperable malignant oesophageal strictures with fully covered WallFlex(®) stent: a multicentre prospective study.
Repici, A, Jovani, M, Hassan, C, Solito, B, Di Mitri, R, Buffoli, F, Macrì, G, Fregonese, D, Cennamo, V, De Bellis, M, et al
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2014;(12):1093-8
Abstract
BACKGROUND The majority of currently available oesophageal metal stents are partially covered to reduce migration risk. Preliminary experiences with fully covered stents seem to indicate an increased risk of migration in patients treated for malignant dysphagia. The aim of our study was to determine, in this setting, the safety and efficacy of a new, recently introduced stent with anti-migration proprieties. METHODS We designed a prospective, multicentre, non-randomized, follow-up study in nine tertiary referral centres. Eighty-two patients with dysphagia due to inoperable or metastatic oesophageal cancer were included. In all of them the fully covered WallFlex(®) stent was placed. Main outcome measurements included functional outcome, recurrent dysphagia, complications, and mortality. RESULTS Dysphagia score improved from a median of 3, before stenting, to 1 at 4 weeks after stent placement (P<0.001). Perforation occurred in 1 patient after 39 days, while bleeding was reported in 3. In total, 19 patients (23.1%) developed recurrent dysphagia because of stent migration (N=10, 12.2%), tissue overgrowth (N=7; 8.5%), and food impaction (N=2; 2.4%). CONCLUSIONS Placement of the fully covered WallFlex(®) stent resulted in safe and effective palliation of malignant dysphagia, with migration and tissue overgrowth rates comparable to previously reported data on partially covered stents.
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Combination of biodegradable stent placement and single-dose brachytherapy is associated with an unacceptably high complication rate in the treatment of dysphagia from esophageal cancer.
Hirdes, MM, van Hooft, JE, Wijrdeman, HK, Hulshof, MC, Fockens, P, Reerink, O, van Oijen, MG, van der Tweel, I, Vleggaar, FP, Siersema, PD
Gastrointestinal endoscopy. 2012;(2):267-74
Abstract
BACKGROUND For the palliative treatment of dysphagia, esophageal stent placement provides immediate improvement, whereas brachytherapy offers better long-term relief. OBJECTIVE To evaluate safety and efficacy of concurrent brachytherapy and biodegradable stent placement. DESIGN Prospective, single-arm study. SETTING Two tertiary-care referral centers. PATIENTS Nineteen consecutive patients with significant dysphagia resulting from unresectable esophageal cancer, with a life expectancy of more than 3 months. INTERVENTION Single-dose brachytherapy (12 Gy) on day 1 followed by biodegradable stent placement on day 2. MAIN OUTCOME MEASUREMENTS Intervention-related major complications (determined by an expert panel) and dysphagia. RESULTS Nineteen patients (13 men, median age 66 years [interquartile range (IQR) 59-71] years) were included; 7 patients (37%) also received palliative chemotherapy. After inclusion of 19 patients, the study was ended prematurely because the safety threshold was exceeded. In total, 28 major complications occurred in 17 patients (89%). In 9 patients (47%), major complications were determined intervention-related (severe retrosternal pain with or without vomiting [n = 6], hematemesis [n = 1], recurrent dysphagia [n = 2]. Dysphagia scores decreased significantly from a median of 3 (IQR 3-4) to a median of 1 (IQR 0-3) after 1 month (P < .001). Despite adequate luminal patency in 17 patients (89%), normal diet could not be tolerated in 7 patients (37%) because of retrosternal pain and vomiting. LIMITATIONS Lack of routine endoscopy or contrast esophagram to evaluate recurrent dysphagia during follow-up. CONCLUSION Despite restoration of luminal patency, a combined treatment of brachytherapy and biodegradable stent placement cannot be recommended for the palliative treatment of esophageal cancer because of an unacceptably high intervention-related major complication rate.
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Oral intake throughout the patients' lives after palliative metallic stent placement for malignant gastroduodenal obstruction: a retrospective multicentre study.
Canena, JM, Lagos, AC, Marques, IN, Patrocínio, SD, Tomé, MG, Liberato, MA, Romão, CM, Coutinho, AP, Veiga, PM, Neves, BC, et al
European journal of gastroenterology & hepatology. 2012;(7):747-55
Abstract
OBJECTIVES Patients with inoperable malignant gastric outlet obstruction (GOO) have been managed with self-expandable metal stents to improve oral intake. Recent studies have shown conflicting results on the capacity of self-expandable metal stents to restore food intake in the long term. This study evaluated the clinical effectiveness of enteral stent placement for GOO throughout the patients' lives. METHODS This was a multicentre, retrospective study with a long-term follow-up of 74 patients who underwent enteral stenting for symptomatic GOO. Data were collected to analyse improvements in oral intake for the patients' entire lives as assessed by the GOO scoring system (GOOSS), technical success, stent patency, complications, the need for reintervention, survival and the prognostic factors associated with stent patency. RESULTS Technical and clinical success was achieved in 100 and 97.2% of the patients, respectively. A total of 71/74 patients (95.9%) continued oral intake for the rest of their lives and 58/74 patients (78.4%) needed no further intervention until death. Solid food intake (GOOSS 2-3) continued until death in 47/74 patients (63.5%). The GOOSS score improved (P<0.001) during the follow-up compared with the baseline. The median survival and the mean stent patency were 8 and 76.6 weeks, respectively. The complication rate was 18.9%. Malignant stent reobstruction was observed in 7/74 patients (9.5%). A Cox multivariate analysis showed that duodenal location of the obstruction was the only independent factor associated with stent patency (hazard ratio=5.28; 95% confidence interval=1.14-24.45; P=0.033). CONCLUSION Enteral stenting in patients with unresectable GOO is safe and clinically effective. Ninety-five per cent of patients are able to resume oral intake for the rest of their lives, and the great majority remain free from further intervention. In approximately two-thirds of patients, solid food intake continues until death.