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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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A new model of early, integrated palliative care: palliative rehabilitation for newly diagnosed patients with non-resectable cancer.
Nottelmann, L, Jensen, LH, Vejlgaard, TB, Groenvold, M
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2019;(9):3291-3300
Abstract
PURPOSE The aim of this paper is to describe a model of palliative rehabilitation for newly diagnosed advanced cancer patients and present data on how it was utilised during a randomised controlled trial (RCT). METHODS We designed a highly flexible, multidisciplinary model of palliative rehabilitation consisting of a "basic offer" and tailored elements. The model was evaluated in the setting on an RCT investigating the effect of systematic referral to a palliative rehabilitation clinic concurrently with standard oncology treatment or standard treatment alone. The basic offer of palliative rehabilitation was two consultations and a 12-week possibility of contacting a palliative rehabilitation team, if needed. In addition, patients and family caregivers could be offered participation in a 12-week patient/caregiver school combined with individually tailored physical exercise in groups, individual consultations, or both. Contacts with the palliative rehabilitation team and participant evaluation were registered prospectively. RESULTS Between December 2014 and December 2017, 132 adults with newly diagnosed advanced cancer were seen in the palliative rehabilitation outpatient clinic. Twenty percent of the participants received the basic offer only (n = 26), 45% additionally participated in the group program (n = 59), and 35% received supplementary individual consultations without participating in the group program (n = 47). The intervention was primarily led by nurses, and the main themes of the individual consultations were coping, pain, and nutrition. When asked if they would recommend the intervention to others in the same situation, 93% of the respondents agreed, 7% partly agreed, and no one disagreed. CONCLUSION The new model of palliative rehabilitation presented here had a flexibility to meet the needs of the participants and led to a very high degree of patient satisfaction. It could serve as an inspiration to other cancer centres wanting to integrate palliative care into standard oncology services.
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Effect of early and systematic integration of palliative care in patients with advanced cancer: a randomised controlled trial.
Vanbutsele, G, Pardon, K, Van Belle, S, Surmont, V, De Laat, M, Colman, R, Eecloo, K, Cocquyt, V, Geboes, K, Deliens, L
The Lancet. Oncology. 2018;(3):394-404
Abstract
BACKGROUND The benefit of early integration of palliative care into oncological care is suggested to be due to increased psychosocial support. In Belgium, psychosocial care is part of standard oncological care. The aim of this randomised controlled trial is to examine whether early and systematic integration of palliative care alongside standard psychosocial oncological care provides added benefit compared with usual care. METHODS In this randomised controlled trial, eligible patients were 18 years or older, and had advanced cancer due to a solid tumour, an European Cooperative Oncology Group performance status of 0-2, an estimated life expectancy of 12 months, and were within the first 12 weeks of a new primary tumour or had a diagnosis of progression. Patients were randomly assigned (1:1), by block design using a computer-generated sequence, either to early and systematic integration of palliative care into oncological care, or standard oncological care alone in a setting where all patients are offered multidisciplinary oncology care by medical specialists, psychologists, social workers, dieticians, and specialist nurses. The primary endpoint was change in global health status/quality of life scale assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ C30) at 12 weeks. The McGill Quality of Life Questionnaire (MQOL), which includes the additional existential wellbeing dimension, was also used. Analysis was by intention to treat. This trial is ongoing, but closed for accrual, and is registered with ClinicalTrials.gov, number NCT01865396. FINDINGS From April 29, 2013, to Feb 29, 2016, we screened 468 patients for eligibility, of whom 186 were enrolled and randomly assigned to the early and systematic palliative care group (92 patients) or the standard oncological care group (94). Compliance at 12 weeks was 71% (65 patients) in the intervention group versus 72% (68) in the control group. The overall quality of life score at 12 weeks, by the EORTC QLQ C30, was 54·39 (95% CI 49·23-59·56) in the standard oncological care group versus 61·98 (57·02-66·95) in the early and systematic palliative care group (difference 7·60 [95% CI 0·59-14·60]; p=0·03); and by the MQOL Single Item Scale, 5·94 (95% CI 5·50-6·39) in the standard oncological care group versus 7·05 (6·59-7·50) in the early and systematic palliative care group (difference 1·11 [95% CI 0·49-1·73]; p=0.0006). INTERPRETATION The findings of this study show that a model of early and systematic integration of palliative care in oncological care increases the quality of life of patients with advanced cancer. Our findings also show that early and systematic integration of palliative care is more beneficial for patients with advanced cancer than palliative care consultations offered on demand, even when psychosocial support has already been offered. Through integration of care, oncologists and specialised palliative care teams should work together to enhance the quality of life of patients with advanced cancer. FUNDING Research Foundation Flanders, Flemish Cancer Society (Kom Op Tegen Kanker).
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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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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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Improving Quality of Life for People with Incurable Large-Bowel Obstruction: Randomized Control Trial of Colonic Stent Insertion.
Young, CJ, De-Loyde, KJ, Young, JM, Solomon, MJ, Chew, EH, Byrne, CM, Salkeld, G, Faragher, IG
Diseases of the colon and rectum. 2015;(9):838-49
Abstract
BACKGROUND Surgery remains the dominant treatment for large-bowel obstruction, with emerging data on self-expanding metallic stents. OBJECTIVE The aim of this study was to assess whether stent insertion improves quality of life and survival in comparison with surgical decompression. DESIGN This study reports on a randomized control trial (registry number ACTRN012606000199516). SETTING This study was conducted at Royal Prince Alfred Hospital, Sydney, and Western Hospital, Melbourne. PATIENTS AND INTERVENTION Patients with malignant incurable large-bowel obstruction were randomly assigned to surgical decompression or stent insertion. MAIN OUTCOME MEASURES The primary end point was differences in EuroQOL EQ-5D quality of life. Secondary end points included overall survival, 30-day mortality, stoma rates, postoperative recovery, complications, and readmissions. RESULTS Fifty-two patients of 58 needed to reach the calculated sample size were evaluated. Stent insertion was successful in 19 of 26 (73%) patients. The remaining 7 patients required a stoma compared with 24 of 26 (92%) surgery group patients (p < 0.001). There were no stent-related perforations or deaths. The surgery group had significantly reduced quality of life compared with the stent group from baseline to 1 and 2 weeks (p = 0.001 and p = 0.012), and from baseline to 12 months (p = 0.01) in favor of the stent group, whereas both reported reduced quality of life. The stent group had an 8% 30-day mortality compared with 15% for the surgery group (p = 0.668). Median survival was 5.2 and 5.5 months for the groups (p = 0.613). The stent group had significantly reduced procedure time (p = 0.014), postprocedure stay (p = 0.027), days nothing by mouth (p = 0.002), and days before free access to solids (p = 0.022). LIMITATIONS This study was limited by the lack of an EQ-5D Australian-based population set. CONCLUSIONS Stent use in patients with incurable large-bowel obstruction has a number of advantages with faster return to diet, decreased stoma rates, reduced postprocedure stay, and some quality-of-life benefits.
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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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Potential benefits of early nutritional intervention in adults with upper gastrointestinal cancer: a pilot randomised trial.
Silvers, MA, Savva, J, Huggins, CE, Truby, H, Haines, T
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2014;(11):3035-44
Abstract
PURPOSE This study aimed to test whether a very early nutrition intervention delivered over the telephone was feasible and could improve outcomes amongst patients with upper gastrointestinal cancer. METHODS Participants with a histologically proven new diagnosis of primary oesophageal or stomach cancer and who were to undergo surgery and/or chemotherapy were randomised to receive either standard nutrition care (SC) or early and intensive nutrition intervention (NI) over the telephone/face-to-face. Participants were followed for 6 months. The primary outcome was quality of life (QoL), assessed using the European Organization for Research and Treatment of Cancer Global Quality of Life questionnaire C30 (EORTC QLQ-C30) and the European Quality of Life Instrument (EQ-5D) tool; secondary outcomes were nutritional status and survival. RESULTS Twenty-one participants were recruited (11 SC and 10 NI). At baseline, the prevalence of malnutrition was 90 %. Compared with SC, the NI group had a significantly higher EORTC global QoL score at the first mid-study follow-up (coefficient (95 % CI) 21.0 (12.1, 29.9) adjusted for baseline, p < 0.001) and at 26 weeks (28.4 (21.3, 35.4) adjusted for baseline, p < 0.001). Nutritional risk score was lower (p < 0.001), and loss of body weight attenuated (p < 0.001) in the NI group compared with SC. Six deaths occurred during the study, five in the SC group and one in the NI group (p = 0.06). The mean time spent with a dietitian per contact was significantly less for the NI group compared with SC (16(3) vs 40(6) min per dietetic contact, p < 0.001). CONCLUSIONS This pilot study has shown the potential of a novel telephone-based early and intensive dietetic model of care for newly diagnosed upper gastrointestinal cancer patients.
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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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Effects of professional oral health care on reducing the risk of chemotherapy-induced oral mucositis.
Saito, H, Watanabe, Y, Sato, K, Ikawa, H, Yoshida, Y, Katakura, A, Takayama, S, Sato, M
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2014;(11):2935-40
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PURPOSE Recent years have seen remarkable progress in cancer therapy, although treatment-induced adverse reactions and complications are not uncommon. Approximately 40 % of patients undergoing chemotherapy for cancer experience adverse reactions in the oral cavity, with nearly half of them developing severe oral mucositis that necessitates postponing therapy and/or changing the drug dosage. The objective of this study was to assess the usefulness of prophylactic professional oral health care (POHC) for preventing mucositis in patients undergoing chemotherapy. METHODS Twenty-six female patients scheduled for chemotherapy for breast cancer were included in this study and randomized to the self-care or POHC groups. Assessment parameters included oral cavity photographs, plaque control records, Saxon test scores, Oral Assessment Guide scores, and grading using the Common Terminology Criteria for Adverse Events. Beginning before surgery and continuing through the completion of chemotherapy, the POHC patient group received weekly professional oral health care, including scaling, professional cleaning of the tooth surfaces, brushing instructions, and nutritional and lifestyle guidance. RESULTS More patients in the self-care group developed oral mucositis than in the POHC group. The Oral Assessment Guide score, which was used as an index of oral mucositis, was also significantly lower in the POHC group. Based on the Oral Assessment Guide and plaque control records, there was almost no deterioration of the oral environment in the POHC group, whereas deterioration was observed in the self-care group. CONCLUSIONS These findings demonstrate the efficacy of regular POHC in reducing the risk of oral mucositis in breast cancer patients undergoing chemotherapy.