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A randomised controlled trial to assess whether prehabilitation improves fitness in patients undergoing neoadjuvant treatment prior to oesophagogastric cancer surgery: study protocol.

ABSTRACT: INTRODUCTION:Neoadjuvant therapy prior to oesophagogastric resection is the gold standard of care for patients with T2 and/or nodal disease. Despite this, studies have taught us that chemotherapy decreases patients' functional capacity as assessed by cardiopulmonary exercise (CPX) testing. We aim to show that a multimodal prehabilitation programme, comprising supervised exercise, psychological coaching and nutritional support, will physically, psychologically and metabolically optimise these patients prior to oesophagogastric cancer surgery so they may better withstand the immense physical and metabolic stress placed on them by radical curative major surgery. METHODS AND ANALYSIS:This will be a prospective, randomised, controlled, parallel, single-centre superiority trial comparing a multimodal 'prehabilitation' intervention with 'standard care' in patients with oesophagogastric malignancy who are treated with neoadjuvant therapy prior to surgical resection. The primary aim is to demonstrate an improvement in baseline cardiopulmonary function as assessed by anaerobic threshold during CPX testing in an interventional (prehab) group following a 15-week preoperative exercise programme, throughout and following neoadjuvant treatment, when compared with those that undergo standard care (control group). Secondary objectives include changes in peak oxygen uptake and work rate (total watts achieved) at CPX testing, insulin resistance, quality of life, chemotherapy-related toxicity and completion, nutritional assessment, postoperative complication rate, length of stay and overall mortality. ETHICS AND DISSEMINATION:This study has been approved by the London-Bromley Research Ethics Committee and registered on ClinicalTrials.gov. The results will be disseminated in a peer-reviewed journal. TRIAL REGISTRATION NUMBER:NCT02950324; Pre-results.

SUBMITTER: Allen S

PROVIDER: S-EPMC6318540 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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A randomised controlled trial to assess whether prehabilitation improves fitness in patients undergoing neoadjuvant treatment prior to oesophagogastric cancer surgery: study protocol.

Allen Sophie S Brown Vanessa V Prabhu Pradeep P Scott Michael M Rockall Timothy T Preston Shaun S Sultan Javed J

BMJ open 20181222 12

<h4>Introduction</h4>Neoadjuvant therapy prior to oesophagogastric resection is the gold standard of care for patients with T2 and/or nodal disease. Despite this, studies have taught us that chemotherapy decreases patients' functional capacity as assessed by cardiopulmonary exercise (CPX) testing. We aim to show that a multimodal prehabilitation programme, comprising supervised exercise, psychological coaching and nutritional support, will physically, psychologically and metabolically optimise t ...[more]

PMID: 30580268

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Project description:BackgroundBreast cancer surgery results in numerous acute and long-term adverse outcomes; the degree to which these can be mitigated or prevented through prehabilitation is unknown.MethodsWe conducted a longitudinal, single-arm, mixed-methods study to examine the feasibility of prehabilitation in 22 women undergoing breast cancer surgery. All participants received an individualized exercise prescription including upper quadrant-specific resistance and mobility training and aerobic exercise for the duration of their surgical wait time. Feasibility was assessed by recruitment, adherence, attrition, and intervention-related adverse event rates. An exploratory investigation of intervention efficacy was conducted via a 6-min walk test, upper-quadrant strength and range of motion, volumetric chances associated with lymphedema, and participant-reported quality of life, fatigue, pain, and disability. Outcome assessments were conducted at baseline, prior to surgery, and at six and 12 weeks after surgery. Semi-structured interviews with a subset of participants (n = 5) and health-care providers (H; n = 2) were conducted to provide further insights about intervention feasibility. Qualitative data were analyzed using a hybrid inductive and deductive thematic analysis approach.ResultsRecruitment and attrition rates were 62 and 36%, respectively. Average prehabilitation duration was 31 days (range = 7-69 days). Seventy six percent of participants complied with at least 70% of their prehabilitation prescription. There was a clinically significant increase in the 6-min walk distance from baseline to the preoperative assessment (57 m, 95% CI = -7.52, 121.7). The interviews revealed that the intervention was favorably received by participants and HCPs and included suggestions that prehabilitation (i) should be offered to all surgical candidates, (ii) is an avenue to regain control in the preoperative period, (iii) is a facilitator of postoperative recovery, and (iv) is an opportunity to provide education regarding postoperative rehabilitation protocols. A preference for multimodal prehabilitation (including dietetic and psychological counseling) was also highlighted.ConclusionOur findings suggest that surgical prehabilitation in women with breast cancer is feasible. Data are hampered by study sample size and lack of a control group. Thus, randomized controlled trials to examine prehabilitation efficacy in people with breast cancer, especially interventions employing a multimodal strategy, are warranted.

Project description:Objective To assess the potential cost-effectiveness of prehabilitation in medically frail patients undergoing surgery for epithelial ovarian cancer (EOC). Methods We created a cost-effectiveness model evaluating the impact of prehabilitation on a cohort of medically frail women undergoing primary surgical intervention for EOC. Cost was assessed from the healthcare system perspective via (1) inpatient charges from 2018–2019 institutional Diagnostic Related Grouping data for surgeries with and without major complications; (2) nursing facility costs from published market surveys. Major complication and non-home discharge rates were estimated from the literature. Based on published pilot studies, prehabilitation was determined to decrease these rates. Incremental cost-effectiveness ratio for cost per life year saved utilized a willingness-to-pay threshold of $100,000/life year. Modeling was performed with TreeAge software. Results In a cohort of 4,415 women, prehabilitation would cost $371.1 Million (M) versus $404.9 M for usual care, a cost saving of $33.8 M/year. Cost of care per patient with prehabilitation was $84,053; usual care was $91,713. When analyzed for cost-effectiveness, usual care was dominated by prehabilitation, indicating prehabilitation was associated with both increased effectiveness and decreased cost compared with usual care. Sensitivity analysis showed prehabilitation was more cost effective up to a cost of intervention of $9,418/patient. Conclusion Prehabilitation appears to be a cost-saving method to decrease healthcare system costs via two improved outcomes: lower complication rates and decreased care facility requirements. It represents a novel strategy to optimize healthcare efficiency. Prospective studies should be performed to better characterize these interventions in medically frail patients with EOC. Synopsis Prehabilitation cost-effectiveness analysis was performed for medically frail epithelial ovarian cancer patients undergoing surgery. It was cost-saving for the healthcare system via lower complication rates and discharge care requirements. Prehabilitation was cost effective up to a cost of $9,418/patient.

Project description:BackgroundPrehabilitation is a promising modality for improving patient-related outcomes after major surgery; however, very little research has been done for those who may need it the most: the elderly and the frail. This study aimed to investigate the feasibility of a short course multimodal prehabilitation prior to primary surgery in high-risk, frail patients with colorectal cancer and WHO performance status I and II.MethodsThe study was conducted as a single-center, prospective one-arm feasibility study of eight patients with colon cancer between October 4, 2018, and January 14, 2019. The intervention consisted of a physical training program tailored to the patients with both high-intensity interval training and resistance training three times a week in sessions of approximately 1 h in length, for a duration of at least 4 weeks, nutritional support with protein and vitamins, a consultation with a dietician, and medical optimization prior to surgery. Feasibility was evaluated regarding recruitment, retention, compliance and adherence, acceptability, and safety. Retention was evaluated as the number of patients that completed the intervention, with a feasibility goal of 75% completing the intervention. Compliance with the high-intensity training was evaluated as the number of sessions in which the patient achieved a minimum of 4 min > 90% of their maximum heart rate and adherence as the attended out of the offered training sessions.ResultsDuring the study period, 64 patients were screened for eligibility, and out of nine eligible patients, eight patients were included and seven completed the intervention (mean age 80, range 66-88). Compliance to the high-intensity interval training using 90% of maximum heart rate as the monitor of intensity was difficult to measure in several patients; however, adherence to the training sessions was 87%. Compliance with nutritional support was 57%. Half the patients felt somewhat overwhelmed by the multiple appointments and six out of seven reported difficulties with the dosage of protein.ConclusionsThis one-arm feasibility study indicates that multimodal prehabilitation including high-intensity interval training can be performed by patients with colorectal cancer and WHO performance status I and II.Trial registrationClinicaltrials.gov : the study current feasibility study was conducted prior to the initiation of a full ongoing randomized trial registered by NCT04167436; date of registration: November 18, 2019. Retrospectively registered. No separate prospectively registration of the feasibility trial was conducted but outlined by the approved study protocol (Danish Scientific Ethical Committee SJ-607).

Project description:IntroductionUndergoing major surgery can induce physical and functional decline. Prehabilitation programmes aim to improve physical fitness and function preoperatively and could enhance postoperative recovery and outcomes. Prehabilitation interventions have been utilised across a range of orthopaedic populations of all ages and can be multimodal in nature. The aim of this study is to evaluate the effectiveness of prehabilitation for patients undergoing orthopaedic surgery including day surgery procedures. It will also investigate the components of prehabilitation to understand optimum duration and frequency of programmes.Methods/designSystematic review and meta-analysis designed in accordance with Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. A comprehensive electronic search will be performed in MEDLINE, CINAHL, AMED, Embase, PEDro and Cochrane CENTRAL databases in order to identify randomised control trials published between January 2000 to 25 March 2019. ISI Web of Science, System for information on grey literature and the European Union clinical trials registry will identify studies that are underway or unpublished. Two independent reviewers will carry out the searches, study selection (title and abstract and full text stages), data extraction, risk of bias assessment (Cochrane Risk of Bias tool 2.0) and evaluation of overall strength of evidence. Meta-analyses will be used for data which demonstrates homogeneity, otherwise a narrative synthesis will be performed for groups of studies of high heterogeneity (I2 >50%). The overall strength of the body of evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation.Ethics and disseminationThis study raises no ethical issues. This study aims to identify the effectiveness of prehabilitation interventions and may assist clinicians in determining which components, duration, frequency and the method of delivery would form the most effective prehabilitation intervention for patients undergoing an orthopaedic surgical procedure. The findings will be disseminated through publication in a peer-reviewed journal and conference presentations.Prospero registration numberCRD42019123268.

Project description:BACKGROUND:Body composition assessment, measured using single-slice computed tomography (CT) image at L3 level, and aerobic physical fitness, objectively measured using cardiopulmonary exercise testing (CPET), are each independently used for perioperative risk assessment. Sarcopenia (i.e. low skeletal muscle mass), myosteatosis [i.e. low skeletal muscle radiation attenuation (SM-RA)], and impaired objectively measured aerobic fitness (reduced oxygen uptake) have been associated with poor post-operative outcomes and survival in various cancer types. However, the association between CT body composition and physical fitness has not been explored. In this study, we assessed the association of CT body composition with selected CPET variables in patients undergoing hepatobiliary and pancreatic surgery. METHODS:A pragmatic prospective cohort of 123 patients undergoing hepatobiliary and pancreatic surgery were recruited. All patients underwent preoperative CPET. Preoperative CT scans were analysed using a single-slice CT image at L3 level to assess skeletal muscle mass, adipose tissue mass, and muscle radiation attenuation. Multivariate linear regression was used to test the association between CPET variables and body composition. Main outcomes were oxygen uptake at anaerobic threshold ( V? O2 at AT), oxygen uptake at peak exercise ( V? O2 peak), skeletal muscle mass, and SM-RA. RESULTS:Of 123 patients recruited [77 men (63%), median age 66.9 ± 11.7, median body mass index 27.3 ± 5.2], 113 patients had good-quality abdominal CT scans available and were included. Of the CT body composition variables, SM-RA had the strongest correlation with V? O2 peak (r = 0.57, P < 0.001) and V? O2 at AT (r = 0.45, P < 0.001) while skeletal muscle mass was only weakly associated with V? O2 peak (r = 0.24, P < 0.010). In the multivariate analysis, only SM-RA was associated with V? O2 peak (B = 0.25, 95% CI 0.15-0.34, P < 0.001, R2 = 0.42) and V? O2 at AT (B = 0.13, 95% CI 0.06-0.18, P < 0.001, R2 = 0.26). CONCLUSIONS:There is a positive association between preoperative CT SM-RA and preoperative physical fitness ( V? O2 at AT and at peak). This study demonstrates that myosteatosis, and not sarcopenia, is associated with reduced aerobic physical fitness. Combining both myosteatosis and physical fitness variables may provide additive risk stratification accuracy and guide interventions during the perioperative period.

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A randomised controlled trial to assess whether prehabilitation improves fitness in patients undergoing neoadjuvant treatment prior to oesophagogastric cancer surgery: study protocol.

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A randomised controlled trial to assess whether prehabilitation improves fitness in patients undergoing neoadjuvant treatment prior to oesophagogastric cancer surgery: study protocol.

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