Effect of Multimodal Prehabilitation on Reducing Postoperative Complications and Enhancing Functional Capacity Following Colorectal Cancer Surgery: The PREHAB Randomized Clinical Trial.

Importance: Colorectal surgery is associated with substantial morbidity rates and a lowered functional capacity. Optimization of the patient's condition in the weeks prior to surgery may attenuate these unfavorable sequelae. Objective: To determine whether multimodal prehabilitation before colorectal cancer surgery can reduce postoperative complications and enhance functional recovery. Design, Setting, and Participants: The PREHAB randomized clinical trial was an international, multicenter trial conducted in teaching hospitals with implemented enhanced recovery after surgery programs. Adult patients with nonmetastasized colorectal cancer were assessed for eligibility and randomized to either prehabilitation or standard care. Both arms received standard perioperative care. Patients were enrolled from June 2017 to December 2020, and follow-up was completed in December 2021. However, this trial was prematurely stopped due to the COVID-19 pandemic. Interventions: The 4-week in-hospital supervised multimodal prehabilitation program consisted of a high-intensity exercise program 3 times per week, a nutritional intervention, psychological support, and a smoking cessation program when needed. Main Outcomes and Measures: Comprehensive Complication Index (CCI) score, number of patients with CCI score more than 20, and improved walking capacity expressed as the 6-minute walking distance 4 weeks postoperatively. Results: In the intention-to-treat population of 251 participants (median [IQR] age, 69 [60-76] years; 138 [55%] male), 206 (82%) had tumors located in the colon and 234 (93%) underwent laparoscopic- or robotic-assisted surgery. The number of severe complications (CCI score >20) was significantly lower favoring prehabilitation compared with standard care (21 of 123 [17.1%] vs 38 of 128 [29.7%]; odds ratio, 0.47 [95% CI, 0.26-0.87]; P = .02). Participants in prehabilitation encountered fewer medical complications (eg, respiratory) compared with participants receiving standard care (19 of 123 [15.4%] vs 35 of 128 [27.3%]; odds ratio, 0.48 [95% CI, 0.26-0.89]; P = .02). Four weeks after surgery, 6-minute walking distance did not differ significantly between groups when compared with baseline (mean difference prehabilitation vs standard care 15.6 m [95% CI, -1.4 to 32.6]; P = .07). Secondary parameters of functional capacity in the postoperative period generally favored prehabilitation compared with standard care. Conclusions and Relevance: This PREHAB trial demonstrates the benefit of a multimodal prehabilitation program before colorectal cancer surgery as reflected by fewer severe and medical complications postoperatively and an optimized postoperative recovery compared with standard care. Trial Registration: trialregister.nl Identifier: NTR5947.

Virtual Prehabilitation in Patients With Cancer Undergoing Surgery During the COVID-19 Pandemic: Protocol for a Prospective Feasibility Study.

BACKGROUND: Since the beginning of the COVID-19 pandemic, preoperative care, also termed prehabilitation, has become increasingly relevant due to the decreasing functional and psychosocial health of patients with cancer, which is a result of the pandemic restrictions. Concurrently, access to telehealth has improved; telehealth comprises all remote care delivery facilitated by information technologies (ie, virtually). OBJECTIVE: The aim of this protocol is to describe the rationale and methodology for a major trial investigating the feasibility and safety of multimodal virtual prehabilitation services (ie, teleprehabilitation). METHODS: This single-arm feasibility trial aims to recruit 100 patients with cancer to receive teleprehabilitation throughout their preoperative period. The inclusion criteria are as follows: (1) 18 years of age or older, (2) scheduled for elective cancer surgery and referred by a surgeon, (3) medically cleared by the referring physician to engage in physical activity, and (4) have a good comprehension of the English or French language. Feasibility will be assessed by documenting recruitment, adherence, and retention rates, in addition to patients' motives for not participating in the trial, low participation, or discontinuation. The secondary outcome of safety will be assessed by reporting program-related adverse events. RESULTS: The Montreal General Hospital Foundation funded the project in August 2020. The protocol was then approved by the Research Ethics Board of the McGill University Health Centre in January 2021 (ID No. 2021-6730). The first patient was recruited in March 2021, and recruitment is expected to end in September 2022. As of March 2022, 36 patients have been recruited, including 24 who have completed their participation. No adverse events have been reported. Data collection is expected to conclude in November 2022. Data analysis will be performed, and the results will be published by the beginning of 2023. CONCLUSIONS: This trial will provide guidance on the use of telehealth in the administration of prehabilitation services. The trial will provide a large amount of information that will respond to gaps in the literature, as there are minimal reports on the use of telehealth rehabilitation and prehabilitation services among elderly populations and in acute contexts, such as the preoperative period. TRIAL REGISTRATION: ClinicalTrials.gov NCT0479956; https://clinicaltrials.gov/ct2/show/NCT04799561. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/29936.

Successes and challenges of implementing teleprehabilitation for onco-surgical candidates and patients’ experience: a retrospective pilot-cohort study

This study documents the implementation of a multimodal teleprehabilitation program (e.g., completion rate, exercise metrics, and program successes and challenges) for cancer patients undergoing surgery. It also documents the patients’ experience of the program. This pilot-cohort study included adults scheduled for elective thoracic and abdominal cancer resection surgery, referred to the prehabilitation clinic to engage in physical activity, and received a teleprehabilitation program between August 1st, 2020, and February 28th, 2021. The technology platform provided to the patients included a tablet and a wearable device to facilitate communication and data collection. Data collected for this article were acquired through virtual physical activity monitoring in addition to patient charts. Qualitative data collected comprised of successes and challenges of implanting a teleprehabilitation program, in addition to patients’ perspectives of the program. Quantitative data collected comprised of the exercise metrics, perioperative functional outcomes, in addition to the surgical and postoperative outcomes. Ten patients (8 males and 2 females;mean age: 68.3 years, SD 11.96) diagnosed with various thoracoabdominal malignancies were included in the current descriptive study. The successes identified were related to recruitment and assessment, improvement in functional capacity, clinic scheduling and interventions, and optimal medical follow-up. The challenges identified were related to the adoption of the technologies by patients and the multidisciplinary team, the accurate acquisition of patient physical activity data, and the initial costs to acquire the new technologies. Patients were satisfied with the teleprehabilitation program (i.e., services delivered;average appreciation: 96%), and they perceived the technologies provided to be 90% user-friendly. The findings of the current study highlight important concepts in view of the current international health paradigm changes prioritizing remote interventions facilitated through digital communication technologies. It provides important insight into the clinical application of telehealth in elderly populations, notably in the context of acute preoperative cancer care. This article may provide guidance for other cancer care facilities aiming to implement teleprehabilitation programs.

BNT162b2 vaccine induces antibody release in saliva: a possible role for mucosal viral protection?

Vaccination against an airborne pathogen is very effective if it induces also the development of mucosal antibodies that can protect against infection. The mRNA-based vaccine-encoding SARS-CoV-2 full-length spike protein (BNT162b2, Pfizer/BioNTech) protects also against infection despite being administered systemically. Here, we show that upon vaccination, cognate IgG molecules are also found in the saliva and are more abundant in SARS-CoV-2 previously exposed subjects, paralleling the development of plasma IgG. The antibodies titer declines at 3 months from vaccination. We identified a concentration of specific IgG in the plasma above which the relevant IgG can be detected in the saliva. Regarding IgA antibodies, we found only protease-susceptible IgA1 antibodies in plasma while they were present at very low levels in the saliva over the course of vaccination of SARS-CoV-2-naïve subjects. Thus, in response to BNT162b2 vaccine, plasma IgG can permeate into mucosal sites and participate in viral protection. It is not clear why IgA1 are detected in low amount, they may be proteolytically cleaved.

A 'Multiomic' Approach of Saliva Metabolomics, Microbiota, and Serum Biomarkers to Assess the Need of Hospitalization in Coronavirus Disease 2019.

BACKGROUND AND AIMS: The SARS-CoV-2 pandemic has overwhelmed the treatment capacity of the health care systems during the highest viral diffusion rate. Patients reaching the emergency department had to be either hospitalized (inpatients) or discharged (outpatients). Still, the decision was taken based on the individual assessment of the actual clinical condition, without specific biomarkers to predict future improvement or deterioration, and discharged patients often returned to the hospital for aggravation of their condition. Here, we have developed a new combined approach of omics to identify factors that could distinguish coronavirus disease 19 (COVID-19) inpatients from outpatients. METHODS: Saliva and blood samples were collected over the course of two observational cohort studies. By using machine learning approaches, we compared salivary metabolome of 50 COVID-19 patients with that of 270 healthy individuals having previously been exposed or not to SARS-CoV-2. We then correlated the salivary metabolites that allowed separating COVID-19 inpatients from outpatients with serum biomarkers and salivary microbiota taxa differentially represented in the two groups of patients. RESULTS: We identified nine salivary metabolites that allowed assessing the need of hospitalization. When combined with serum biomarkers, just two salivary metabolites (myo-inositol and 2-pyrrolidineacetic acid) and one serum protein, chitinase 3-like-1 (CHI3L1), were sufficient to separate inpatients from outpatients completely and correlated with modulated microbiota taxa. In particular, we found Corynebacterium 1 to be overrepresented in inpatients, whereas Actinomycetaceae F0332, Candidatus Saccharimonas, and Haemophilus were all underrepresented in the hospitalized population. CONCLUSION: This is a proof of concept that a combined omic analysis can be used to stratify patients independently from COVID-19.

Feasibility of a novel mixed-nutrient supplement in a multimodal prehabilitation intervention for lung cancer patients awaiting surgery: A randomized controlled pilot trial.

OBJECTIVE: To investigate, in lung cancer patients awaiting elective surgery, the feasibility of delivering a novel four-week multimodal prehabilitation intervention and its effects on preoperative functional capacity and health-related quality of life (HRQoL), compared to standard hospital care. METHODS: Adult patients awaiting elective thoracotomy for lung cancer stages I, II or IIIa, were approached to participate in an open-label, randomized controlled trial of two parallel arms: multimodal prehabilitation combining a mixed-nutrient supplement with structured supervised and home-based exercise training, and relaxation-strategies (Prehab) or standard hospital care (Control). Feasibility was assessed based on recruitment and adherence rates to the intervention and study outcome assessment. Functional capacity, measured by the 6-min walk test (6MWT), and HRQoL were measured at baseline and after four weeks (preoperative). RESULTS: Within 5 months, 34 patients were enrolled and randomized (2:1) to Prehab (n = 24; median age = 67 years) or Control (n = 10; median age = 69 years); recruitment rate of 58.6%. The study was interrupted by the COVID-19 pandemic. Adherence to the prescribed intensity of the supervised exercise program was 84.1% (SD 23.1). Self-reported adherence to the home-based exercise program was 88.2% (SD 21) and to the nutritional supplement, 93.2% (SD 14.2). Adherence to patients' preoperative assessment was 82% and 88% in Prehab and Control, respectively. The mean adjusted difference in 4-week preoperative 6MWT between groups was 37.7 m (95% CI, -6.1 to 81.4), p = 0.089. There were no differences in HRQoL between groups. CONCLUSION: Within a preoperative timeframe, it was feasible to deliver this novel multimodal prehabilitation intervention in lung cancer patients awaiting surgery.

Teleprehabilitation during COVID-19 pandemic: the essentials of "what" and "how".

In view of the COVID-19 pandemic and recent global events, the healthcare system and its services have been negatively affected, contributing towards extensive surgical backlogs. Oncological surgical candidates have been the most impacted by these changes and recommended self-isolation practices, which could result in emotional distress, sedentary behavior, and poor lifestyle habits. Preoperative supportive intervention, prehabilitation, has been proven to improve patients' functional status and clinical trajectories. Presently, there is a critical need for prehabilitation to optimize patient health, as they experience extended wait times. However, in-hospital delivery may not be an ideal approach due to public health and safety measures. Telehealth is a field of research and practice, which has grown and evolved significantly in the last two decades, allowing for the remote delivery of health services. Therefore, the current commentary addresses the different modalities of telehealth delivery in perspective of their known feasibility and potential application in prehabilitation.