A review of patient recruitment in randomised controlled trials of preoperative exercise.

BACKGROUND: Randomised controlled trials (RCTs) are considered the gold standard design to determine the effectiveness of an intervention, as the only method of decreasing section bias and minimising random error. However, participant recruitment to randomised controlled trials is a major challenge, with many trials failing to recruit the targeted sample size accordingly to the planned protocol. Thus, the aim of this review is to detail the recruitment challenges of preoperative exercise clinical trials. METHODS: A comprehensive search was performed on MEDLINE, Embase, The Cochrane Library, CINAHL, AMED and PsycINFO from inception to July 2021. Randomised controlled trials investigating the effectiveness of preoperative exercise on postoperative complication and/or length of hospital stay in adult cancer patients were included. Main outcomes included recruitment rate, retention rate, number of days needed to screen and recruit one patient and trial recruitment duration. Descriptive statistics were used to summarise outcomes of interest. RESULTS: A total of 27 trials were identified, including 3656 patients screened (N = 21) and 1414 randomised (median recruitment rate (interquartile range) = 53.6% (25.2%-67.6%), N = 21). The sample size of the included trials ranged from 19 to 270 (median = 48.0; interquartile range = 40.0-85.0) and the duration of trial recruitment ranged from 3 to 50 months (median = 19.0 months; interquartile range = 10.5-34.0). Overall, a median of 3.6 days was needed to screen one patient, whereas 13.7 days were needed to randomise one participant. Over the trials duration, the median dropout rate was 7.9%. Variations in recruitment outcomes were observed across trials of different cancer types but were not statistically significant. CONCLUSION: The recruitment of participants to preoperative exercise randomised controlled trials is challenging, but patient retention appears to be less of a problem. Future trials investigating the effectiveness of a preoperative exercise programme following cancer surgery should consider the time taken to recruit patients. Strategies associated with improved recruitment should be investigated in future studies.

Consumer Perspectives on the Adoption of a Prehabilitation Multimodal Online Program for Patients Undergoing Cancer Surgery.

This study aimed to explore patients' perspectives on the adoption of a prehabilitation multimodal online program. Patients recovering from gastrointestinal cancer surgery at a tertiary hospital between October 2021 and November 2022 were invited to participate. An e-Health program including intensity exercises, nutrition and psychological counselling was used. Patients were instructed to navigate the e-Health program over 24 h using an iPad and then complete the study survey. Patients' characteristics, use of technology, views and minimal expected outcomes from a preoperative online program were collected. Of the 30 patients included, most were female, most reported confidence in the use of technology, most considered the online program safe and most agreed it would be beneficial for their health. "Poor preoperative health" and "lack of motivation and encouragement" were identified as the main barriers to the uptake of a preoperative online program, while program 'simplicity' and perceived 'benefits' were the main facilitators. Significant improvement in postoperative outcomes is perceived to influence patients' willingness to participate in a preoperative multimodal e-Health program. Gastrointestinal cancer patients perceived the adoption of a preoperative multimodal e-Health application as safe to be performed at home and of potential benefit to their health. A range of patient's characteristics, barriers and facilitators to the uptake of an online program were identified. These should be considered in future preoperative multimodal online programs to enhance patient experience, adherence and efficacy. The safety and efficacy of the online prehabilitation program will need to be determined in a larger randomized controlled trial.

Research Priorities in Prehabilitation for Patients Undergoing Cancer Surgery: An International Delphi Study.

BACKGROUND: Recently, the number of prehabilitation trials has increased significantly. The identification of key research priorities is vital in guiding future research directions. Thus, the aim of this collaborative study was to define key research priorities in prehabilitation for patients undergoing cancer surgery. METHODS: The Delphi methodology was implemented over three rounds of surveys distributed to prehabilitation experts from across multiple specialties, tumour streams and countries via a secure online platform. In the first round, participants were asked to provide baseline demographics and to identify five top prehabilitation research priorities. In successive rounds, participants were asked to rank research priorities on a 5-point Likert scale. Consensus was considered if > 70% of participants indicated agreement on each research priority. RESULTS: A total of 165 prehabilitation experts participated, including medical doctors, physiotherapists, dieticians, nurses, and academics across four continents. The first round identified 446 research priorities, collated within 75 unique research questions. Over two successive rounds, a list of 10 research priorities reached international consensus of importance. These included the efficacy of prehabilitation on varied postoperative outcomes, benefit to specific patient groups, ideal programme composition, cost efficacy, enhancing compliance and adherence, effect during neoadjuvant therapies, and modes of delivery. CONCLUSIONS: This collaborative international study identified the top 10 research priorities in prehabilitation for patients undergoing cancer surgery. The identified priorities inform research strategies, provide future directions for prehabilitation research, support resource allocation and enhance the prehabilitation evidence base in cancer patients undergoing surgery.

Feasibility, Reliability, and Safety of Remote Five Times Sit to Stand Test in Patients with Gastrointestinal Cancer.

Background: To determine the feasibility, reliability, and safety of the remote five times sit to stand test (5STS) test in patients with gastrointestinal cancer. Methods: Consecutive adult patients undergoing surgical treatment for lower gastrointestinal cancer at a major referral hospital in Sydney between July and November 2022 were included. Participants completed the 5STS test both face-to-face and remotely, with the order randomised. Outcomes included measures of feasibility, reliability, and safety. Results: Of fifty-five patients identified, seventeen (30.9%) were not interested, one (1.8%) had no internet coverage, and thirty-seven (67.3%) consented and completed both 5STS tests. The mean (SD) time taken to complete the face-to-face and remote 5STS tests was 9.1 (2.4) and 9.5 (2.3) seconds, respectively. Remote collection by telehealth was feasible, with only two participants (5.4%) having connectivity issues at the start of the remote assessment, but not interfering with the tests. The remote 5STS test showed excellent reliability (ICC = 0.957), with limits of agreement within acceptable ranges and no significant systematic errors observed. No adverse events were observed within either test environment. Conclusions: Remote 5STS for the assessment of functional lower extremity strength in gastrointestinal cancer patients is feasible, reliable, and safe, and can be used in clinical and research settings.

Functional Outcomes Following Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy: A Prospective Cohort Study.

BACKGROUND: Pre-operative physical status and its association with post-operative surgical outcomes is poorly understood in patients with peritoneal malignancy who undergo cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC). The aims of this study were to determine the pre-operative physical function in patients having CRS-HIPEC and investigate the association between physical function and post-operative outcomes. PATIENTS AND METHODS: Patients undergoing CRS-HIPEC between 2017 and 2021 were recruited at a single quaternary referral hospital in Sydney, Australia. The primary physical function measures were the 6-min walk test (6MWT) and the five-times sit to stand test (5STS). Data were collected pre-operatively and at post-operative day 10, and were analysed according to pre-operative patient characteristics and post-operative outcomes such as length of hospital stay (LOS) and complications. RESULTS: The cohort of patients that participated in functional assessments consisted of 234 patients, with a median age of 56 years. Patients having CRS-HIPEC performed worse on the 6MWT pre-operatively compared with the general Australian population (p < 0.001). Post-operatively, these patients experienced a further deterioration in 6MWT and 5STS performance and the degree of the post-operative decline in function was associated with post-operative morbidity. A higher level of pre-operative physical function was associated with shorter LOS and minor post-operative complications. CONCLUSIONS: Patients who have undergone CRS-HIPEC were functionally impaired pre-operatively compared with the general population and experience a further deterioration of physical function post-operatively. A higher level of pre-operative physical function is associated with minor post-operative morbidity, which is highly relevant for pre-operative optimisation of patients with cancer.

PRehabIlitatiOn with pReoperatIve exercise and educaTion for patients undergoing major abdominal cancer surgerY: protocol for a multicentre randomised controlled TRIAL (PRIORITY TRIAL).

BACKGROUND: Radical surgery is the mainstream treatment for patients presenting with advanced primary or recurrent gastrointestinal cancers; however, the rate of postoperative complications is exceptionally high. The current evidence suggests that improving patients' fitness during the preoperative period may enhance postoperative recovery. Thus, the primary aim of this study is to establish the effectiveness of prehabilitation with a progressive, individualised, preoperative exercise and education program compared to usual care alone in reducing the proportion of patients with postoperative in-hospital complications. The secondary aims are to investigate the effectiveness of the preoperative intervention on reducing the length of intensive care unit and hospital stay, improving quality of life and morbidity, and reducing costs. METHODS: This is a multi-centre, assessor-blinded, pragmatic, comparative, randomised controlled trial. A total of 172 patients undergoing pelvic exenteration, cytoreductive surgery, oesophagectomy, hepatectomy, gastrectomy or pancreatectomy will be recruited. Participants will be randomly allocated to prehabilitation with a preoperative exercise and education program (intervention group), delivered over 4 to 8 weeks before surgery by community physiotherapists/exercise physiologists, or usual care alone (control group). The intervention will comprise 12 to 24 individualised, progressive exercise sessions (including aerobic/anaerobic, resistance, and respiratory exercises), recommendations of home exercises (16 to 32 sessions), and daily incidental physical activity advice. Outcome measures will be collected at baseline, the week prior to surgery, during the hospital stay, and on the day of discharge from hospital, and 1 month and 1 months postoperatively. The primary outcome will be the development of in-hospital complications. Secondary outcomes include the length of intensive care unit and hospital stay, quality of life, postoperative morbidity and costs. DISCUSSION: The successful completion of this trial will provide robust and high-quality evidence on the efficacy of a preoperative community- and home-based exercise and education intervention on important postoperative outcomes of patients undergoing major gastrointestinal cancer surgery. TRIAL REGISTRATION: This trial was registered prospectively with the Australian New Zealand Clinical Trials Registry ( ACTRN12621000617864 ) on 24th May 2021.

Preoperative Cardiopulmonary Exercise Test Associated with Postoperative Outcomes in Patients Undergoing Cancer Surgery: A Systematic Review and Meta-Analyses.

BACKGROUNDS: There is mixed evidence on the value of preoperative cardiorespiratory exercise test (CPET) to predict postoperative outcomes in patients undergoing a cancer surgical procedure. The purpose of this review was to investigate the association between preoperative CPET variables and postoperative complications, length of hospital stay, and quality of life in patients undergoing cancer surgery. METHODS: A search was conducted on MEDLINE, Embase, AMED, and Web of science from inception to April 2020. Cohort studies investigating the association between preoperative CPET variables, including peak oxygen uptake (peak VO2), anaerobic threshold (AT), or ventilatory equivalent for carbon dioxide (VE/VCO2), and postoperative outcomes (complications, length of stay, and quality of life) were included. Risk of bias was assessed using the QUIPS tool. A random-effect model meta-analysis was performed whenever possible. RESULTS: Fifty-two unique studies, including 10,030 patients were included. Overall, most studies were rated as having low risk of bias. Higher preoperative peak VO2 was associated with absence of postoperative complications (mean difference [MD]: 2.28; 95% confidence interval [CI]: 1.26-3.29) and no pulmonary complication (MD: 1.47; 95% CI: 0.49-2.45). Preoperative AT and VE/VCO2 also demonstrated some positive trends. None of the included studies reported a negative trend. CONCLUSIONS: This systematic review and meta-analysis demonstrated a significant association between superior preoperative CPET values, especially peak VO2, and better postoperative outcomes. The assessment of preoperative functional capacity in patients undergoing cancer surgery has the potential to facilitate treatment decision making.