Open surgery is the standard of care for suspicious complex adnexal pelvic masses, usually combined with intraoperative frozen section analysis. These lesions may be benign, borderline, or cancerous and are often partly solid and partly cystic in nature. Risk stratification using imaging and tumour markers may be performed preoperatively. To date, no randomised controlled trial (RCT) has compared robotic minimally invasive surgery with open surgery, and existing guidelines primarily focus on the subset with confirmed cancer. This is a single-centre feasibility study (pilot RCT) conducted at the Royal Surrey NHS Foundation Trust in the UK. The trial aims to recruit patients with isolated complex adnexal lesions suspicious for cancer and measuring ≤ 8 cm. Participants are randomised in a 2:1 ratio to either the robotic surgery (study arm) or standard open laparotomy. Intraoperative frozen section analysis guides the extent of surgery in both arms, with no blinding to participants or surgeons. The primary outcomes are recruitment rate, acceptability of randomisation, and questionnaire response rate at predefined assessment time points. Secondary outcomes include conversion from robotic to open surgery, cyst rupture rate, surgical and perioperative morbidity, patient-reported outcomes, and cost analysis. Recruitment will take place over 24 months, with a 6-week follow-up period and a target sample size of 25 participants. Progression to a definitive trial will be based on predefined feasibility criteria, including a recruitment rate of > 60
Acute leukemia is a hematologic malignancy characterized by anemia and thrombocytopenia, leading to a high risk of bleeding complications. Patients with acute leukemia frequently require blood transfusions, particularly during chemotherapy. Current transfusion practice typically maintains hemoglobin concentrations at ≥ 7–8 g/dL; however, a more liberal transfusion strategy aiming for near-normal hemoglobin levels may improve hemostasis by preserving endothelial integrity, improving coagulation and fibrinolysis, and reducing inflammation. This pilot trial will primarily determine the feasibility of conducting a larger randomized trial and will secondarily explore the biological effects of a liberal transfusion strategy on these endpoints. This single-center, pilot randomized clinical trial will recruit 60 participants from an academic hospital in Canada. Participants will be randomized to receive blood transfusions targeting either the standard hemoglobin threshold (7–8 g/dL) or a higher threshold (11 g/dL) at the start of, or within 5 days of initiating, induction chemotherapy. Patients will be followed during their hospital admission for up to 30 days. The primary outcomes are feasibility measures: recruitment (consent and screen-failure rates) and protocol adherence (adherence to the assigned transfusion strategy and to the study schedule). Secondary outcomes include the estimated effect of the transfusion strategy on prespecified biomarkers of endothelial integrity (von Willebrand factor antigen and microalbuminuria-to-creatinine ratio), inflammation (C-reactive protein), and coagulation/fibrinolysis (fibrinogen activity), as well as blood product administration, bleeding events, and quality of life. This pilot trial will provide feasibility and biomarker data to inform the design of a larger trial evaluating the effect of a liberal transfusion strategy on bleeding outcomes in acute leukemia. This research program will enhance supportive care for patients and address an evidence gap in transfusion guidelines for this high-risk population. Registered on Clinicaltrials.gov: NCT06947044. URL: https://clinicaltrials.gov/study/NCT06947044. Date of registration: 19-04-2025.
Chronic non-cancer pain disproportionately impacts Black adults in the USA. Primary care clinicians (PCCs) receive limited training in empathy and perspective-taking, likely contributing to treatment disparities. We assessed the feasibility and acceptability of a novel virtual training, featuring AI-generated patient videos, designed to improve PCCs' perspective-taking skills and reduce treatment disparities. We recruited PCCs from two health systems in the Midwestern US. The training included a didactic module on pain disparities and perspective-taking, delivered by an AI-generated Black "peer" clinician, along with videos of photorealistic digital Black patients sharing their experiences living with chronic pain. PCCs practiced perspective-taking via a typed-response interface. Feasibility was assessed using time-on-task and completion rates; acceptability via system usability scores and written feedback. Using electronic health records data, we conducted an exploratory patient-level analysis comparing pain medication prescribing (three months before versus after the intervention date) for Black versus non-Black patients of intervention PCCs against a control group of 19 high-prescribing PCCs from the same health systems who did not complete the training. Logistic regression models estimated overall pain prescribing changes and initiation of new medications across nine drug classes. Fifteen PCCs (5 from health system #1; 10 from health system #2) completed the training between December 2024 and February 2025. The training proved feasible and acceptable: average completion time was approximately 6 min, and 73.3
Abstract Background Patients undergoing surgery due to peritoneal metastases (PM) are at high risk of postoperative pulmonary complications (PPCs). While several studies have provided promising results regarding the positive effects of preoperative inspiratory muscle training (IMT) regarding length of hospital stay and PPCs after other types of major abdominal surgery, its feasibility in the preoperative management of patients with PM is still unclear. The aim of the study was to evaluate the feasibility of preoperative IMT for patients scheduled for cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). Methods A single-blinded randomized controlled feasibility study was conducted in Uppsala, Sweden, between 2016 and 2020. Inclusion criteria were age ≥ 18 years, surgery scheduled ≥ 2 weeks after inclusion, and proficiency in Swedish. Patients were randomized 1:1 to either IMT or positive expiratory pressure (PEP). Feasibility was evaluated using two domains: process feasibility (recruitment, intervention adherence, and patient acceptability) and scientific feasibility (ability to perform pre- and postoperative respiratory muscle and lung function assessments, reproducibility of assessments, and adverse events). Preliminary treatment effects and incidence of postoperative pulmonary complications (PPCs) were also evaluated. Results Thirty participants were enrolled, with a recruitment rate of 11%. The median training period was 24.5 days, with adherence of 77% in the intervention group and 98% in the control group. Acceptability was high, with 87% rating the training program ≥ 5 on a scale of 1–10. Two participants withdrew due to discomfort at the postoperative assessments, and the reproducibility of assessments was 57–100%. One IMT participant withdrew due to a dry cough. The intervention group showed a larger increase in maximal inspiratory pressure (MIP) from baseline to follow-up and faster recovery of vital capacity (VC) than controls. PPCs were more frequent in the control group. Conclusions Preoperative IMT was acceptable to patients and safe, but recruitment and attrition were identified as obstacles to address in a future full-scale RCT. Trial registration NCT05665257 . Registered 23 December 2022—retrospectively registered.
Adherence to Canada’s 24-Hour Movement Guidelines (24HMG) is low among post-secondary students, a situation worsened by the COVID-19 pandemic. Mobile health (mHealth) offers scalable avenues for behaviour change, yet its feasibility in this population and context is untested. To assess the feasibility, acceptability, and potential impact of a theory-driven mHealth intervention designed to promote adherence to the 24HMG behaviours (i.e. moderate-to-vigorous intensity physical activity [MVPA], sedentary behaviour, and sleep). A multicentre, single-arm proof-of-concept study was conducted in Fall 2021 at Queen’s University (Ontario) and the University of British Columbia. Eligible first-year students who self-reported <150 min/week of MVPA and low-to-average mental well-being were enrolled in a 6-week in-app content journey (12 short articles, four weekly push notifications) plus campus-specific resource packs and received a Fitbit Inspire 2 to track movement behaviours. Feasibility metrics (i.e. recruitment, retention, device adherence), acceptability (i.e. in-app engagement, satisfaction surveys, interviews), and preliminary outcomes (i.e. movement behaviours; 24HMG awareness and knowledge; 24HMG capability, opportunity, motivation) were analysed using descriptive statistics, multilevel modelling, and inductive content analysis. Of the 303 students screened, 77 were eligible for participation and 68 enrolled in the study (Mage = 18.1 ± 0.3 years; 72
