RESUMEN
Background: Surgical resection remains the primary curative treatment for intra-cavity cancer. Low physical fitness and psychological factors such as depression are predictive of post-operative morbidity, mortality and length of hospital stay. Prolonged post-operative morbidity is associated with persistently elevated risk of premature death. We aim to investigate whether a structured, responsive exercise training programme, a psychological support programme or combined exercise and psychological support, delivered between treatment decision and major intra-cavity surgery for cancer, can reduce length of hospital stay, compared with standard care. Methods: WesFit is a pragmatic , 2x2 factorial-design, multi-centre, randomised-controlled trial, with planned recruitment of N=1560. Participants will be randomised to one of four groups. Group 1 (control) will receive usual pre-operative care, Group 2 (exercise) patients will undergo 2/3 aerobic, high-intensity interval training sessions per week supervised by personal trainers. Group 3 (psychological support) patients are offered 1 session per week at a local cancer support centre. Group 4 will receive both exercise and psychological support. All patients undergo baseline and pre-operative cardiopulmonary exercise testing, complete self-report questionnaires and will be followed up at 30 days, 12 weeks and 12 months post-operatively. Primary outcome is post-operative length-of-stay. Secondary outcomes include disability-adjusted survival at 1-year postoperatively, post-operative morbidity, and health-related quality of life. Exploratory investigations include objectively measured changes in physical fitness assessed by cardiopulmonary exercise test, disease-free and overall mortality at 1-year postoperatively, longer-term physical activity behaviour change, pre-operative radiological tumour regression, pathological tumour regression, pre and post-operative body composition analysis, health economics analysis and nutritional characterisation and its relationship to post-operative outcome. Conclusions: The WesFit trial will be the first randomised controlled study investigating whether an exercise training programme +/- psychological intervention results in improvements in clinical and patient reported outcomes in patients undergoing major inter-cavity resection of cancer. ClinicalTrials.gov registration: NCT03509428 (26/04/2018).
Asunto(s)
Neoplasias , Ejercicio Preoperatorio , Humanos , Estudios Multicéntricos como Asunto , Neoplasias/cirugía , Cuidados Preoperatorios/métodos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de InvestigaciónRESUMEN
BACKGROUND: The NHS Bowel Cancer Screening Programme (BCSP) in England does not involve general practitioners (GPs). Uptake is â¼58%. The Practice Endorsed Additional Reminder Letter (PEARL) study piloted a GP-endorsed reminder letter. METHODS: General practices in Wessex with uptake <55% (prevalent invitations) were invited to participate. Subjects who had been invited for screening, sent a standard 28-day BCSP reminder letter but had not returned a test kit within 30 days of the standard reminder were sent a second reminder letter bearing the GP's letterhead and signature. Uptake was compared between PEARL and non-PEARL practices by standardised uptake ratio (standardised for prior prevalent uptake and other confounders). In addition, 25 non-PEARL practices were matched with PEARL practices for prior prevalent uptake and number of invitees. RESULTS: Twenty-five practices agreed to participate. A total of 3149 GP-endorsed reminders were sent. Uptake in the PEARL practices was 54% compared with 51% in the matched-control practices. The adjusted RR for uptake was 1.08 (95% CI: 1.05, 1.11, P<0.001) for all invitees and 2.18 (1.79, 2.66, P<0.001) for invitees who had not returned a kit following the standard reminder. CONCLUSIONS: The GP-endorsed reminder was associated with significantly increased uptake among subjects not responding to the standard reminder letter.