A Pragmatic Non-Randomized Trial of Prehabilitation Prior to Cancer Surgery: Study Protocol and COVID-19-Related Adaptations

Frontiers in Oncology

Karen A. Ng¹  Alaa El Danab²  Daniel Sellers³  Hance Clarke³  Stuart McCluskey³  Keyvan Karkouti³  Ian M. Randall³  Darren Au³  Daniel Santa Mina³  Karim Ladha⁴  Brian H. Cuthbertson⁵  Anand Govindarajan⁶  Andrew G. Matthew⁷  Fayez Quereshy⁷  Gail Darling⁷  Shabbir M. H. Alibhai⁸ 

[1] 0Department of Geriatrics, Sinai Health System, Toronto, ON, Canada;Clinical Nutrition, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada;Department of Anesthesia and Pain Management, University Health Network, Toronto, ON, Canada;Department of Anesthesia, St. Michael’s Hospital, Toronto, ON, Canada;Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, ON, Canada;Department of Surgery, Sinai Health System, Toronto, ON, Canada;Department of Surgical Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada;Division of General Internal Medicine and Geriatrics, University Health Network, Toronto, ON, Canada;Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada;Faculty of Medicine, University of Toronto, Toronto, ON, Canada;

关键词: prehabilitation;    cancer;    pragmatic trial;    cancer surgery;    health quality;    implementation science;   

DOI  :  10.3389/fonc.2021.629207

来源: DOAJ

【 摘 要 】

BackgroundExperimental data highlight the potential benefits and health system cost savings related to surgical prehabilitation; however, adequately powered randomized controlled trial (RCT) data remain nascent. Emerging prehabilitation services may be informed by early RCT data but can be limited in informing real-world program development. Pragmatic trials emphasize external validity and generalizability to understand and advise intervention development and implementation in clinical settings. This paper presents the methodology of a pragmatic prehabilitation trial to complement emerging phase III clinical trials and inform implementation strategies.MethodsThis is a pilot pragmatic clinical trial conducted in a large academic hospital in Toronto, Ontario, Canada to assess feasibility of clinical implementation and derive estimates of effectiveness. Feasibility data include program referral rates, enrolment and attrition, intervention adherence and safety, participant satisfaction, and barriers and facilitators to programming. The study aims to receive 150 eligible referrals for adult, English-speaking, preoperative oncology patients with an identified indication for prehabilitation (e.g., frailty, deconditioning, malnutrition, psychological distress). Study participants undergo a baseline assessment and shared-decision making regarding the intervention setting: either facility-based prehabilitation or home-based prehabilitation. In both scenarios, participants receive an individualized exercise prescription, stress-reduction psychological support, nutrition counseling, and protein supplementation, and if appropriate, smoking cessation program referrals. Secondary objectives include estimating intervention effects at the week prior to surgery and 30 and 90 days postoperatively. Outcomes include surgical complications, postoperative length of stay, mortality, hospital readmissions, physical fitness, psychological well-being, and quality of life. Data from participants who decline the intervention but consent for research-related access to health records will serve as comparators. The COVID-19 pandemic required the introduction of a ‘virtual program’ using only telephone or internet-based communication for screening, assessments, or intervention was introduced.ConclusionThis pragmatic trial will provide evidence on the feasibility and viability of prehabilitation services delivered under usual clinical conditions. Study amendments due to the COVID-19 pandemic are presented as strategies to maintain prehabilitation research and services to potentially mitigate the consequences of extended surgery wait times.

【 授权许可】

Unknown