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

Abstract

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.

The Role and Effect of Multimodal Prehabilitation Before Major Abdominal Surgery: A Systemic Review and Meta‐Analysis

“…The benefits of multimodal prehabilitation continue to be explored via large trials [68], and programmes are increasingly being incorporated into standard care [69]. As more studies are conducted, it is vital to examine the target populations and the outcomes of these programmes.…”

Developing a virtual assessment protocol for the AMPLIFI Randomized Controlled Trial due to COVID-19: From assessing participants' preference to preparing the team

“…Our study found that utilizing trained research assessment staff for anthropometric and physical performance testing, along with the Zoom application, camera and internet connection, made these assessments feasible and safe. This is an important contribution to the literature and presents a different approach from other researchers who adapted in person research during COVID-19 in cancer survivors and other populations [2,[5][6][7]. In one study, investigators chose to forgo collecting objective outcomes (e.g., body composition, 6-min walk test) in individuals with cancer and focused only on outcomes that they could collect remotely (e.g., questionnaire data and data from electronic medical records) [7].…”

“…This is an important contribution to the literature and presents a different approach from other researchers who adapted in person research during COVID-19 in cancer survivors and other populations [2,[5][6][7]. In one study, investigators chose to forgo collecting objective outcomes (e.g., body composition, 6-min walk test) in individuals with cancer and focused only on outcomes that they could collect remotely (e.g., questionnaire data and data from electronic medical records) [7]. Importantly, that study was conducted among cancer patients prior to their cancer surgery: investigators may have deemed that it was safest to omit in-person functional assessments because participants may have been most vulnerable at this point of their cancer journey.…”

“…Survey responders were recruited among 92 AMPLIFI potential research participants, i.e., survivors who expressed their intent to participate in the AMPLIFI RCT before research activities stopped due to COVID-19. The AMPLIFI study targets cancer survivors who meet these eligibility criteria: (1) age 50 years old or older; (2) 1 year post from a diagnosis of multiple myeloma, or localized and regional cancers of the breast, colorectum, endometrium, prostate, or localized cancers of the ovary or kidney; (3) community dwelling and from areas with wireless coverage; (4) English-speaking/reading; (5) education of 8th grade education level or higher; (6) without physical limitations that preclude unsupervised physical activity, such as recent heart attack, dementia, blindness; (7) with some evidence of functional limitation (as assessed with the Medical Outcomes Study Short Form 36 [SF-36]); ( 8) BMI of at least 25 kg/m 2 but less than 50 kg/m 2 ; (9) <150 min of self-reported weekly moderate-to-vigorous level physical activity); and (10) intake of <2.5 daily servings of fruits and vegetables. Recruitment, screening, and enrollment for AMPLIFI was conducted by the Recruitment and Retention Shared Facility of the O'Neal Comprehensive Cancer Center at UAB.…”

Recovery of surgery in the elderly (ROSE) program: The efficacy of a multi‐modal prehabilitation program implemented in frail and pre‐frail elderly undergoing major abdominal surgery

“…11 Hence, in recent years, prehabilitation evidence has grown in patients who are frail, higher risk and/or vulnerable to perioperative complications who are likely to benefit most from prehabilitation. 12 With a paucity of evidence conducted on the higher risk pre-frail and frail population planned for elective major abdominal surgery, there is a need to investigate the impact of a multimodal prehabilitation supervised program in mitigating postoperative functional decline when compared to standard care.…”