The PREPARE for Cancer Surgery Study
NCT Number: NCT06503185
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Surgery-Complications|Cancer|Frailty|Disability Physical
Interventions: BEHAVIORAL: Prehabilitation
Sponsor: Ottawa Hospital Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 413
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-13
Completion Date: 2030-05-31
Locations: The Ottawa Hospital, Ottawa, Ontario, Canada

Summary:
Our team recently closed recruitment for the PREPARE Trial: PReoperative Exercise to decrease PostoperAtive complication Rates and disability scorEs. The trial enrolled a total of 850 participants; 523 of which were recruited locally at The Ottawa Hospital (TOH). Of the 523 enrolled at TOH, 413 patient participants were on the pathway for cancer surgery and have either completed the study or are in follow-up (participants who withdrew from the full study have been excluded from the sample size in this sub-study proposal). Unexpectedly, almost 80% of the PREPARE Trial sample was linked to cancer surgery - most likely because cancer surgeries were prioritized during the pandemic. This provides us with the opportunity, and perhaps the responsibility, to specifically assess oncology related outcomes. We propose to follow this TOH sub-group of oncology patients for five years following their surgical date, by retrospectively collecting clinical and health administrative data at annual timepoints.

Primary Outcome Measures: Event free survival (EFS) in the 5 years after surgery, Event free survival (similar to disease free survival, but more appropriate for scenarios where surgery is planned after randomization, but could be precluded by disease progression) will be defined using US Food and Drug Administration (FDA) criteria as: the time after randomization to the earliest of a) progression of disease that precludes surgery, local or distant recurrence, or death due to any cause., 5 years
Secondary Outcome Measures: Patient-reported disability trajectory in the year after surgery measured using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS), WHODAS is a patient-reported disability scale that assesses limitations in six major life domains (i.e., cognition, mobility, self-care, social interaction, life activities, participation in society). Scores will be normalized to a 100-point scale where higher scores indicate higher disability, with a difference of 5-points representing a minimally important difference after surgery., 1 year after surgery|Return to intended oncologic treatment (RIOT), This outcome is measured as the time from surgery to initiation (or re-initiation) or chemo-, radiation- or immuno-therapy after surgery, and will be retrospectively censored at 4-months after surgery to reflect variable recommended timeframes for initiation of adjuvant therapy across cancer types, at 4 months after surgery
Other Outcome Measures: Function- Katz Index of Activities of Daily Living, The Katz Index measures function in activities of daily living (ADL). The ADLs examined are bathing, dressing, toileting, transferring, continence and feeding. If a person is able to perform the ADL independently, they receive 1 point for that activity. If a person is dependent on others to perform the ADL, they receive 0 points for that activity. A score of 6 is high, meaning the person is independent whereas a score of 0 is low, indicating that the person is very dependent., Day 3, 5, 7 and up to 30 days after surgery|Function- Falls, Falls will be documented as a way of assessing function., Day 3, 5, 7 and up to 30 days after surgery|Function- Health-related quality of life, EQ5D5L will be used to measure health-related quality of life at baseline and in-hospital after surgery. Participants are asked to select one answer under each domain (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Responses range from having no problems with a particular domain to being unable to engage in that particular domain. Participants are asked to identify on a scale of 0-100 how good or bad their health is on that given day (0 being worst health they can imagine, 100 being best health they can imagine)., Day 3, 5, 7 and up to 30 days after surgery|Complications, Complications will be collected using the Post-Operative Morbidity Survey, a well-validated prospective instrument for identifying in-hospital complications in key organ systems based on objective criteria, Day 3, 5, 7 and up to 30 days after surgery|Health system- Discharge disposition, Discharge disposition will be prospectively collected. Assess where the participant will be discharged to once out of hospital., 1 year|Health system- Readmissions, Readmissions will be prospectively collected. Linkage to administrative data will allow for collection of readmissions in the year after surgery., 1 year|Health system- Long-term care admissions, Linkage to administrative data will allow for collection of subsequent long-term care admissions in the year after surgery., 1 year|Health system- Emergency department visits, Emergency department visits since hospital discharge will be captured in the year after surgery, 1 year|Health system- Healthcare system costs, Linkage to administrative data will allow for collection of health system costs in the year after surgery., 1 year|Overall survival, Survival will be confirmed through linkage to health administrative data, 5 years|Participant feedback, A theoretical domains framework participant survey will identify barriers and facilitators to participation in the exercise group. Responses are on a five-point likert scale ranging from "strongly disagree" to "strongly agree", or "never" to "always" depending on the question asked, Participants are asked to reflect on the program during a call the day before surgery|Safety (Adverse Events), Falls, cardiac or respiratory events and unplanned healthcare encounters will be collected during the exercise treatment period. Expert adjudication will determine whether they were study-attributable, Pre-surgery