Clinical trial · Observational
The PREPARE for Cancer Surgery Study
Multimodal PReoperative Exercise to Decrease PostoperAtive Disability, Cancer RecurrencE and Mortality in Older People With Frailty
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Disability Physical | — | UNRESOLVED | — |
| Frailty | — | UNRESOLVED | — |
| Surgery-Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Prehabilitation
- description
- The intervention is a home-based, multimodal exercise prehabilitation program. Exercise was prescribed in one-hour sessions, performed a minimum of three times per week for three weeks, consisting of: 1) strength training, 2) aerobic exercise and 3) flexibility. The intervention group will receive weekly phone calls to gauge adherence, suggest modifications, provide support and track any adverse events.
- interventionNames
- Behavioral: Prehabilitation
- label
- Control
- description
- The control group received the World Health Organization recommendations for physical activity for people greater or equal to the age of 65 years old pamphlet, as well as a guide to healthy eating for older adults.
Primary outcomes (1)
- measure
- Event free survival (EFS) in the 5 years after surgery
- timeFrame
- 5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged ≥60 years * Scheduled, or on the pathway, for elective surgery eLOS ≥2 days * Expected surgery date between 3 and 12 weeks from enrollment * Clinical Frailty Scale (CFS) score ≥4/9 Exclusion Criteria: * Inability to speak English or French * Co-morbidity preventing assessment or understanding of questionnaires * Unable to be contacted by telephone * Unwilling to participate in exercise program * Cardiac, neurological or orthopedic procedure * Palliative surgery * Certain cardiovascular conditions
References
Publications (0)
Data not yet available