The PREPARE for Cancer Surgery Study
- Conditions
- Surgery-ComplicationsDisability PhysicalCancerFrailty
- Interventions
- Behavioral: Prehabilitation
- Registration Number
- NCT06503185
- Lead Sponsor
- Ottawa Hospital Research Institute
- Brief 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.
- Detailed Description
Background: Among cancer surgery patients, systematic reviews suggest a 55% relative improvement in cancer free survival after multimodal prehabilitation. Unfortunately, prehabilitation trials have largely excluded individuals living with frailty. Simply put, we urgently require data from multicenter prehabilitation trials testing interventions that: A) support adequate adherence; and B) focus on older people with frailty having cancer surgery.
Research aims:
1. Does participation in home-based, multimodal prehabilitation improve 5-year event free survival among older adults with frailty having cancer surgery?
2. Does participation in home-based, multimodal prehabilitation improve physical recovery as assessed using patient reported disability scores across the first year after surgery among older adults with frailty having cancer surgery?
3. Does participation in home-based, multimodal prehabilitation lead to earlier return to intended oncologic treatment among older adults with frailty having cancer surgery?
Methods:
Design, setting and participants: This is a cancer-specific sub-study of the PREPARE Trial. This will be a retrospective cohort study performed using clinical and health administrative data from the electronic medical record (EPIC). People =\> 60 years old with frailty (Clinical Frailty Scale score of 4/9) and cancer having major elective non-cardiac surgery (vascular, intrathoracic, intraabdominal, pelvic, ENT) with expected length of stay of =\> 2 days will be included.
Intervention: Home-based exercise program with demonstrated efficacy, feasibility and acceptability tailored for people with frailty.
Outcomes and sample size: The primary outcome is event free survival (EFS) in the 5 years after surgery. Secondary outcomes include patient-reported disability trajectory in the year after surgery (WHODAS) and return to intended oncologic treatment (RIOT). Tertiary outcomes include measures of function, complications, survival, and resource use.
Based on our sample size and expected event rate, with 413 patients we will have \>80% power to detect a HR=0.7 assuming a median time to event of 2.5 years in the control group).
Expertise: Our team features multidisciplinary clinical and methodological experts, nationally representative knowledge users and patient representatives.
Expected Outcomes: This study will allow us to understand whether prehabilitation is an intervention that can improve both oncologic and physical outcomes through improved recovery for this growing demographic of vulnerable older adults.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 413
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prehabilitation Prehabilitation 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.
- Primary Outcome Measures
Name Time Method Event free survival (EFS) in the 5 years after surgery 5 years 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.
- Secondary Outcome Measures
Name Time Method Patient-reported disability trajectory in the year after surgery measured using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS) 1 year after surgery 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.
Return to intended oncologic treatment (RIOT) at 4 months after surgery 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
Trial Locations
- Locations (1)
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada