Clinical trial NCT06503185: The PREPARE for Cancer Surgery Study
Official title: Multimodal PReoperative Exercise to Decrease PostoperAtive Disability, Cancer RecurrencE and Mortality in Older People With Frailty
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Surgery-Complications
Cancer
Frailty
Disability Physical
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 413
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Older adults with frailty having cancer surgery

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.

Eligibility criteria: 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

Primary outcomes:
measure: Event free survival (EFS) in the 5 years after surgery
timeFrame: 5 years
Secondary outcomes:
measure: Patient-reported disability trajectory in the year after surgery measured using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
timeFrame: 1 year after surgery
measure: Return to intended oncologic treatment (RIOT)
timeFrame: at 4 months after surgery
Other outcomes:
measure: Function- Katz Index of Activities of Daily Living
timeFrame: Day 3, 5, 7 and up to 30 days after surgery
measure: Function- Falls
timeFrame: Day 3, 5, 7 and up to 30 days after surgery
measure: Function- Health-related quality of life
timeFrame: Day 3, 5, 7 and up to 30 days after surgery
measure: Complications
timeFrame: Day 3, 5, 7 and up to 30 days after surgery
measure: Health system- Discharge disposition
timeFrame: 1 year
measure: Health system- Readmissions
timeFrame: 1 year
measure: Health system- Long-term care admissions
timeFrame: 1 year
measure: Health system- Emergency department visits
timeFrame: 1 year
measure: Health system- Healthcare system costs
timeFrame: 1 year
measure: Overall survival
timeFrame: 5 years
measure: Participant feedback
timeFrame: Participants are asked to reflect on the program during a call the day before surgery
measure: Safety (Adverse Events)
timeFrame: Pre-surgery
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital Research Institute
name: Daniel I McIsaac, MD,MPH,FRCPC
role: PRINCIPAL_INVESTIGATOR
References: