The PREPARE for Cancer Surgery Study

NCT ID: NCT06503185

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 413 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-13
• Study Completion Date: 2030-05-31

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.

Conditions

Surgery-Complications; Cancer; Frailty; Disability Physical

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Prehabilitation

Intervention Type: BEHAVIORAL

The intervention is a home-based, multimodal exercise prehabilitation program. Exercise is 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.

Control

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.

No interventions assigned to this group

Interventions

Prehabilitation

The intervention is a home-based, multimodal exercise prehabilitation program. Exercise is 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel I McIsaac, MD,MPH,FRCPC

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital Research Institute

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

20240283-01H

Identifier Type: -

Identifier Source: org_study_id