Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503185
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-05-28
Brief Title:
The PREPARE for Cancer Surgery Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multimodal PReoperative Exercise to Decrease PostoperAtive Disability Cancer RecurrencE and Mortality in Older People With Frailty
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 49 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 HR07 assuming a median time to event of 25 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
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 49 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 HR07 assuming a median time to event of 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None