NCT06022666

PATH Program for for Severely Frail or Cognitively Impaired Patients Scheduled for Cancer Surgery.

Application of the Palliative and Therapeutic Harmonization (PATH) Program for Shared-decision Making for Severely Frail or Cognitively Impaired Patients Scheduled for Cancer Surgery: a Randomized Control Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Nova Scotia Health Authority · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, non-blinded randomized control trial taking place at the Queen Elizabeth II hospital (QEII) in Nova Scotia. Patients are eligible if aged 75 and older scheduled for elective cancer surgery (proven cancer or highly suspicious cancer) and screened to have mild or greater frailty (with cognitive impairments) or moderate to greater frailty (with medical/physical conditions). Eligible participants will then be randomized to preoperative standard of care or geriatric assessment through the PATH clinic. Primary outcome will assess time spend at home at 6 months after the surgery.

Detailed description

At Nova Scotia Health Authority (NSHA), geriatric medicine colleagues developed a preoperative palliative and therapeutic harmonization (PATH) clinic with the following objectives: 1. Assess medical conditions, health trajectory, and baseline frailty. 2. Conduct an in-depth discussion with the patient (or their substitute decision maker) to review medical conditions and how frailty stage impacts decision-making about surgery. 3. Co-develop a care plan, including ways to optimize health. The investigators have elaborated a single center randomized cohort trial for patients aged 75 and older, screened as severely frail or cognitively impaired scheduled for curative or palliative-intent surgery for bronchopulmonary, oropharyngeal, orthopaedic, gynaecological, breast, genitourinary or gastrointestinal cancers (proven or clinically highly suspicious cancer). Patients enrolled in the trial will be randomized to standard of care preoperative assessment versus PATH geriatric care arm.

Conditions

• Frailty
• Oncology Problem
• Cognitive Impairment

Interventions

Type	Name	Description
OTHER	Geriatric assessment	Geriatric assessment through PATH clinic which includes an evaluation of comorbidities, health trajectory and baseline frailty as well as conducting an in-depth discussion with the patient on how frailty stage impacts decision-making about surgery in order to co-develop a care plan.

Timeline

• Start date: 2024-01-31
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2023-09-05
• Last updated: 2024-08-23

Locations

1 site across 1 country: Canada