Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 7:59 PM
Study NCT ID:
NCT06022666
Status:
RECRUITING
Last Update Posted:
2024-08-23
First Post:
2023-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PATH Program for for Severely Frail or Cognitively Impaired Patients Scheduled for Cancer Surgery.
Sponsor:
Nova Scotia Health Authority
Organization:
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: