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

Nova Scotia Health Authority (NSHA)

Status: Enrolling

Conditions: Cognitive Impairment; Oncology Problem; Frailty

Treatments: Other: Geriatric assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT06022666

PATHTrial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must have a clinically highly suspicious or pathologically confirmed diagnosis of bronchopulmonary, oropharyngeal (including head and neck surgery), orthopaedic, gynaecological, breast, genitourinary or gastrointestinal cancer surgery.
2. Patients must be scheduled and consented for curative or palliative intent surgery.
3. Patients must be aged 75 or older.
4. Patients must be screened by the CFS to have:

4a. Mild or greater frailty (CFS equal or greater than 5) due to cognitive impairment.

4b. Moderate or greater frailty (CFS equal or greater than 6) due to medical/physical conditions.

5. Informed consent for participation must be received.

Exclusion criteria

1. Patients cannot be a resident in a long-term care facility prior to the cancer diagnosis.
2. Urgent/ emergent cases are excluded.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Standard of care

No Intervention group

Description:

Patients will undergo the usual preoperative assessment from preoperative clinic which includes standard general internal medicine and anesthesia assessment.

PATH geriatric care

Experimental group

Description:

Pre-operative assessment through the PATH clinic

Treatment:

Other: Geriatric assessment