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

Last updated: August 21, 2024
Sponsor: Nova Scotia Health Authority
Overall Status: Active - Recruiting

Phase

N/A

Condition

Learning Disorders

Dementia

Mild Cognitive Impairment

Treatment

Geriatric assessment

Clinical Study ID

NCT06022666
PATHTrial
  • Ages > 75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients must have a clinically highly suspicious or pathologically confirmeddiagnosis of bronchopulmonary, oropharyngeal (including head and neck surgery),orthopaedic, gynaecological, breast, genitourinary or gastrointestinal cancersurgery.

  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.

  1. Informed consent for participation must be received.

Exclusion

Exclusion Criteria:

  1. Patients cannot be a resident in a long-term care facility prior to the cancerdiagnosis.

  2. Urgent/ emergent cases are excluded.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Geriatric assessment
Phase:
Study Start date:
January 31, 2024
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • QEII, Victoria General Hospital

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Active - Recruiting

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