Recruiting

Observational Study

Sponsor:

Nova Scotia Health Authority

Code:

NCT06022666

Conditions

Frailty

Oncology Problem

Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

Geriatric assessment

Study Details

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.

Conditions

Frailty

Oncology Problem

Cognitive Impairment

Study ID

NCT06022666

Start date

Jan 31, 2024

Status verified date

Feb, 2024

Completion date

Mar, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Standard of care

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

experimental: PATH geriatric care

Pre-operative assessment through the PATH clinic

Interventions

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.

Primary outcome measure

  • Time spent at home 6 months following cancer surgery. [ Time Frame: At 6 months postoperatively ]
  • Preoperative factors associated with decreased proportion of time spent at home at 6 months. [ Time Frame: At 6 months postoperatively ]

Central Contacts and Locations

Central contacts

Richard Spence, MD, FRCSC

1 647 612 5904Richard.Spence@dal.ca

Damsadie Hannedige, BSc, MSc

902-225-8972damsadie.hannedige@nshealth.ca

Locations

QEII, Victoria General Hospital

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Contacts

Richard Spence

647-612-5904

Damsadie Hannedige

902-225-8972

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Aug 23, 2024

Last verified

Feb, 2024

Keywords

  • frailty
  • cognitive impairment
  • cancer surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2024-08-23.