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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
150
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.
QEII, Victoria General Hospital
Halifax, Nova Scotia, Canada
RECRUITINGTime spent at home 6 months following cancer surgery.
Number of days spent at home vs in a hospital or care-facility unit dichotomized as low vs high time at home. High time at home defined as 14 or fewer institution days, and low time defined as more than 14 institution days at 6 months.
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
Number of participants requiring home care utilization
Receipt of any homeware service (nursing, wound care, social workers, physiotherapy) from the day of postoperative discharge from the hospital.
Time frame: Assessed from date of hospital discharge (from index surgery) to 6 months postoperatively.
Number of participants experiencing death or development of persistent significant new disability.
Participant passing away or developing a new disability, from the day of index surgery. Assessed using the WHODAS 2.0 disability scale.
Time frame: Assessed from date of index surgery to 6 months postoperatively.
Preoperative factors associated with increased home care utilization, death, or new onset disability.
Time frame: Assessed up to 6 months postoperatively.
Rate of change to a non-operative strategy
Rate of patients randomized to PATH clinic arm that end up declining surgery after consultation.
Time frame: Assessed from date of randomization until documented confirmation that patient has opted for non surgical approach, assessed up to 6 months.
Decision regret scores.
Decisional Regret Scale ranging from 0-100 scores measure the distress or remorse regarding the patient's decision made about undergoing surgery.
Time frame: Assessed from date of hospital discharge (from index surgery) to 6 months postoperatively.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.