Cognitive Impairment, Frailty, Oncology Problem
Conditions
Keywords
frailty, cognitive impairment, cancer surgery
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.
Interventions
OTHERGeriatric 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.
Sponsors
Nova Scotia Health Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time spent at home 6 months following cancer surgery. | At 6 months postoperatively | 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. |
| Preoperative factors associated with decreased proportion of time spent at home at 6 months. | At 6 months postoperatively | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative factors associated with increased home care utilization, death, or new onset disability. | Assessed up to 6 months postoperatively. | — |
| Number of participants requiring home care utilization | Assessed from date of hospital discharge (from index surgery) to 6 months postoperatively. | Receipt of any homeware service (nursing, wound care, social workers, physiotherapy) from the day of postoperative discharge from the hospital. |
| Decision regret scores. | Assessed from date of hospital discharge (from index surgery) to 6 months postoperatively. | Decisional Regret Scale ranging from 0-100 scores measure the distress or remorse regarding the patient's decision made about undergoing surgery. |
| Rate of change to a non-operative strategy | Assessed from date of randomization until documented confirmation that patient has opted for non surgical approach, assessed up to 6 months. | Rate of patients randomized to PATH clinic arm that end up declining surgery after consultation. |
| Number of participants experiencing death or development of persistent significant new disability. | Assessed from date of index surgery to 6 months postoperatively. | Participant passing away or developing a new disability, from the day of index surgery. Assessed using the WHODAS 2.0 disability scale. |
Countries
Canada
Contacts
Primary ContactRichard Spence, MD, FRCSC
Backup ContactDamsadie Hannedige, BSc, MSc
Outcome results
None listed