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

Study Overview
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Brief Summary
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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 and screened as severely frail or cognitively impaired. 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
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At Nova Scotia Health Authority (NSHA), geriatric medicine colleagues developed a preoperative palliative and therapeutic harmonization (PATH) clinic with the following objectives: Assess medical conditions, health trajectory, and baseline frailty. 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 or gastrointestinal cancers. Patients enrolled in the trial will be randomized to standard of care preoperative assessment versus PATH geriatric care arm.

Official Title
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Application of the Palliative and Therapeutic Harmonization (PATH) Program for Shared-decision Making for Severely Frail or Cognitively Impaired Patients Scheduled for Cancer Surgery: a Randomized Control Trial.

Conditions
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Frailty, Oncology Problem, Cognitive Impairment

Intervention / Treatment
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* Other: Geriatric assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have a pathologically confirmed diagnosis of bronchopulmonary, oropharyngeal, orthopaedic, gynaecological, breast or gastrointestinal cancer surgery. Patients must be scheduled and consented for curative or palliative intent surgery. Patients must be aged 75 or older. 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: Patients cannot be a resident in a long-term care facility prior to the cancer diagnosis. Urgent/ emergent cases are excluded.

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care<br>Patients will undergo the usual preoperative assessment from preoperative clinic which includes standard general internal medicine and anesthesia assessment. | |
| Experimental: PATH geriatric care<br>Pre-operative assessment through the PATH clinic | Other: Geriatric assessment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time 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. | At 6 months postoperatively | 
| Preoperative factors associated with decreased proportion of time spent at home at 6 months. |  | At 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Assessed from date of index surgery to 6 months postoperatively. | 
| Preoperative factors associated with increased home care utilization, death, or new onset disability. |  | 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. | 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. | Assessed from date of hospital discharge (from index surgery) to 6 months postoperatively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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frailty, cognitive impairment, cancer surgery