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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Time spent at home 6 months following cancer surgery.
研究概览
简要总结
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.
详细描述
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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
- •Informed consent for participation must be received.
排除标准
- •Patients cannot be a resident in a long-term care facility prior to the cancer diagnosis.
- •Urgent/ emergent cases are excluded.
结局指标
主要结局
Time spent at home 6 months following cancer surgery.
时间窗: 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.
时间窗: At 6 months postoperatively
次要结局
- Number of participants requiring home care utilization(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.(Assessed from date of index surgery to 6 months postoperatively.)
- 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.)
- Preoperative factors associated with increased home care utilization, death, or new onset disability.(Assessed up to 6 months postoperatively.)
- Decision regret scores.(Assessed from date of hospital discharge (from index surgery) to 6 months postoperatively.)