Prehabilitation to Improve Cancer Surgery Outcomes (PICaSO): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 128
- 试验地点
- 3
- 主要终点
- Global Health Score
研究概览
简要总结
This is a randomized control trial aiming to investigate the use of a prehabilitation regimen for patients undergoing major GI cancer surgery and its effects on measurements of HRQOL, LOS, and post-operative complications. Participants will be randomized to either the Prehabilitation arm or the Usual Care arm (control group). The Prehabilitation arm will be prescribed both physical and psychological prehabilitation prior to undergoing surgery for their GI cancer. The Usual Care arm will be counseled to continue their current level of activity and given the information on exercise as outlined in the Cancer Care Ontario guidelines. Participants in the Usual Care arm will also be given the same activity tracker as patients in the Prehabilitation arm in order to eliminate the activity tracker as an intervention itself. Clinical, patient-reported outcomes and health system outcomes will be evaluated. Outcomes will be measured at consent (baseline), immediately preoperatively, and postoperatively at 1, 3 and 6 months. The investigators will collect measures of recruitment, attrition and self-reported compliance via a log completed by the coordinator during weekly patient phone calls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Fluent in English
- •Able to comply with study procedures & follow-up contained within the consent form
- •Pathologically or radiologically confirmed diagnosis of a GI cancer
- •GI cancer must be considered operable
- •Expected LOS ≥ 5 days as calculated by the validated American College of Surgeons Surgical Risk Calculator
- •> 21 days between time of randomization and time of expected surgery
- •Patient written, informed consent obtained according to ICH GCP guidelines and local regulations
排除标准
- •< 18 years old
- •Not fluent in English
- •Planned resection of bony pelvis, limbs, or major lower extremity neurovascular structures
- •Significant comorbidity including any of the following:
- •Canadian Cardiovascular Society class III/IV coronary disease
- •New York Heart Association class III/IV congestive heart failure
- •Neurologic or musculoskeletal disorder prohibiting exercise
- •Major neuropsychiatric disorder
结局指标
主要结局
Global Health Score
时间窗: Baseline to postoperative day 90
The primary outcome is the difference between the baseline and 90-day global health score on the European Organization for the Research and Treatment of Cancer (EORTC) QLC-C30
次要结局
- Presence and severity of postoperative complications(Postoperatively through to day 30 and day 90)
- Changes in health-related quality of life from baseline(Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months)
- Presence and severity of symptoms(Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months)
- Postoperative hospital length of stay(Length of stay will be calculated from the date of surgery until to the date of discharge from the hospital, reported in days, assessed up to 6 months postoperatively.)
- Changes in functional capacity from baseline(Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months)
- Changes in self-reported physical activity from baseline(Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months)
- Changes in anxiety and depression from baseline(Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months)
- Changes in fatigue from baseline(Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months)
- Interference with occupational performance and productivity(Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months)
- Changes in multidimensional social support(Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months)
- Health care utilization(post-operatively at 3 and 6 months)
- Changes in attachment (closeness in relationships with others)(Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months)