Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Hospital Length Of Stay
研究概览
简要总结
The purpose of this research study is to addresses the challenge of managing the unique perioperative needs of older cancer patients undergoing surgical resection.
详细描述
In the proposed study, the investigators will conduct a randomized controlled trial of a perioperative geriatrics intervention versus usual care in older patients with gastrointestinal (GI) cancers undergoing surgical resection. The perioperative geriatrics intervention will entail pre- and post-operative geriatric care for patients age ≥65 undergoing surgery for gastrointestinal cancers. Specifically, geriatric clinicians will evaluate and manage patients preoperatively in the outpatient setting and postoperatively in the inpatient setting as a consultant.
The investigators will evaluate the effect of the perioperative geriatrics intervention on postoperative length of stay (primary outcome) and readmissions in a sample of 160 patients. The investigators will also assess the impact of the perioperative geriatrics intervention on patient-reported outcomes, including quality of life (QOL) and symptom burden.
The study will take place at Massachusetts General Hospital.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 or older
- •Diagnosed with pancreatic, esophageal, rectal, colon, hepatobiliary, or gastric cancer (including patients with prior diagnosis of another cancer)
- •Planning to receive surgical resection at MGH (including both curative and palliative resections)
- •Verbal fluency in English
排除标准
- •Unwilling or unable to participate in the study
- •Significant uncontrolled psychiatric disorder (e.g. psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (e.g. dementia, cognitive impairment) which the treating clinician believes prohibits informed consent or participation in the study
结局指标
主要结局
Hospital Length Of Stay
时间窗: 2 years
Hospital length of stay from admission to discharge
次要结局
- 30-day readmission rate(2 years)
- Time to readmission(2 years)
- Change In patients' QOL From Baseline To Post-Intervention(For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)])
- Change In Patients' Symptom Scores From Baseline To Post-Intervention(For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)])
- Change In Patients' Depression From Baseline To Post-Intervention(For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)])
- Rates Of Post-Intervention Depression Symptoms(For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)])
- Rates Of Post-Intervention Moderate/Severe Symptoms(For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)])
- Change In Activities of Daily Living (ADLs) / Instrumental Activities of Daily Living (IADLs) From Baseline To Post-Intervention(For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)])
- Change In The Number Of Falls During The Past 6 Months (measured continuously) From Baseline To Post-Intervention.(For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)])
- Rates Of Post-Intervention Activity of Daily Living (ADL) Deficits(For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)])
- Rates Of Post-Intervention Instrumental Activity of Daily Living (IADL) Deficits(For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)])
- Rates Of Post-Intervention Falls(For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)])
研究者
Ryan Nipp
MD
Massachusetts General Hospital