Pilot Study of a Geriatric Intervention After Colorectal and Lung Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Feasibility of the Intervention
研究概览
简要总结
Surgery for colorectal cancer is a major surgery. People above the age of 60 tend to have a higher risk of complications. Some studies indicate that senior cancer patients might benefit from a home support after surgery by a geriatric nurse practitioner and a team, beside their usual post-operative care. The investigators team is planning a large study to assess whether this approach could help patients with colorectal cancer recover better from their surgery, get better cancer treatment after that (e.g. chemotherapy), and possibly live longer. This study you are asked to take part in is a pilot for this large study.
详细描述
Our key background data come from the randomized study conducted by McCorkle et al.
After evaluation testing, patients will be randomly assigned (similarly to a coin toss) to one of two possible follow-up groups. One would be a regular post-surgery care group (control group), the other will have in addition a support by geriatric nurse practitioner (intervention group).
Patients who are assigned to the intervention group: once they arrive home, in addition to their normal post-surgery care, will receive a once a week home visit by a geriatric nurse practitioner (GNP). The GNP will also call the patient once a week in between. The GNP will check any problem patients may have during their recovery and provide or organize care for it. The GNP has a checklist of problems to address so that we can reliably reproduce our intervention in other patients. The GNP will work together with the patient's various doctors and caregivers, as well as a geriatric team. Some of the visits or the telephone calls maybe tape-recorded so that the research team can evaluate the information provided to the patient. We will record any complication patients might have from surgery.
No matter which treatment group the patient is assigned to, at the end of a 4 weeks period, we will repeat the tests we did at the beginning to see how they change.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colorectal cancer, stage III or IV, confirmed by histology
- •Abdominal surgery by a University of South Florida (USF) surgeon at Moffitt Cancer Center or Tampa General Hospital (TGH)
- •Age 60 years and older
- •Informed consent
- •Living within a one (1) hour radius of Moffitt
排除标准
- •Discharge planned to a rehabilitation facility or a nursing home
- •Unable to answer the questionnaires (e.g. because of cognitive impairment, blindness, deafness)
- •Post-operative inpatient stay >one (1) month
结局指标
主要结局
Feasibility of the Intervention
时间窗: 30 days per participant
The primary end-point for the pilot will be the feasibility of the intervention, measured as follows: * A compliance of \>=90% with the intervention table on page 17 * A success rate (improvement or resolution of problems) of \>= 80% * A completion rate of \>=90% of the initial and final study questionnaires
次要结局
- Whether the Intervention is Faithful to Dr. McCorkle's Original Intervention(30 days per participant)
- A Successful Collection and Testing of >=90% of the Samples Tested(30 days per participant)
- Effect Size Estimates for Within-group Changes Between Baseline and 1-month(30 days per participant)