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临床试验/NCT02082223
NCT02082223已完成不适用

Individualized Preoperative Rehabilitation (iPREHAB) Pilot

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
20
试验地点
1
主要终点
Feasibility

研究概览

简要总结

A pilot to test feasibility of improving patient/caretaker quality of life and resilience.

详细描述

Our overall goal is to investigate if pre-operative interventions can address patients' and patients' care givers quality of life/resilience deficits and thus improve outcomes. This initial pilot study will test the feasibility of offering patients and their care givers prehabilitation interventions prior to complex gastrointestinal surgery such as pancreatectomy, esophagectomy, proctectomy, or hepatectomy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients who are being seen for pancreatic, esophageal, rectal or hepatic neoplastic disease, will undergo neo-adjuvant therapy and may require complex GI surgery and their care givers.
  • •Are able and willing to participate in all aspects of the study; and
  • •Have been provided with, understand the consent.

排除标准

  • 未提供

研究组 & 干预措施

Preoperative Rehabilitation

Experimental

Patient & caregiver input regarding 'single biggest concern right now' (modified BEACON buttons) will be elicited. Information gathered by the study team which includes a trained nursing coach and the patient/caregiver will together develop an individualized 'toolbox' of possible interventions to improve preoperative quality of life.

Candidate interventions include, but not limited to: Participation in SMART program, caregiver participation in Caregivers study protocol MC1295 (IRB 13-002943), nutritional recommendations (deficiencies, immuno-nutrition), low impact resistance training/tai chi, referral to financial or counseling services, establishment of information sources & plans for concerns not frequently covered in clinical practice such as sleeplessness, spiritual assistance.

干预措施: Interventions to improve preop QOL/resilience deficits (Behavioral)

结局指标

主要结局

Feasibility

时间窗: 3 months post surgical

Primary outcome is the feasibility of the interventions as measured through the end of study feedback form.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juliane Bingener-Casey

M.D.

Mayo Clinic

研究点 (1)

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