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临床试验/NCT07720089
NCT07720089尚未招募不适用

Development and Implementation of Pilot Postoperative Guidelines to Improve Functional Outcomes Following High-Risk Surgery for Cancer: A North American Prospective Feasibility Study

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2027年9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
尚未招募
入组人数
66
试验地点
1
主要终点
Algorithmic Guideline for Functional Recovery following Cancer Surgery

研究概览

简要总结

The objective of this study is to develop and evaluate the implementation of novel timeline-specific National Comprehensive Cancer Network (NCCN)-style clinical guidelines designed to improve functional outcomes after high-risk abdominal surgery for cancer.

详细描述

This is a prospective, feasibility, and effectiveness trial to be conducted at The University of Alabama at Birmingham. We plan to develop algorithmic guidelines focused on proactive support of surgical recovery and will then recruit surgeons who care for adults undergoing high-risk abdominal surgery for cancer to study the preliminary effectiveness of implementing the algorithmic guidelines into postoperative care workflows at 4 pre-determined timepoints. A modified Delphi process will be used to ensure an expert consensus on the algorithmic guideline content is achieved through a rigorous and consensus-driven process. Two rounds of structured online voting will be conducted to rate and refine each algorithmic guideline component.

Key feasibility outcomes include recruitment and retention rates, surgeon adherence, data completeness, and integration into routine workflows. Preliminary effectiveness will be measured using patient-reported outcomes, timeliness of referral to supportive providers and resources, use of supportive services, rates of surgical regret, and measures of functional recovery.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Surgeons who perform abdominal surgery for cancer at the study institution

排除标准

  • Surgeons who do not perform abdominal surgery for cancer
  • Surgeons who are external to the study institution

研究组 & 干预措施

Surgeons

Experimental

Surgeons will be given a postoperative decision support guideline for assessment of functional recovery

干预措施: Algorithmic Guideline for Functional Recovery following Cancer Surgery (Behavioral)

结局指标

主要结局

Algorithmic Guideline for Functional Recovery following Cancer Surgery

时间窗: 6 months

The primary outcome is surgeon use of the novel guideline to guide the postoperative clinical care of patients recovering from GI cancer surgery. This will be measured by in-clinic fidelity monitoring, i.e. researcher monitoring of clinical use of the developed guideline.

Rate of Surgeon Utilization of the Algorithmic Guidelines for Functional Recovery following Cancer Surgery

时间窗: 6 months

The primary outcome is surgeon use of the novel guideline to guide the postoperative clinical care of patients recovering from GI cancer surgery. This will be measured by in-clinic fidelity monitoring, i.e. researcher monitoring of clinical use of the developed guideline.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kimberly Kopecky, MD, MSCI

Assistant Professor

University of Alabama at Birmingham

研究点 (1)

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