跳至主要内容
临床试验/NCT05377970
NCT05377970招募中不适用

Implementation of a Prehabilitation Pilot Program for Individuals With Frailty Undergoing Oncologic Surgery

MaineHealth2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年6月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
MaineHealth
入组人数
20
试验地点
2
主要终点
Patient Satisfaction

研究概览

简要总结

Frailty is a state of increased vulnerability to stressors with increased rates of poor outcomes. Surgery is one of these stressors, and previous research has therefore shown increased rates of morbidity and mortality in frail patients undergoing surgery. Prehabilitation programs can help mitigate the negative outcomes associated with frailty. The investigators hope to implement a newly developed prehabilitation pilot program in the Maine Medical Center Surgical Oncology Clinic to initially evaluate adherence, self-efficacy, and health-related quality of life.

详细描述

Frailty is a state of increased vulnerability to stressors with increased rates of poor outcomes. Surgery is one of these stressors, and previous research has therefore shown increased rates of morbidity and mortality in frail patients undergoing surgery. Prehabilitation programs can help mitigate the negative outcomes associated with frailty. The investigators hope to implement a newly developed prehabilitation pilot program in the Maine Medical Center Surgical Oncology Clinic to initially evaluate adherence, self-efficacy, and health-related quality of life.

The investigators now hope to implement this prehabilitation program in the clinics at Maine Medical Center. Our long term goal is the introduce this program in all surgical specialties; but first, the investigators plan to assess adherence, patient self-efficacy, frailty and health-related quality of life through a pilot study in the surgical oncology clinic.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • Subjects ≥18 years old
  • Evaluated at Maine Medical Center by surgical oncology service
  • Planned surgical intervention for gastrointestinal oncologic condition
  • Score ≥40 on Risk Analysis Index frailty screening
  • Physically able to participate in prehabilitation exercises
  • Home internet access and established email account
  • Able to understand the English language

排除标准

  • Patients unable to participate in exercises included in prehabilitation program
  • Patients with impaired decision making capacity
  • Those in a high risk community: prisoners and pregnant women
  • Those who do not meet the above inclusion criteria

结局指标

主要结局

Patient Satisfaction

时间窗: Last day of prehabilitation program (within week prior to surgery)

Assess patient satisfaction and barriers to adherence through a post prehab program survey.

Frailty (Risk Analysis Index)

时间窗: Evaluated on Day 0 and at last visit prior to surgery, an average of 3 months

Evaluate change in frailty using Risk Analysis Index before and after participation in the prehabilitation program.

Participant adherence to prehab program

时间窗: Through study completion, on average 3 months

Evaluate adherence through analysis of patient maintained exercise logs via number of days completed

Correlation between patient pre-program self-efficacy evaluation and measured adherence to study prehabilitation program

时间窗: Through study completion, on average 3 months

Assess self-efficacy by evaluating the relationship between pre-program Self-Efficacy for Home Exercise Program Scale (0-72) score and adherence.

Quality of Life (Short Form- 36 Survey)

时间窗: Completed at Day 0, Two weeks, Four weeks and Last day of prehabilitation program (within week prior to surgery)

Evaluate change in health-related quality of life before and after participation in the prehabilitation program.

次要结局

未报告次要终点

研究者

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

Laura Nicolais

Timothy Fitzgerald: Associate Medical Director. Oncology

MaineHealth

研究点 (2)

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