Preoperative Cognitive and Physical Frailty as Predictors of Decision Satisfaction and Postoperative Adaptation in Geriatric Gynecologic Oncology Patients: A Pilot Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Postoperative Decision Satisfaction Score
研究概览
简要总结
This prospective observational study aims to evaluate the association between preoperative cognitive function, measured by the Montreal Cognitive Assessment (MoCA), and physical frailty, assessed using the Clinical Frailty Scale (CFS), with postoperative decision satisfaction and adaptation in geriatric patients undergoing gynecologic cancer surgery. Approximately 60 to 70 female patients aged 65 years or older will be enrolled. Participants will complete preoperative assessments of cognitive status and frailty. Postoperative outcomes including decision satisfaction, medication adherence, mobilization, respiratory exercise compliance, and return to functional baseline will be evaluated. The study is conducted at İzmir City Hospital and is designed to generate preliminary data to inform larger-scale research.
详细描述
The study is designed as a prospective observational investigation involving geriatric female patients diagnosed with gynecologic cancers, including endometrial, ovarian, cervical, and vulvar malignancies. All participants are scheduled for elective surgical procedures at İzmir City Hospital. The primary objective is to explore the relationship between preoperative cognitive status, assessed by the Montreal Cognitive Assessment (MoCA), and physical frailty, assessed by the Clinical Frailty Scale (CFS), with postoperative decision satisfaction and multidimensional adaptation.
Decision satisfaction will be measured using the Decision Regret Scale (DRS) within the first postoperative week. Postoperative adaptation will be evaluated through a composite score that includes early mobilization, adherence to respiratory exercises (such as incentive spirometry), medication adherence, attendance at follow-up appointments, and return to baseline functional capacity, assessed at postoperative day 30.
Approximately 60 to 70 participants will be enrolled. Data will be analyzed using descriptive statistics, correlation analysis, and multivariable regression to identify the predictive value of cognitive and frailty assessments on postoperative outcomes. The findings are expected to contribute to the development of personalized perioperative care strategies for older adults with gynecologic cancers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 65 years or older
- •Diagnosed with a gynecologic malignancy (endometrial, ovarian, cervical, or vulvar cancer)
- •Scheduled for elective surgery with curative or staging intent
- •Ability to provide informed consent
- •Ability to complete preoperative cognitive (MoCA) and frailty (CFS) assessments
排除标准
- •Diagnosis of severe dementia or MoCA score <10
- •Undergoing emergency surgery
- •Patients under exclusive palliative care
- •Non-Turkish speaking or inability to comprehend study assessments
- •Presence of severe psychiatric conditions interfering with cognitive assessment
结局指标
主要结局
Postoperative Decision Satisfaction Score
时间窗: From the day of surgery to postoperative day 15.
Decision satisfaction will be assessed using the Decision Regret Scale (DRS) on postoperative day 15. The scale measures the patient's satisfaction with the surgical decision-making process, with higher scores indicating greater regret.
次要结局
- Preoperative Cognitive Function (MoCA)(Up to 1 day before surgery)
- Preoperative Physical Frailty (CFS)(Up to 1 day before surgery)
- Postoperative Adaptation Score(From the day of surgery to 30 days after surgery)
- Length of Hospital Stay(From date of surgery until hospital discharge, assessed up to 14 days)
- 30-Day Postoperative Complications(Within 30 days after surgery)