NCT07085000

Cognitive and Physical Frailty as Predictors of Decision Satisfaction in Geriatric Gynecologic Oncology

Preoperative Cognitive and Physical Frailty as Predictors of Decision Satisfaction and Postoperative Adaptation in Geriatric Gynecologic Oncology Patients: A Pilot Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 68 (actual)
• Sponsor: Izmir City Hospital · Other Government
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gynecologic Cancer
• Frailty
• Cognitive Impairment
• Geriatric Oncology

Interventions

Type	Name	Description
OTHER	No Intervention - Observational Assessment	No intervention is applied. Preoperative cognitive status (MoCA) and physical frailty (CFS) are assessed as part of observational data collection. Postoperative follow-up includes decision satisfaction and adherence evaluations.

Timeline

• Start date: 2025-05-10
• Primary completion: 2025-08-01
• Completion: 2025-08-15
• First posted: 2025-07-25
• Last updated: 2025-08-17

Locations

1 site across 1 country: Turkey (Türkiye)