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

Izmir City Hospital

Status: Completed

Conditions: Cognitive Impairment; Gynecologic Cancer; Frailty; Geriatric Oncology

Treatments: Other: No Intervention - Observational Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT07085000

ISHGGO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

68 participants in 1 patient group

Geriatric Gynecologic Cancer Patients

Description:

This cohort includes female patients aged 65 years or older with a diagnosis of gynecologic malignancy who are scheduled for elective surgery. Cognitive status and physical frailty will be assessed preoperatively, and participants will be followed postoperatively to evaluate decision satisfaction and adaptation parameters.

Treatment:

Other: No Intervention - Observational Assessment