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

NCT07085000 | Completed

• 1 other identifier: ISHGGO
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gynecologic Cancer; Frailty; Cognitive Impairment; Geriatric Oncology

Keywords

Cognitive Function; Frailty; MoCA; CFS; Decision Satisfaction; Postoperative Recovery; Geriatric Patients; Gynecologic Surgery; Patient-Reported Outcomes

Outcome Measures

Primary Outcomes (1)

• Postoperative Decision Satisfaction Score

  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.

  From the day of surgery to postoperative day 15.

Secondary Outcomes (5)

• 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

Study Arms (1)

Geriatric Gynecologic Cancer Patients

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.

Other: No Intervention - Observational Assessment

Interventions

No Intervention - Observational Assessment OTHER

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.

Geriatric Gynecologic Cancer Patients

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: Only biologically female patients are eligible to participate, regardless of gender identity.
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older female patients diagnosed with gynecologic malignancies who are scheduled for elective surgery at İzmir City Hospital. The study population represents a typical geriatric oncologic cohort in a tertiary referral center.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir City Hospital: lead

Study Sites (1)

İzmir City Hospital

Izmir, 35020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Frailty; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Celal Akdemir, MD

  Izmir City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 25, 2025
• Study Start: May 10, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 15, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

TU (1)