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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07085000
Acronym
GYNCOGFRAIL
Enrollment
68
Registered
2025-07-25
Start date
2025-05-10
Completion date
2025-08-15
Last updated
2025-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Frailty, Geriatric Oncology, Gynecologic Cancer

Keywords

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

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.

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.

Interventions

OTHERNo 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.

Sponsors

Izmir City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Decision Satisfaction ScoreFrom 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.

Secondary

MeasureTime frameDescription
Preoperative Cognitive Function (MoCA)Up to 1 day before surgeryCognitive function will be evaluated preoperatively using the Montreal Cognitive Assessment (MoCA), which assesses multiple cognitive domains. Lower scores indicate worse cognitive performance.
Preoperative Physical Frailty (CFS)Up to 1 day before surgeryPhysical frailty will be assessed preoperatively using the Clinical Frailty Scale (CFS), with higher scores indicating greater frailty.
Postoperative Adaptation ScoreFrom the day of surgery to 30 days after surgeryA composite adaptation score will be assessed to evaluate postoperative recovery and behavioral adaptation. This score includes parameters such as early postoperative mobilization (e.g., time to ambulation), respiratory exercises compliance (e.g., frequency of incentive spirometry use), medication adherence, attendance to scheduled follow-ups, and return to baseline functional status. Higher scores indicate better postoperative adaptation.
Length of Hospital StayFrom date of surgery until hospital discharge, assessed up to 14 daysThe number of days from the date of surgery to hospital discharge will be recorded as the length of hospital stay.
30-Day Postoperative ComplicationsWithin 30 days after surgeryPostoperative complications occurring within 30 days of surgery will be recorded and classified according to the Clavien-Dindo classification system.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026