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NCT Number: NCT07085000

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

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.

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Key information

Conditions

Gynecologic Cancer Cognition Disorders Cognitive Dysfunction Cognitive Impairment Frailty Geriatric Oncology Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

Female

Study type

Observational

Primary location

İzmir City Hospital

Izmir, 35020, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Postoperative Decision Satisfaction Score

    Time frame: 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.

Secondary outcomes

  1. Preoperative Cognitive Function (MoCA)

    Time frame: Up to 1 day before surgery

    Cognitive function will be evaluated preoperatively using the Montreal Cognitive Assessment (MoCA), which assesses multiple cognitive domains. Lower scores indicate worse cognitive performance.

  2. Preoperative Physical Frailty (CFS)

    Time frame: Up to 1 day before surgery

    Physical frailty will be assessed preoperatively using the Clinical Frailty Scale (CFS), with higher scores indicating greater frailty.

  3. Postoperative Adaptation Score

    Time frame: From the day of surgery to 30 days after surgery

    A 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.

  4. Length of Hospital Stay

    Time frame: From date of surgery until hospital discharge, assessed up to 14 days

    The number of days from the date of surgery to hospital discharge will be recorded as the length of hospital stay.

  5. 30-Day Postoperative Complications

    Time frame: Within 30 days after surgery

    Postoperative complications occurring within 30 days of surgery will be recorded and classified according to the Clavien-Dindo classification system.

Sponsors and collaborators

Lead sponsor

Izmir City Hospital

Other Gov

Registry information

Official study title

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

Acronym: GYNCOGFRAIL

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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