Gynecologic CancerGYNCOGFRAILNCT07085000
Cognitive and Physical Frailty as Predictors of Decision Satisfaction in Geriatric Gynecologic Oncology
An observational study of Gynecologic Cancer and Frailty, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Gynecologic Cancer, Frailty, Cognitive Impairment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2025to 15 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Cognitive and Physical Frailty as Predictors of Decision Satisfaction and Postoperative Adaptation in Geriatric Gynecologic Oncology Patients: A Pilot Observational Study
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.
Read the 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
- Being tested
- No Intervention - Observational Assessment
- Keywords
- Cognitive Function, Frailty, MoCA, CFS, Decision Satisfaction, Postoperative Recovery, Geriatric Patients, Gynecologic Surgery, Patient-Reported Outcomes
- Medical subject headings
- Frailty, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention - Observational AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention - Observational Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the day of surgery to postoperative day 15.
Secondary outcomes (5)
Preoperative Cognitive Function (MoCA)
Cognitive function will be evaluated preoperatively using the Montreal Cognitive Assessment (MoCA), which assesses multiple cognitive domains. Lower scores indicate worse cognitive performance.
Measured: Up to 1 day before surgery
Preoperative Physical Frailty (CFS)
Physical frailty will be assessed preoperatively using the Clinical Frailty Scale (CFS), with higher scores indicating greater frailty.
Measured: Up to 1 day before surgery
Postoperative Adaptation Score
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.
Measured: From the day of surgery to 30 days after surgery
Length of Hospital Stay
The number of days from the date of surgery to hospital discharge will be recorded as the length of hospital stay.
Measured: From date of surgery until hospital discharge, assessed up to 14 days
30-Day Postoperative Complications
Postoperative complications occurring within 30 days of surgery will be recorded and classified according to the Clavien-Dindo classification system.
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start10 May 2025
- Primary completion1 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Celal Akdemir, MD, Principal investigator, Izmir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085000
- Sponsor's protocol ID
- ISHGGO
- Acronym
- GYNCOGFRAIL
- Status last verified
- Aug 2025
- First submitted
- 16 Jul 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Cognitive and Physical Frailty as Predictors of Decision Satisfaction and Postoperative Adaptation in Geriatric Gynecologic Oncology Patients: A Pilot Observational Study
- ClinicalTrials.gov ID
- NCT07085000
- Acronym / sponsor ID
- GYNCOGFRAIL / ISHGGO
- Conditions
- Gynecologic Cancer, Frailty, Cognitive Impairment, Geriatric Oncology
- Keywords
- Cognitive Function, Frailty, MoCA, CFS, Decision Satisfaction, Postoperative Recovery, Geriatric Patients, Gynecologic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Izmir City HospitalOther government
- Study start
- 10 May 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric Gynecologic Cancer Patients | – | Other: No Intervention - Observational AssessmentThis 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention - Observational AssessmentNo 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. | Other | Geriatric Gynecologic Cancer Patients |
Primary outcome
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.
5 secondary outcomes
Preoperative Cognitive Function (MoCA)
Time frame: Up to 1 day before surgery
Preoperative Physical Frailty (CFS)
Time frame: Up to 1 day before surgery
Postoperative Adaptation Score
Time frame: From the day of surgery to 30 days after surgery
Length of Hospital Stay
Time frame: From date of surgery until hospital discharge, assessed up to 14 days
30-Day Postoperative Complications
Time frame: Within 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celal Akdemir, MD principal investigator
Izmir City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancer and Frailty, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Decision Satisfaction Score (time frame: From the day of surgery to postoperative day 15.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.