Pre-Operative Prehabilitation Program Women With Gynecological Cancer

December 18, 2023 updated by: Hilal Evgin, Istanbul University - Cerrahpasa (IUC)

The Effect of Pre-Operative Prehabilitation Program on Postoperative Recovery in Women With Gynecological Cancer

The aim of this study is to determine the effect of the prehabilitation program applied to postmenopausal women diagnosed with gynecological cancer before surgery on postoperative recovery, planned as a randomized study with an experimental design with a pre-test post-test control group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of prehabilitation programs is to eliminate intraoperative complications by increasing the functional capacity and metabolic reserves of patients before surgical treatment and to accelerate recovery in the postoperative period. In addition, it helps the patient to maximize the existing capacity of the patient before the surgery, to know what will happen at each stage of the treatment to be applied to the patient, to feel better physically and spiritually and to understand the roles and responsibilities of the individual care of the patient, as well as making a significant contribution to the positive results of the operation. It is to provide exercise, psychological support, nutritional counseling and optimization of the underlying conditions by stopping negative health behaviors. There are non-eliminable criteria such as age, gender, comorbid diseases before surgery, as well as modifiable factors such as the regulation of the patients nutrition, ensuring psychological well-being, quitting smoking. In particular, some factors directly affect the state of well-being during the perioperative period. Thus, surgeries become safer.As a practice, the prehabilitation program (according to the surgery program) is planned in the preoperative period between 2-4 weeks Dec. Participants who do not comply with the program will be excluded from the sample

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • İstanbul, Turkey, 34400
        • Prof Dr Cemil Taşçıoğlu City Hospital
        • Contact:
          • Phone Number: 800-525-5552
        • Principal Investigator:
          • hilal evgin, Phd Student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients who are not stage 4 in preoperative evaluation
  • Who volunteered to participate in the study
  • 6 months have passed since the last treatment (Chemoretapy, Radiotherapy)
  • Women who do not have Turkish literacy problems
  • Women aged 50 and older who are in the postmenopausal period
  • Patients who are scheduled for abdominal surgery

Exclusion Criteria:

  • High-risk comorbid diseases such as COPD, heart failure
  • Physical and mental conditions that will interfere with nutrition and exercise
  • Those with orthopedic and neuromuscular diseases
  • Those who are scheduled for surgery by laparoscopic/laparotomic method
  • Those who cannot adapt to the program during the preoperative period
  • Women who are too depressed during preoperative evaluation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: the experimental group
a prehabilitation program will be applied before the surgery.
Other: Prehabilition program
this program includes nutrition, physical activity, medical optimization and psychological support interventions.As a practice, the prehabilitation program (according to the surgery program) is planned in the preoperative period between 2-4 weeks Dec. it will be applied for 4 weeks before surgery. the first meeting is scheduled for 40 minutes. the program compliance process will be monitored by phone weekly. postoperative recovery and functional capacity measurements will be performed.
No Intervention: The Control Group
he will receive standard nursing care procedure.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the Quality of Recovery QoR-15
Time Frame: 6 weeks
The scale is based on the assumption that the higher the score, the better the quality of improvement when measuring between 0 and 150 points. The scale is based on the assumption that the higher the score, the better the quality of Deceleration.
6 weeks
functional capacity 6MWT
Time Frame: 10 weeks
6MWT has also been used to determine the functional status of patients . During the test, a standardized protocol is followed by walking on a flat floor for 6 minutes. It is a self-paced test and is a repeatable, cheap and easy test (unlike the increasingly brisk walking tests that require intervention).
10 weeks
day of hospital stay
Time Frame: 1 weeks
the length of hospital stay
1 weeks
the WHODASS proficiency scale
Time Frame: 1 weeks
the WHODASS proficiency scale will be used. It is useful for a brief assessment of the overall functionality.
1 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa (IUC)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: hilal Evgin, Phd Student, Istanbul University - Cerrahpasa (IUC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IstanbulUC-LEE-HE-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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