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Pre-Operative Prehabilitation Program Women With Gynecological Cancer

NCT ID: NCT06176274

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Gynecologic Cancer Prehabilitation

Keywords

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Prehabilitation cancer Gynecologic cancer nursing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a randomized trial with experimental design with pre-test post-test control group
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
the experimental group will receive care through the prehabilitation program, while the control group will receive standard nursing care. participants will not know which group they are in.

Study Groups

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the experimental group

a prehabilitation program will be applied before the surgery.

Group Type EXPERIMENTAL

Prehabilition program

Intervention Type OTHER

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.

The Control Group

he will receive standard nursing care procedure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Hilal Evgin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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hilal Evgin, Phd Student

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Locations

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Prof Dr Cemil Taşçıoğlu City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Hilal EVGİN, Phd Student

Role: CONTACT

Phone: 800-525-5552

Email: [email protected]

Facility Contacts

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Role: primary

Other Identifiers

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IstanbulUC-LEE-HE-01

Identifier Type: -

Identifier Source: org_study_id