Pre-Operative Prehabilitation Program Women With Gynecological Cancer

NCT06176274 | Unknown

• 1 other identifier: IstanbulUC-LEE-HE-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gynecologic Cancer; Prehabilitation

Keywords

Prehabilitation; cancer; Gynecologic cancer; nursing

Outcome Measures

Primary Outcomes (4)

• the Quality of Recovery QoR-15

  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

  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

  the length of hospital stay

  1 weeks

• the WHODASS proficiency scale

  the WHODASS proficiency scale will be used. It is useful for a brief assessment of the overall functionality.

  1 weeks

Study Arms (2)

the experimental group

EXPERIMENTAL

a prehabilitation program will be applied before the surgery.

Other: Prehabilition program

The Control Group

NO INTERVENTION

he will receive standard nursing care procedure.

Interventions

Prehabilition program 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 experimental group

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are not stage 4 in preoperative evaluation
• Who volunteered to participate in the study
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Prof Dr Cemil Taşçıoğlu City Hospital

Istanbul, 34400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• hilal Evgin, Phd Student

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilal EVGİN, Phd Student

CONTACT

800-525-5552; hilalevgin.94@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: a randomized trial with experimental design with pre-test post-test control group

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: December 19, 2023
• Study Start: January 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 19, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)