Pre-Operative Prehabilitation Program Women With Gynecological Cancer

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06176274
• Other study ID #: IstanbulUC-LEE-HE-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: June 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Hilal EVGIN, Phd Student
• Phone: 800-525-5552
• Email: hilalevgin.94[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer
• Prehabilitation

Intervention

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.

Locations

Country	Name	City	State
Turkey	Prof Dr Cemil Tasçioglu City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	day of hospital stay	the length of hospital stay	1 weeks
Primary	the WHODASS proficiency scale	the WHODASS proficiency scale will be used. It is useful for a brief assessment of the overall functionality.	1 weeks