Clinical trial NCT06176274: Pre-Operative Prehabilitation Program Women With Gynecological Cancer
Official title: The Effect of Pre-Operative Prehabilitation Program on Postoperative Recovery in Women With Gynecological Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Cancer
Prehabilitation
Keywords: Prehabilitation
cancer
Gynecologic cancer
nursing
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomized trial with experimental design with pre-test post-test control group
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: the Quality of Recovery QoR-15
timeFrame: 6 weeks
measure: functional capacity 6MWT
timeFrame: 10 weeks
measure: day of hospital stay
timeFrame: 1 weeks
measure: the WHODASS proficiency scale
timeFrame: 1 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Prof Dr Cemil Taşçıoğlu City Hospital
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: hilal Evgin, Phd Student
role: PRINCIPAL_INVESTIGATOR
References: