Gynecologic Oncology Patient
Conditions
Brief summary
The goal of this clinical trial is to evaluate the role of multimodal Prehabilitation program on improve surgical outcomes after gynecological oncology surgery.
Detailed description
Multimodal prehabilitation program focused on improving woman physical and psychological wellbeing before gynecological oncology surgery. Multimodal prehabilitation refers to a combination of preoperative interventions targeting physical, nutritional, psychological, and medical optimization. This program included various element such preoperative physical exercise, nutritional support, psychological counselling, social support and education about surgical processes. Multimodal Prehabilitation programs play an important role in improving surgical outcomes after gynecological oncology surgery.
Interventions
PROCEDUREgroup (B) Prehabilitation care combine with ERAS post-operative care
intervention will includes receiving prehabilitation care combine with ERAS post-operative care.
Sponsors
Assiut University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed woman with gynecologic cancer by imaging &histopathology * Accept participation in the study.
Exclusion criteria
* Patient with advanced and metastatic stage * Patient who received neoadjuvant chemotherapy * Patient who have psychological disorder such as suicidal attempt * Patient who have cerebral stroke, hemiplegia or paralyses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changing the postoperative morbidity | up to 30 days postoperative | compare the 30 days postoperative morbidity of the prehabilitation and conventional group, it included (Assess the post-operative complications by using Clavien-Dindo classification; from Grade I-IV; higher grades indicate more severe complications.) |
| changing the postoperative mortality | up to 30 days postoperative | compare the 30 days postoperative mortality of the prehabilitation group and conventional group. |
| Pain intensity measured by the Visual Analog Scale (VAS) for pain. | up to 30 days postoperative | compare the 30 days postoperative Pain intensity; Unit of Measure: Units on a scale (0-10 cm). Scale: 0 = no pain, 10 = worst pain imaginable; higher scores indicate worse pain of the prehabilitation group and conventional group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| assess and changing the Nutritional Status of the prehabilitation group | up-to 30 days postoperative | Nutritional Status measured through the following: 1. Nutritional Status - Height/m Description: Patient height measured in meters. 2. Nutritional Status - Weight/kg Description: Patient body weight measured in kilograms. * weight and height combined to report BMI in kg/m\^2 |
| change the length of the hospital stay | up to 5 days post-operative | compare the days of the hospital stay between the prehabilitation group and conventional group to measure the effect of the intervention program in changing the length of hospital stays (Number of days from surgery until hospital discharge). |
| improve the Cardiopulmonary fitness of gynecological oncology patient after surgery | up-to 15 days preoperatively & up to 30 days post operatively] | Cardiopulmonary Fitness measured by use of: 1- 6-Minute Walk Test (6MWT) Distance * Description: Distance walked in meters. * Time Frame: Up to 30 days post operatively . |
| Enhance the physical state of gynecological oncology patient using the Eastern Cooperative Oncology Group (ECOG) | through the postoperative period within two hours up-to 30 days after surgery | \- Eastern Cooperative Oncology Group (ECOG) is a performance method used to assess a cancer patient's level of functioning and ability to care for themselves, work, and carry out daily activities. ECOG Performance Status Scale included 5 grades from 0- 5 * Grade 0: Fully active, able to carry all activities without restriction. * Grade 1: Restricted in physically and able to do light work * Grade 2: Ambulatory and capable of self-care, but unable to carry out any work activities; up \>50% of waking hours. * Grade 3: Capable of only limited self-care; confined to bed or chair \>50% of waking hours. * Grade 4: Completely disabled; cannot carry on any self-care; totally confined to bed or chair. * Grade 5: Dead. |
| Enhance the psychological wellbeing of gynecological oncology patient | up-to 15 days preoperatively & up to 30 days post operatively] | \- measure the Psychological aspect by using DASS21(Depression, Anxiety, and Stress Scale - 21 items): . 1- Depression * Unit of Measure: Units on a scale (0-42). * Scale: Higher scores indicate worse depression. 2- Anxiety * Unit of Measure: Units on a scale (0-42). * Scale: Higher scores indicate worse anxiety. 3- Stress * Unit of Measure: Units on a scale (0-42). * Scale: Higher scores indicate worse stress |
Countries
Egypt
Outcome results
None listed