ERAS (Enhanced Recovery After Surgery) protocols are step-by-step care plans that help patients recover faster after surgery. They focus on keeping the body's normal functions, lowering stress from surgery, and supporting a quicker recovery. In gynecologic cancer surgeries, ERAS has been shown to help patients do better, have fewer problems, and leave the hospital sooner. A prehabilitation program, in combination with ERAS protocols, aims to optimize patients' physical and psychological condition prior to surgery for gynecological cancers. Interventions may include tailored exercise, nutritional support, respiratory training, and psychological preparation. By enhancing baseline fitness and resilience, prehabilitation improves the body's ability to tolerate surgical stress, reduces complications, and facilitates a faster, smoother recovery within the ERAS framework.
The purpose of this study is to investigate the impact of multifactorial preoperative empowerment (pre-habilitation protocol) on patients with gynecological cancer who undergo oncological surgery. The objective of this study is to demonstrate whether the implementation of pre-habilitation program empowerment as opposed to its non-implementation leads to an improvement in quality of life, a reduction in days of hospitalization, a reduction in immediate (up to discharge) and long term (up to 40th post-surgery day) postoperative complications (as measured with the Clavien Dindo system), a reduction in hospital readmission rates, and postoperative morbidity and mortality.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
100
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The patient exercises in a structured manner with the help of a relevant interactive form/guide and simple aids (e.g. chair, step, water bottle, broomstick) by performing six categories of exercises: 1. Breathing exercises, 2. Pelvic floor exercises-pelvic mobility, 3. Upper trunk exercises, 4. Lower trunk exercises, 5. Aerobic exercises, 6. Stretching exercises, at a predetermined pace (number of repetitions) of each exercise and a limit of not exceeding the value 5-6 on the ten-point modified Borg fatigue scale. The intern records her activity on a form-"exercise log". The recommendation is the maximum implementation of the exercise program but in any case not less than 3 times a week.
General Hospital of Papageorgiou
Thessaloniki, Greece
RECRUITINGPostoperative morbidity
Systematic recording of complications based on the Clavien Dindo system, during hospitalization and in the immediate postoperative period (up to the 30th postoperative day).
Time frame: Up to the 30th post operative day
Duration of hospitalization
The discharge day is defined as the postoperative day on which the following criteria are met in their entirety: 1. adequate mobilization, 2. tolerance of solid foods and adequate oral water intake, 3. adequate analgesia only with oral analgesics, 4. mobilization of intestinal function / flatus, 5. Absence of Clavien Dindo \>II complication.
Time frame: Until the patient discharged (assessed up to 4 days)
General Quality of Life (QoL)
Use of metric tools: structured and weighted questionnaires in Greek language EORTC QLQ-C30 (version 3.0) (general quality of life). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time frame: Up to the time of discharge (assessed up to 4 days)
Time interval between the onset of adjuvant anti-neoplastic therapy
The number of days between the day of surgery and the start of adjuvant therapy (includes systemic chemotherapy/immunotherapy, external radiation, brachytherapy).
Time frame: Up to 120 days after surgery
Hospital readmission at 90 days
Any admission to a nursing facility up to the 90th postoperative day.
Time frame: Up to the 90th postoperative day
Cachexia
Assessments using unique measurements EORTC QLQ-CAX24 (cachexia). The Cancer Cachexia Module is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. The QLQ-CAX24 incorporates five multi-item scales to assess food aversion, eating and weight-loss worry, eating difficulties, loss of control, and physical decline. In addition, four single items assess dry mouth, indigestion/heartburn, forcing self to eat and inadequate information. All of the scales and single-item measures range in score from 0 to 100. A high score for the symptom scales represents a high level of symptomatology or problems.
Time frame: Up to the time of discharge (assessed up to 5 days)
Sexual Health
The EORTC Quality of Life Questionnaire Sexual Health (SH-22) is a stand-alone questionnaire, but can also be used as a supplementary questionnaire to be employed in conjunction with the QLQ-C30. The SH-22 incorporates 2 multi-item scales to assess Sexual satisfaction and Sexual pain. In addition, 11 single items assess sexual activity and cover treatment-related and partner-related questions, general questions of sexual health and 4 gender specific questions. Interpretation: All of the Multi-item scales and Single-item measures range in score from 0 to 100. A high score represents a high level of symptomatology or problems. Reporting: The two multi-item scales have a different number of items depending on whether the patient had or does not have a partner, and has or does not have sexual activity. It is advised to always report how many items were used to calculate each scale; and which ones. This will allow comparison between different subgroups of patients.
Time frame: Up to the time of discharge (assessed up to 4 days)
Quality of Life in ovarian cancer
The Ovarian Cancer Module (QLQ-OV28) is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. The QLQ-OV28 incorporates seven multi-item scales to assess body image, sexuality, attitude to disease or treatment, abdominal or gastro-intestinal symptoms, peripheral neuropathy, hormonal or menopausal symptoms and other chemotherapy side-effects. The scoring approach for the QLQ-OV28 is identical in principle to that for the \[function and/or symptom scales / single items\] of the QLQ-C30. Interpretation: All of the scales and single-item measures range in score from 0 to 100. A high score for the \[functional scales and/or single items\] represents a high level of functioning, whereas a high score for the \[symptom scales and/or single items\] represents a high level of symptomatology or problems.
Time frame: Up to the time of discharge (assessed up to 4 days)
Quality of Life in endometrial cancer
The Endometrial Cancer Module (QLQ-EN24) is a supplementary questionnaire module designed for patients with all stages of endometrial cancer and should always be employed in conjunction with the QLQ-C30. The QLQ-EN24 incorporates 5 multi-item scales to assess lymphoedema, urological symptoms, gastrointestinal symptoms, body image and sexual/vaginal problems. In addition, 8 single items assess pain in back and pelvis, tingling/numbness, muscular pain, hair loss, taste change, sexual interest, sexual activity and sexual enjoyment. The scoring approach for the QLQ-EN24 is identical in principle to that for the symptom scales/single-items of the QLQ-C30. Interpretation: All of the scales and single-item measures range in score from 0 to 100. A high score for the functional items represents a high level of functioning, whereas a high score for the symptom scales and single-items represents a high level of symptomatology or problems.
Time frame: Up to the time of discharge (assessed up to 4 days)
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