Gynecologic Oncology PatientNCT07188662
Multimodal Prehabilitation Program for Women Undergoing Gynecologic Oncology Surgery
A study testing group (B) Prehabilitation care combine with ERAS post-operative care in people with Gynecologic Oncology Patient, run by Assiut University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the role of multimodal Prehabilitation program on improve surgical outcomes after gynecological oncology surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Gynecologic Oncology Patient
- What is being tested?
- group (B) Prehabilitation care combine with ERAS post-operative care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Apr 2024to 23 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed woman with gynecologic cancer by imaging \&histopathology
- Accept participation in the study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Multimodal Prehabilitation Program in Improving Surgical Outcomes for Women Undergoing Gynecologic Oncology Surgery
The goal of this clinical trial is to evaluate the role of multimodal Prehabilitation program on improve surgical outcomes after gynecological oncology surgery.
Read the 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.
- Conditions
- Gynecologic Oncology Patient
- Being tested
- group (B) Prehabilitation care combine with ERAS post-operative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group (B) Prehabilitation care combine with ERAS post-operative careProcedure or surgery
intervention will includes receiving prehabilitation care combine with ERAS post-operative care.
| Study group | Role | What they receive |
|---|---|---|
| Conventional group | No intervention | Conventional group (woman received hospital care at previous year as a retrospective sample to prevent risk of bias) equal 70 woman |
| Prehabilitation group | Experimental | Prehabilitation group (woman who will receive prehabilitation care combine with ERAS post-operative care as a prospective sample) equal 70 woman Receives: Procedure: group (B) Prehabilitation care combine with ERAS post-operative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
changing the postoperative morbidity
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.)
Measured: "up to 30 days postoperative"
changing the postoperative mortality
compare the 30 days postoperative mortality of the prehabilitation group and conventional group.
Measured: "up to 30 days postoperative"
Pain intensity measured by the Visual Analog Scale (VAS) for pain.
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.
Measured: "up to 30 days postoperative"
Secondary outcomes (9)
change the length of the hospital stay
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).
Measured: up to 5 days post-operative
Enhance the physical state of gynecological oncology patient using the Eastern Cooperative Oncology Group (ECOG)
- 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.
Measured: through the postoperative period within two hours up-to 30 days after surgery
Enhance the psychological wellbeing of gynecological oncology patient
- 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
Measured: up-to 15 days preoperatively & up to 30 days post operatively]
assess and changing the Nutritional Status of the prehabilitation group
Nutritional Status measured through the following:
- Nutritional Status - Height/m Description: Patient height measured in meters.
- Nutritional Status - Weight/kg Description: Patient body weight measured in kilograms.
- weight and height combined to report BMI in kg/m^2
Measured: up-to 30 days postoperative
assess and changing the Nutritional Status of the prehabilitation group
Nutritional Status measured through:
- Clinical Signs using Patient-Generated Subjective Global Assessment (PG-SGA): The PG-SGA is a subjective nutritional assessment tool used in oncology; include questions about:
- Weight change (past 1 month and 6 months (increased 0 or decreased 1
- Eating patterns changed over last weeks or months (normal, less than normal, only liquids, very little, etc.)
- Gastrointestinal Symptoms affecting intake (e.g., nausea, vomiting ,pain, diarrhea, etc.)
- Functional capacity\& activity (normal activity, reduced, bed/chair bound, etc.) Scoring system of PG-SGA: A)Well-nourished (0-3) B)Moderately malnourished 4-8 C)Severely malnourished more then >9
Measured: up-to 30 days postoperative
improve the Cardiopulmonary fitness of gynecological oncology patient after surgery
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 .
Measured: up-to 15 days preoperatively & up to 30 days post operatively]
improve the Cardiopulmonary fitness of gynecological oncology patient after surgery
Cardiopulmonary Fitness measured by use of:
- VO2max (calculated): Estimated VO2max in mL/kg/min using the predictive equation from 6MWT distance and BMI.
- Time Frame: up to 30 postoperatively
- Unit of Measure: mL/kg/min.
Measured: up-to 15 days preoperatively & up to 30 days post operatively]
improve the Cardiopulmonary fitness of gynecological oncology patient after surgery
Cardiopulmonary Fitness measured by use of:
- Fatigue - Visual Analog Scale (VAS) for Fatigue
- Time Frame: Up to 15 days preoperatively -operative.
- Unit of Measure: Units on a scale (0-10 cm).
- Scale: 0 = no fatigue, 10 = worst fatigue imaginable; higher scores indicate worse fatigue.
Measured: up-to 15 days preoperatively & up to 30 days post operatively]
improve the Cardiopulmonary fitness of gynecological oncology patient after surgery
Cardiopulmonary Fitness measured by use of:
- Dyspnea - Visual Analog Scale (VAS) for Dyspnea
- Description: Breathlessness severity measured by VAS.
- Time Frame: Up to 15 days post-operative.
- Unit of Measure: Units on a scale (0-10 cm).
- Scale: 0 = no breathlessness, 10 = worst breathlessness imaginable; higher scores indicate worse dyspnea.
Measured: up-to 15 days preoperatively & up to 30 days post operatively]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start23 Apr 2024
- Primary completion23 Apr 2025
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic Oncology PatientStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya M. Abdelhafez, Assiut University
- Investigators
- Aziza M Mohammed, Head nurse, Study chair, Woman's Health Hospital, Assiut University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188662
- Sponsor's protocol ID
- MMPPGOS
- Status last verified
- Sep 2025
- First submitted
- 11 Jul 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Multimodal Prehabilitation Program in Improving Surgical Outcomes for Women Undergoing Gynecologic Oncology Surgery
- ClinicalTrials.gov ID
- NCT07188662
- Acronym / sponsor ID
- MMPPGOS
- Conditions
- Gynecologic Oncology Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional group | No intervention | –Conventional group (woman received hospital care at previous year as a retrospective sample to prevent risk of bias) equal 70 woman |
| Prehabilitation group | Experimental | Procedure: group (B) Prehabilitation care combine with ERAS post-operative carePrehabilitation group (woman who will receive prehabilitation care combine with ERAS post-operative care as a prospective sample) equal 70 woman |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosed woman with gynecologic cancer by imaging \&histopathology
- Accept participation in the study.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| group (B) Prehabilitation care combine with ERAS post-operative careintervention will includes receiving prehabilitation care combine with ERAS post-operative care. | Procedure or surgery | Prehabilitation group |
Primary outcome
changing the postoperative morbidity
Time frame: "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
Time frame: "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.
Time frame: "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.
9 secondary outcomes
change the length of the hospital stay
Time frame: up to 5 days post-operative
Enhance the physical state of gynecological oncology patient using the Eastern Cooperative Oncology Group (ECOG)
Time frame: through the postoperative period within two hours up-to 30 days after surgery
Enhance the psychological wellbeing of gynecological oncology patient
Time frame: up-to 15 days preoperatively & up to 30 days post operatively]
assess and changing the Nutritional Status of the prehabilitation group
Time frame: up-to 30 days postoperative
assess and changing the Nutritional Status of the prehabilitation group
Time frame: up-to 30 days postoperative
improve the Cardiopulmonary fitness of gynecological oncology patient after surgery
Time frame: up-to 15 days preoperatively & up to 30 days post operatively]
improve the Cardiopulmonary fitness of gynecological oncology patient after surgery
Time frame: up-to 15 days preoperatively & up to 30 days post operatively]
improve the Cardiopulmonary fitness of gynecological oncology patient after surgery
Time frame: up-to 15 days preoperatively & up to 30 days post operatively]
improve the Cardiopulmonary fitness of gynecological oncology patient after surgery
Time frame: up-to 15 days preoperatively & up to 30 days post operatively]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aziza M Mohammed, Head nurse study chair
Woman's Health Hospital, Assiut University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group (B) Prehabilitation care combine with ERAS post-operative care in people with Gynecologic Oncology Patient, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changing the postoperative morbidity (time frame: "up to 30 days postoperative"). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.