Gynecologic CancerNCT06176274
Pre-Operative Prehabilitation Program Women With Gynecological Cancer
A study testing Prehabilition program in people with Gynecologic Cancer and Prehabilitation, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Cancer, Prehabilitation
- What is being tested?
- Prehabilition program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Nov 2024
- 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 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof Dr Cemil Taşçıoğlu City Hospital
Istanbul, 34400
800-525-5552
hilal evgin, Phd Student
About this study
Official title: The Effect of Pre-Operative Prehabilitation Program on Postoperative Recovery in Women With Gynecological Cancer
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.
Read the 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
- Conditions
- Gynecologic Cancer, Prehabilitation
- Being tested
- Prehabilition program
- Keywords
- Prehabilitation, cancer, Gynecologic cancer, nursing
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilition programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| the experimental group | Experimental | a prehabilitation program will be applied before the surgery. Receives: Other: Prehabilition program |
| The Control Group | No intervention | he will receive standard nursing care procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
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).
Measured: 10 weeks
day of hospital stay
the length of hospital stay
Measured: 1 weeks
the WHODASS proficiency scale
the WHODASS proficiency scale will be used. It is useful for a brief assessment of the overall functionality.
Measured: 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomized trial with experimental design with pre-test post-test control group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Evgin, Istanbul University - Cerrahpasa
- Investigators
- hilal Evgin, Phd Student, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176274
- Sponsor's protocol ID
- IstanbulUC-LEE-HE-01
- Status last verified
- Jun 2023
- First submitted
- 10 Dec 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- 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 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-Operative Prehabilitation Program on Postoperative Recovery in Women With Gynecological Cancer
- ClinicalTrials.gov ID
- NCT06176274
- Acronym / sponsor ID
- IstanbulUC-LEE-HE-01
- Conditions
- Gynecologic Cancer, Prehabilitation
- Keywords
- Prehabilitation, cancer, Gynecologic cancer, nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 19 Dec 2023 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- a randomized trial with experimental design with pre-test post-test control group
| Arm | Type | Receives |
|---|---|---|
| the experimental group | Experimental | Other: Prehabilition programa prehabilitation program will be applied before the surgery. |
| The Control Group | No intervention | –he will receive standard nursing care procedure. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Prehabilition programthis 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. | Other | the experimental group |
Primary outcome
the Quality of Recovery QoR-15
Time frame: 6 weeks
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.
functional capacity 6MWT
Time frame: 10 weeks
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).
day of hospital stay
Time frame: 1 weeks
the length of hospital stay
the WHODASS proficiency scale
Time frame: 1 weeks
the WHODASS proficiency scale will be used. It is useful for a brief assessment of the overall functionality.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- 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.
hilal Evgin, Phd Student principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilition program in people with Gynecologic Cancer and Prehabilitation, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Dec 2023. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hilal EVGİN, Phd Student (800-525-5552, hilalevgin.94@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Quality of Recovery QoR-15 (time frame: 6 weeks). The study lists 4 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 19 Dec 2023.