Gynaecological CancerNCT06713122
Effects of Symptom Management Education With Mobile Application in Gynecological Cancer Patients Receiving Chemotherapy
A study testing İntervention Group- Group receiving Symptom Management Training with Mobile Application in people with Gynaecological Cancer and Chemotherapy, run by Esra Nur Erdoğan at 1 site in Turkey (Türkiye).
Trial summary
Gynaecological cancers, which have an important place among the cancers seen both in the world and in our country. Chemotherapy, which is one of the most commonly used and basic methods in cancer treatment, causes many physical and psychological side effects while treating the disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynaecological Cancer, Chemotherapy, Nursing Care
- What is being tested?
- İntervention Group- Group receiving Symptom Management Training with Mobile Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 2 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving chemotherapy for the first time due to gynaecological cancer and completing the first chemotherapy course
- At least 18 years old
- Not previously diagnosed with cancer, diagnosed with gynaecological cancer for the first time and only
- Literate
- Who agreed to participate in the research
- No communication barrier
Show all 9Show fewer
- Eastern Cooperative Oncology Group (ECOG) Performance Scale score below 3
- No diagnosed psychiatric illness
- Women who have an Android or IOS smartphone and can access the internet
Who cannot join
- The investigator discontinued the treatment
- Chemotherapy treatment discontinued after the start of the study
- Not actively using the mobile application
- Not filling in the forms during the use of the Mobile Application
- The occurrence of another cancer during the research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Etlik City Hospital-Oncology Hospital-Day Outpatient Unit
Ankara
About this study
Official title: The Effect of Symptom Management Training Given to Gynaecological Cancer Patients Receiving Chemotherapy With Artificial Intelligence Supported Mobile Application on Supportive Care Needs, Symptom Severity and Psychological Well-Being
Gynaecological cancers, which have an important place among the cancers seen both in the world and in our country. Chemotherapy, which is one of the most commonly used and basic methods in cancer treatment, causes many physical and psychological side effects while treating the disease. It is very important to identify the symptoms experienced, evaluate, control and provide professional health guidance.
The spread of digitalisation has turned mobile learning into a kind of need or necessity rather than a preference. Increases the control of individuals over themselves and provides self-discipline.
Read more
The aim of this study was to evaluate the effect of symptom management training given with an artificial intelligence supported mobile application on supportive care needs, symptom severity and psychological well-being of gynaecological cancer patients receiving chemotherapy.
The study was planned as a randomised controlled trial. The population of the study will consist of patients who applied to Etlik City Hospital-Oncology Hospital-Day Outpatient Unit for the first time to receive chemotherapy treatment for gynaecological cancer and completed the first course.
The study will be conducted with a total of 70 patients, including 35 patients from the intervention group and 35 patients from the control group.
Research Hypotheses:
Gynaecological cancer patients receiving chemotherapyBetween the intervention group receiving symptom management training with a mobile application and the control group receiving standard care;
- H1: There is a difference in terms of the severity of symptoms experienced.
- H2: There is a difference in terms of supportive care needs.
- H3: There is a difference in terms of psychological well-being levels. Data Collection Tools Descriptive Information Form, Edmonton Symptom Diagnostic Scale, Supportive Care Needs Scale, Psychological Well-Being Scale and Eastern Cooperative Oncology Group (ECOG) Performance Scale will be used as data collection tools.
Modules to be included in the Mobile Application:
The forms will be administered a total of three times, initially at the end of the 3rd and 5th cycle.
Module 1: Introducing Module Module 2: Application Usage Instruction Module Module 3: Recognise the Disease Module Module 4: Common Symptoms and Recommendations During Chemotherapy Treatment Module Module 5: Let's Fight Symptoms Together Module Module 6: Ask Anything - Counselling Module
Read the detailed description
Gynaecological cancers, which have an important place among the cancers seen both in the world and in our country, are malignant tumours of the female reproductive organ. In the treatment of gynaecological cancers, many methods such as chemotherapy, radiotherapy, surgical treatment, hormone therapy are used alone or together. Chemotherapy, which is one of the most commonly used and basic methods in cancer treatment, causes many physical and psychological side effects while treating the disease. However, side effects may not occur at the same time and some may develop after discharge. Therefore, it is very important to identify the symptoms experienced, evaluate, control and provide professional health guidance.
The spread of digitalisation has turned mobile learning into a kind of need or necessity rather than a preference. The use of web-based platforms in disease management leads to effective communication between the patient and the healthcare team. Thanks to the use of a web-based platform, communication between the patient and the caregiver increases, saving time and reducing costs. In addition to the benefits such as the ability of the health professional to plan the treatment planning by incorporating the patient's experiences, needs and concerns into the process and providing the benefit of access without spatial limitations, it also increases the control of individuals over themselves and provides self-discipline.
The aim of this study is to evaluate the effect of symptom management training given with an artificial intelligence supported mobile application developed for gynaecological cancer patients receiving chemotherapy on supportive care needs, symptom severity and psychological well-being.
The study was planned as a randomised controlled trial. Block randomisation will be used to assign patients to intervention and control groups.
The population of the study will consist of patients who applied to Etlik City Hospital-Oncology Hospital-Day Outpatient Unit for the first time to receive chemotherapy treatment for gynaecological cancer and completed the first course.
The sample of the study will consist of patients who applied to Etlik City Hospital-Oncology Hospital-Day Outpatient Unit to receive chemotherapy treatment for the first time and who meet the following inclusion criteria.
The study will be conducted with a total of 70 patients, including 35 patients from the intervention group and 35 patients from the control group (The sample number of the study was calculated by using the G Power programme using the data of a study in which mobile application intervention was carried out on cancer patients. Accordingly, the confidence interval was 95%; the margin of error was accepted as 5% and a total of 56 patients were found as 28 intervention and 28 control group. Considering that there may be losses during the mobile application intervention, the sample number was kept 25% higher than the calculated sample number.)
Research Hypotheses:
Gynaecological cancer patients receiving chemotherapyBetween the intervention group receiving symptom management training with a mobile application and the control group receiving standard care;
- H1: There is a difference in terms of the severity of symptoms experienced.
- H2: There is a difference in terms of supportive care needs.
- H3: There is a difference in terms of psychological well-being levels. Data Collection Tools Descriptive Information Form, Edmonton Symptom Diagnostic Scale, Supportive Care Needs Scale, Psychological Well-Being Scale and Eastern Cooperative Oncology Group (ECOG) Performance Scale will be used as data collection tools.
- Data collection tools will be sent to patients via the application and will be asked to be filled in.
Modules to be included in the Mobile Application:
- The application will include module, registration, login and profile creation sections.
- The intervention group will be able to give feedback as they use the application.
- Motivational messages will be sent.
- At the end of the study, the mobile application will also be open to the control group.
- The forms will be administered a total of three times, initially at the end of the 3rd and 5th cycle.
- Module 1: Introducing Module
- Module 2: Application Usage Instruction Module
- Module 3: Recognise the Disease Module
- Module 4: Common Symptoms and Recommendations During Chemotherapy Treatment Module
- Module 5: Let's Fight Symptoms Together Module
- Module 6: Ask Anything - Counselling Module
- Conditions
- Gynaecological Cancer, Chemotherapy, Nursing Care
- Being tested
- İntervention Group- Group receiving Symptom Management Training with Mobile Application
- Keywords
- Gynaecological cancer, chemotherapy, mobile application, nursing care, psychological well-being, supportive care needs
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
İntervention Group- Group receiving Symptom Management Training with Mobile ApplicationBehavioural
The application to be developed in the research will be both Android and IOS supported.
Monitoring the active use of the patients from the interface by the researcher and receiving individual and collective notifications in line with the profile that the patients receiving chemotherapy will create in the application will increase the usability of the application. Thus, the benefit that users receive after active use can be determined.
The content of the Let's fight the symptoms together module will be created by experts in the field and people will be able to actively use these methods while struggling with the symptoms they experience.
Patients may not always have the opportunity to reach a nurse or health professional. In symptom management with the mobile application, artificial intelligence will be trained by the researcher and integrated into the application will help patients reach the right information without wasting time.
| Study group | Role | What they receive |
|---|---|---|
| İntervention Group- Group receiving Symptom Management Training with Mobile Application | Experimental | Mobile application intervention will be applied to the intervention group. The evaluation tests will be repeated after the first cycle of chemotherapy treatment, at the 3rd and 5th cycles. Receives: Behavioral: İntervention Group- Group receiving Symptom Management Training with Mobile Application |
| Control Group | No intervention | No intervention will be applied to the control group. The evaluation tests will be repeated after the first cycle of chemotherapy treatment, at the 3rd and 5th cycles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supportive Care Needs
Supportive Care Needs Scale:Each question in the scale is numbered from 1 to 5 and 1 point corresponds to 'I did not experience this situation' and 5 points correspond to 'I needed a lot of support'
Measured: Evaluation test: will be performed after the first cycle of chemotherapy treatment and after the 3rd and 5th cycles (each cycle is 28 days)
Symptom Severity
Edmonton Symptom Diagnostic Scale: The severity of each symptom is assessed with numerical numbers from 0 to 10. A score of 0 indicates that the symptom is absent and a score of 10 indicates that the symptom is felt very severely.
Measured: Evaluation test: will be performed after the first cycle of chemotherapy treatment and after the 3rd and 5th cycles (each cycle is 28 days)
Psychological Well-Being
Psychological Well-Being Scale: The items of the Psychological Well-Being Scale are answered between 1-7 in the form of strongly disagree (1) and strongly agree (7). Scores vary between 8 and 56. A high score indicates that the person has many psychological resources and strengths.
Measured: Evaluation test: will be performed after the first cycle of chemotherapy treatment and after the 3rd and 5th cycles (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion2 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynaecological CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esra Nur Erdoğan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Esra Nur Erdoğan, Saglik Bilimleri Universitesi
- Investigators
- Esra Nur Erdoğan, PhD Student, Study chair, University of Health Sciences Gulhane Faculty of Nursing, Department of Obstetrics and GynaecologyGülten Güvenç, Prof.Dr., Principal investigator, University of Health Sciences Gulhane Faculty of Nursing, Department of Obstetrics and GynaecologyTülay Eren, Asst. Prof., Study chair, Etlik City Hospital, Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713122
- Sponsor's protocol ID
- 2024-442
- Status last verified
- Dec 2024
- First submitted
- 10 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the end of the study: study protocol and Clinical Study Report (CSR)
Publications
Graetz I, Anderson JN, McKillop CN, Stepanski EJ, Paladino AJ, Tillmanns TD. Use of a web-based app to improve postoperative outcomes for patients receiving gynecological oncology care: A randomized controlled feasibility trial. Gynecol Oncol. 2018 Aug;150(2):311-317. doi: 10.1016/j.ygyno.2018.06.007. Epub 2018 Jun 11.
PubMed 29903391
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Symptom Management Training Given to Gynaecological Cancer Patients Receiving Chemotherapy With Artificial Intelligence Supported Mobile Application on Supportive Care Needs, Symptom Severity and Psychological Well-Being
- ClinicalTrials.gov ID
- NCT06713122
- Acronym / sponsor ID
- 2024-442
- Conditions
- Gynaecological Cancer, Chemotherapy, Nursing Care
- Keywords
- Gynaecological cancer, chemotherapy, mobile application, nursing care, psychological well-being, supportive care needs
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Esra Nur ErdoğanUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 2 Feb 2026 (estimated)
- First posted
- 3 Dec 2024 (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.
Gynaecological cancers, which have an important place among the cancers seen both in the world and in our country. Chemotherapy, which is one of the most commonly used and basic methods in cancer treatment, causes many physical and psychological side effects while treating the disease. It is very important to identify the symptoms experienced, evaluate, control and provide professional health guidance.
The spread of digitalisation has turned mobile learning into a kind of need or necessity rather than a preference. Increases the control of individuals over themselves and provides self-discipline.
The aim of this study was to evaluate the effect of symptom management training given with an artificial intelligence supported mobile application on supportive care needs, symptom severity and psychological well-being of gynaecological cancer patients receiving chemotherapy.
The study was planned as a randomised controlled trial. The population of the study will consist of patients who applied to Etlik City Hospital-Oncology Hospital-Day Outpatient Unit for the first time to receive chemotherapy treatment for gynaecological cancer and completed the first course.
The study will be conducted with a total of 70 patients, including 35 patients from the intervention group and 35 patients from the control group.
Research Hypotheses:
Gynaecological cancer patients receiving chemotherapyBetween the intervention group receiving symptom management training with a mobile application and the control group receiving standard care;
- H1: There is a difference in terms of the severity of symptoms experienced.
- H2: There is a difference in terms of supportive care needs.
- H3: There is a difference in terms of psychological well-being levels. Data Collection Tools Descriptive Information Form, Edmonton Symptom Diagnostic Scale, Supportive Care Needs Scale, Psychological Well-Being Scale and Eastern Cooperative Oncology Group (ECOG) Performance Scale will be used as data collection tools.
Modules to be included in the Mobile Application:
The forms will be administered a total of three times, initially at the end of the 3rd and 5th cycle.
Module 1: Introducing Module Module 2: Application Usage Instruction Module Module 3: Recognise the Disease Module Module 4: Common Symptoms and Recommendations During Chemotherapy Treatment Module Module 5: Let's Fight Symptoms Together Module Module 6: Ask Anything - Counselling Module
Detailed description
Gynaecological cancers, which have an important place among the cancers seen both in the world and in our country, are malignant tumours of the female reproductive organ. In the treatment of gynaecological cancers, many methods such as chemotherapy, radiotherapy, surgical treatment, hormone therapy are used alone or together. Chemotherapy, which is one of the most commonly used and basic methods in cancer treatment, causes many physical and psychological side effects while treating the disease. However, side effects may not occur at the same time and some may develop after discharge. Therefore, it is very important to identify the symptoms experienced, evaluate, control and provide professional health guidance.
The spread of digitalisation has turned mobile learning into a kind of need or necessity rather than a preference. The use of web-based platforms in disease management leads to effective communication between the patient and the healthcare team. Thanks to the use of a web-based platform, communication between the patient and the caregiver increases, saving time and reducing costs. In addition to the benefits such as the ability of the health professional to plan the treatment planning by incorporating the patient's experiences, needs and concerns into the process and providing the benefit of access without spatial limitations, it also increases the control of individuals over themselves and provides self-discipline.
The aim of this study is to evaluate the effect of symptom management training given with an artificial intelligence supported mobile application developed for gynaecological cancer patients receiving chemotherapy on supportive care needs, symptom severity and psychological well-being.
The study was planned as a randomised controlled trial. Block randomisation will be used to assign patients to intervention and control groups.
The population of the study will consist of patients who applied to Etlik City Hospital-Oncology Hospital-Day Outpatient Unit for the first time to receive chemotherapy treatment for gynaecological cancer and completed the first course.
The sample of the study will consist of patients who applied to Etlik City Hospital-Oncology Hospital-Day Outpatient Unit to receive chemotherapy treatment for the first time and who meet the following inclusion criteria.
The study will be conducted with a total of 70 patients, including 35 patients from the intervention group and 35 patients from the control group (The sample number of the study was calculated by using the G Power programme using the data of a study in which mobile application intervention was carried out on cancer patients. Accordingly, the confidence interval was 95%; the margin of error was accepted as 5% and a total of 56 patients were found as 28 intervention and 28 control group. Considering that there may be losses during the mobile application intervention, the sample number was kept 25% higher than the calculated sample number.)
Research Hypotheses:
Gynaecological cancer patients receiving chemotherapyBetween the intervention group receiving symptom management training with a mobile application and the control group receiving standard care;
- H1: There is a difference in terms of the severity of symptoms experienced.
- H2: There is a difference in terms of supportive care needs.
- H3: There is a difference in terms of psychological well-being levels. Data Collection Tools Descriptive Information Form, Edmonton Symptom Diagnostic Scale, Supportive Care Needs Scale, Psychological Well-Being Scale and Eastern Cooperative Oncology Group (ECOG) Performance Scale will be used as data collection tools.
- Data collection tools will be sent to patients via the application and will be asked to be filled in.
Modules to be included in the Mobile Application:
- The application will include module, registration, login and profile creation sections.
- The intervention group will be able to give feedback as they use the application.
- Motivational messages will be sent.
- At the end of the study, the mobile application will also be open to the control group.
- The forms will be administered a total of three times, initially at the end of the 3rd and 5th cycle.
- Module 1: Introducing Module
- Module 2: Application Usage Instruction Module
- Module 3: Recognise the Disease Module
- Module 4: Common Symptoms and Recommendations During Chemotherapy Treatment Module
- Module 5: Let's Fight Symptoms Together Module
- Module 6: Ask Anything - Counselling Module
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İntervention Group- Group receiving Symptom Management Training with Mobile Application | Experimental | Behavioral: İntervention Group- Group receiving Symptom Management Training with Mobile ApplicationMobile application intervention will be applied to the intervention group. The evaluation tests will be repeated after the first cycle of chemotherapy treatment, at the 3rd and 5th cycles. |
| Control Group | No intervention | –No intervention will be applied to the control group. The evaluation tests will be repeated after the first cycle of chemotherapy treatment, at the 3rd and 5th cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Receiving chemotherapy for the first time due to gynaecological cancer and completing the first chemotherapy course
- At least 18 years old
- Not previously diagnosed with cancer, diagnosed with gynaecological cancer for the first time and only
- Literate
- Who agreed to participate in the research
Key exclusion criteria (5 listed)
- The investigator discontinued the treatment
- Chemotherapy treatment discontinued after the start of the study
- Not actively using the mobile application
- Not filling in the forms during the use of the Mobile Application
- The occurrence of another cancer during the research
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 |
|---|---|---|
| İntervention Group- Group receiving Symptom Management Training with Mobile ApplicationThe application to be developed in the research will be both Android and IOS supported. Monitoring the active use of the patients from the interface by the researcher and receiving individual and collective notifications in line with the profile that the patients receiving chemotherapy will create in the application will increase the usability of the application. Thus, the benefit that users receive after active use can be determined. The content of the Let's fight the symptoms together module will be created by experts in the field and people will be able to actively use these methods while struggling with the symptoms they experience. Patients may not always have the opportunity to reach a nurse or health professional. In symptom management with the mobile application, artificial intelligence will be trained by the researcher and integrated into the application will help patients reach the right information without wasting time. | Behavioural | İntervention Group- Group receiving Symptom Management Training with Mobile Application |
Primary outcome
Supportive Care Needs
Time frame: Evaluation test: will be performed after the first cycle of chemotherapy treatment and after the 3rd and 5th cycles (each cycle is 28 days)
Supportive Care Needs Scale:Each question in the scale is numbered from 1 to 5 and 1 point corresponds to 'I did not experience this situation' and 5 points correspond to 'I needed a lot of support'
Symptom Severity
Time frame: Evaluation test: will be performed after the first cycle of chemotherapy treatment and after the 3rd and 5th cycles (each cycle is 28 days)
Edmonton Symptom Diagnostic Scale: The severity of each symptom is assessed with numerical numbers from 0 to 10. A score of 0 indicates that the symptom is absent and a score of 10 indicates that the symptom is felt very severely.
Psychological Well-Being
Time frame: Evaluation test: will be performed after the first cycle of chemotherapy treatment and after the 3rd and 5th cycles (each cycle is 28 days)
Psychological Well-Being Scale: The items of the Psychological Well-Being Scale are answered between 1-7 in the form of strongly disagree (1) and strongly agree (7). Scores vary between 8 and 56. A high score indicates that the person has many psychological resources and strengths.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Background: PubMed 29903391Graetz I, Anderson JN, McKillop CN, Stepanski EJ, Paladino AJ, Tillmanns TD. Use of a web-based app to improve postoperative outcomes for patients receiving gynecological oncology care: A randomized controlled feasibility trial. Gynecol Oncol. 2018 Aug;150(2):311-317. doi: 10.1016/j.ygyno.2018.06.007. Epub 2018 Jun 11.
- Individual participant dataSharing planned: Yes. After the end of the study: study protocol and Clinical Study Report (CSR)
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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.
Esra Nur Erdoğan, PhD Student study chair
University of Health Sciences Gulhane Faculty of Nursing, Department of Obstetrics and Gynaecology
Gülten Güvenç, Prof.Dr. principal investigator
University of Health Sciences Gulhane Faculty of Nursing, Department of Obstetrics and Gynaecology
Tülay Eren, Asst. Prof. study chair
Etlik City Hospital, Medical Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing İntervention Group- Group receiving Symptom Management Training with Mobile Application in people with Gynaecological Cancer and Chemotherapy, run by Esra Nur Erdoğan 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 9 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 3 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Supportive Care Needs (time frame: Evaluation test: will be performed after the first cycle of chemotherapy treatment and after the 3rd and 5th cycles (each cycle is 28 days)). 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?
On the ClinicalTrials.gov record for NCT06713122, which also lists 1 linked publication.
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 3 Dec 2024.