Gynecologic CancerNCT05131490
Effect on Adaptation to Cancer of Mobile Application Developed for Gynecological Cancer Patients
A study testing A mobile application intervention developed for gynecological cancer patients receiving chemotherapy in people with Gynecologic Cancer and Chemotherapy Effect, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Getting a cancer diagnosis, the difficult treatments applied and the side effects that occur completely affect the life of the patient, shaking his future plans and adaptation mechanisms. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer, Chemotherapy Effect, Mobile Application
- What is being tested?
- A mobile application intervention developed for gynecological cancer patients receiving chemotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2022to 15 Feb 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be over 18 years old
- Be at least primary school graduate
- Volunteering to participate in research
- Being diagnosed with gynecological cancer for the first time (no cancer recurrence)
- Receiving at least one course of chemotherapy and continuing chemotherapy treatment
- Be Eastern Cooperative Oncology Group (ECOG) performance scale score below 3
Show all 9Show fewer
- Be not have a psychiatric illness
- Owning a smartphone
- Be have internet access and have used any mobile application before
Who cannot join
- Be have any psychiatric illness
- Be have not yet received or completed chemotherapy treatment
- Be Eastern Cooperative Oncology Group (ECOG) performance scale score of 3 and above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect on Physical and Psychosocial Adaptation of Mobile Application Developed for Gynecological Cancer Patients Receiving Chemotherapy
Getting a cancer diagnosis, the difficult treatments applied and the side effects that occur completely affect the life of the patient, shaking his future plans and adaptation mechanisms. In recent years, the role of healthcare professionals has included counseling and promoting positive health behaviors to reduce disease and treatment side effects and increase adherence to disease. The service provided by healthcare professionals to patients has started to move to digital environments with the developing technology and the concept of e-health has been born. Offering e-health support as part of regular care has become a powerful tool to help cancer patients manage their disease. Web-based interventions or mobile applications provide an opportunity for improved communication and better information exchange between healthcare professionals and patients. In addition, education of cancer patients and patient self-management allow for better clinical outcomes using e-health or mobile health applications. The widespread use of smartphones enables cancer patients to be supported from different perspectives through mobile applications. When the studies are examined, it is noteworthy that mobile applications developed for female cancer patients are predominantly related to breast cancer. Most of the technology-based researches on gynecological cancers are studies conducted through text message intervention, online web-based interventions or social media tools such as Facebook and WeChat. For this reason, the aim of this study is to develop a mobile application to increase physical and psychosocial adjustment for gynecological cancer patients receiving chemotherapy and to investigate its effectiveness.
Read the detailed description
This study was planned as a parallel, single-blind, pre-post-test randomized controlled experimental study in which two groups (experiment-control) will be compared. The block randomization method will be used. The patients who will participate in the research will be reached through social media networks related to cancer (Facebook and Instagram account of the Dance with Cancer Association, etc.) and the data will be collected from patients who are suitable for the sample characteristics through mobile application. The sample size was calculated in the G*power statistics program by utilizing the data of a study in which on cancer patients using a mobile application intervention was previously performed (α =0.05, d=0.75). Accordingly, it was found that 23 people should be taken for each group to sampling for 80% power. Considering that there might be losses, the number of samples was increased by 10% and it was planned to include a total of 52 people in the study. Intention-to-treat analysis will be performed to manage bias and losses.
A pilot application will be conducted for 4 weeks with 6 patients regarding the usability of the mobile application and these patients will not be included in the study. At the end of 4 weeks, feedback will be received from the patients participating in the pilot application with the mobile application evaluation form. Necessary changes will be made in the mobile application in line with the feedback.
- Conditions
- Gynecologic Cancer, Chemotherapy Effect, Mobile Application, Physiological Adaptation, Psychosocial Adaptation
- Being tested
- A mobile application intervention developed for gynecological cancer patients receiving chemotherapy
- Keywords
- Gynecologic Cancer, Chemotherapy Effect, Mobile Application, Physiological Adaptation, Psychosocial Adaptation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A mobile application intervention developed for gynecological cancer patients receiving chemotherapyBehavioural
The mobile application will consist of modules. It is planned to include four education modules and consultancy modules in the application.
- Module 1: It will consist of sub-categories with information to be prepared in line with the current literature on gynecological cancer types and treatments applied. There will be information and short videos that will strengthen coping with physical symptoms, especially from chemotherapy.
- Module 2: In this area, there will be meditation and relaxation/breathing exercises, information on relaxing complementary therapies, anxiety reduction and stress management techniques videos and audio recordings.
- Module 3: Current developments on gynecological cancers will be included.
- Module 4: Encouraging recovery stories and videos of cancer survivors will be included.
- Module 5: Counseling module. This is the area where patients who cannot find answers in the frequently asked questions section can ask questions to the research team.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Experimental group intervention consists two months a mobile application intervention developed for gynecological cancer patients receiving chemotherapy Receives: Behavioral: A mobile application intervention developed for gynecological cancer patients receiving chemotherapy |
| No intervention | No intervention | Control group receive routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Psychosocial Adjustment to İllnes Scale-Self Report (PAIS-SR)
The scale measures the interaction of individuals with other individuals and institutions forming the socio-cultural environment and consists of 7 sub-dimensions. These; Health Care Orientation (8 items); Vocational Environment (6 items); Domestic Environment (8 items); Sexual Relationship (6 items); extended family relationships (5 items); social environment (6 items); psychological pressure (7 items) it consists of 46 items in total, including. It is calculated by giving scores ranging from 0 to 3 for the items in the scale. Major negative changes since illness are scored with 3 points, no change or positive changes with 0 points. A score below 35 indicates "good psychosocial adjustment", a score between 35 and 51 indicates "moderately good psychosocial adjustment", and a score above 51 indicates "poor psychosocial adjustment". An increase in the score is an indication of difficulty in adaptation and deterioration.
Measured: Change from baseline PAIS-SR score at 4 and 8 weeks
MD Anderson Symptom Inventory (MDASI)
It is a short inventory that measures the impact and severity of cancer-related symptoms. Each symptom is evaluated at 11 levels (0=no symptoms, 10=very bad).
The scale consists of two sub-dimensions and 19 items. In the first part of the inventory, "symptoms" (13 items), in the second part "inhibition of the individual's life" (6 items) and the situation in the last 24 hours are evaluated. In the event that the life of the individual in the second part of the inventory is hindered; general activity, mood, work and/or works in home, relationships with other people, walking, enjoying life are evaluated. A high score indicates an increase in the severity of the symptom and a negative impact on life.
Measured: Change from baseline MDASI score at 4 and 8 weeks
Hospital Anxiety and Depression Scale (HADS)
The aim of the scale is not to diagnose, but to determine the risk group by scanning anxiety and depression in a short time in patients with physical illness. The scale has anxiety (HADS-A) and depression (HADS-D) subscales. The scale is a self-report scale and consists of 14 items, 7 of which investigate symptoms of anxiety and 7 of which investigate symptoms of depression. Responses are evaluated on a four-point Likert scale and scored between 0-3. Odd numbers measure anxiety, even numbers measure depression.
For both subscales, "7 and below" non-patients, "8-10" borderline patients, and "11 and above" patient evaluations were deemed appropriate. The scoring of each item in the scale is different. Items 1, 3, 5, 6, 8, 10, 11, and 13 show decreasing severity and the scoring is 3, 2, 1, 0. On the other hand, the 2nd, 4th, 7th, 9th, 12th and 14th items are scored as 0, 1, 2, 3, respectively. The lowest score that can be obtained from both subscales is 0, and the highest score is 21.
Measured: Change from baseline HADS score at 4 and 8 weeks
Assessment of Survivor Concerns (ASC)
The scale was developed in 2007 to evaluate the fear of recurrence of cancer and general health in cancer patients. The scale has two subscales: "cancer worry subscale" and "general health worry subscale". The scale included six items and three in each subscale. However, as the sixth item was 'children's health worry"' which cannot be administered to those who have no children, the scale was revised, and this item was removed. The number of items was reduced to five. The new 5-item form of the scale is recommended. According to the revised scale, the "cancer worry subscale" is comprised of three items and the "general health scale" two items. The Assessment of Survivor Concerns Scale is a 4-point Likert type scale that is evaluated as "not at all" and "very much". The lowest score possible on this scale is five and the highest is 20. Higher scores indicate higher levels of concern.
Measured: Change from baseline ASC score at 4 and 8 weeks
Eastern Cooperative Oncology Group (ECOG) Performance Status
The ECOG Scale of Performance Status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). This numbering scale is one way to define the population of patients to be studied in the trial. The scale was developed by the Eastern Cooperative Oncology Group (ECOG), now part of the ECOG-ACRIN Cancer Research Group, and published in 1982. It is used to promote greater standardization among researchers who design and evaluate clinical cancer studies and to assess the general well-being of patients. A score between 0 and 5 is made.
Measured: Baseline
Mobile Application Evaluation Form
It is a form created by researchers to evaluate satisfaction with the use of the mobile application. With this form, after the "pilot application" from patients will receive feedback on the ease of use and content of the mobile application.
Measured: At the end of the 4-week pilot application
Introductory Information Form
It is the form that contains information about the socio-demographic characteristics of the patients diagnosed with gynecological cancer and the type, duration and stage of the diagnosed gynecological cancer, the treatments received and the number of chemotherapy cycles.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start15 Sep 2022
- Primary completion15 Dec 2022
- Study completion15 Feb 2023
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 Pamukkale 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blind pre-post test randomized controlled design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Okan Vardar, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131490
- Sponsor's protocol ID
- 60116787-020/34123
- Status last verified
- Feb 2023
- First submitted
- 12 Nov 2021
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Physical and Psychosocial Adaptation of Mobile Application Developed for Gynecological Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT05131490
- Acronym / sponsor ID
- 60116787-020/34123
- Conditions
- Gynecologic Cancer, Chemotherapy Effect, Mobile Application, Physiological Adaptation, Psychosocial Adaptation
- Keywords
- Gynecologic Cancer, Chemotherapy Effect, Mobile Application, Physiological Adaptation, Psychosocial Adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 23 Nov 2021 (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.
Getting a cancer diagnosis, the difficult treatments applied and the side effects that occur completely affect the life of the patient, shaking his future plans and adaptation mechanisms. In recent years, the role of healthcare professionals has included counseling and promoting positive health behaviors to reduce disease and treatment side effects and increase adherence to disease. The service provided by healthcare professionals to patients has started to move to digital environments with the developing technology and the concept of e-health has been born. Offering e-health support as part of regular care has become a powerful tool to help cancer patients manage their disease. Web-based interventions or mobile applications provide an opportunity for improved communication and better information exchange between healthcare professionals and patients. In addition, education of cancer patients and patient self-management allow for better clinical outcomes using e-health or mobile health applications. The widespread use of smartphones enables cancer patients to be supported from different perspectives through mobile applications. When the studies are examined, it is noteworthy that mobile applications developed for female cancer patients are predominantly related to breast cancer. Most of the technology-based researches on gynecological cancers are studies conducted through text message intervention, online web-based interventions or social media tools such as Facebook and WeChat. For this reason, the aim of this study is to develop a mobile application to increase physical and psychosocial adjustment for gynecological cancer patients receiving chemotherapy and to investigate its effectiveness.
Detailed description
This study was planned as a parallel, single-blind, pre-post-test randomized controlled experimental study in which two groups (experiment-control) will be compared. The block randomization method will be used. The patients who will participate in the research will be reached through social media networks related to cancer (Facebook and Instagram account of the Dance with Cancer Association, etc.) and the data will be collected from patients who are suitable for the sample characteristics through mobile application. The sample size was calculated in the G*power statistics program by utilizing the data of a study in which on cancer patients using a mobile application intervention was previously performed (α =0.05, d=0.75). Accordingly, it was found that 23 people should be taken for each group to sampling for 80% power. Considering that there might be losses, the number of samples was increased by 10% and it was planned to include a total of 52 people in the study. Intention-to-treat analysis will be performed to manage bias and losses.
A pilot application will be conducted for 4 weeks with 6 patients regarding the usability of the mobile application and these patients will not be included in the study. At the end of 4 weeks, feedback will be received from the patients participating in the pilot application with the mobile application evaluation form. Necessary changes will be made in the mobile application in line with the feedback.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blind pre-post test randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: A mobile application intervention developed for gynecological cancer patients receiving chemotherapyExperimental group intervention consists two months a mobile application intervention developed for gynecological cancer patients receiving chemotherapy |
| No intervention | No intervention | –Control group receive routine care. |
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)
- Be over 18 years old
- Be at least primary school graduate
- Volunteering to participate in research
- Being diagnosed with gynecological cancer for the first time (no cancer recurrence)
- Receiving at least one course of chemotherapy and continuing chemotherapy treatment
Key exclusion criteria (3 listed)
- Be have any psychiatric illness
- Be have not yet received or completed chemotherapy treatment
- Be Eastern Cooperative Oncology Group (ECOG) performance scale score of 3 and above
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 |
|---|---|---|
| A mobile application intervention developed for gynecological cancer patients receiving chemotherapyThe mobile application will consist of modules. It is planned to include four education modules and consultancy modules in the application. 1. Module 1: It will consist of sub-categories with information to be prepared in line with the current literature on gynecological cancer types and treatments applied. There will be information and short videos that will strengthen coping with physical symptoms, especially from chemotherapy. 2. Module 2: In this area, there will be meditation and relaxation/breathing exercises, information on relaxing complementary therapies, anxiety reduction and stress management techniques videos and audio recordings. 3. Module 3: Current developments on gynecological cancers will be included. 4. Module 4: Encouraging recovery stories and videos of cancer survivors will be included. 5. Module 5: Counseling module. This is the area where patients who cannot find answers in the frequently asked questions section can ask questions to the research team. | Behavioural | Experimental |
Primary outcome
The Psychosocial Adjustment to İllnes Scale-Self Report (PAIS-SR)
Time frame: Change from baseline PAIS-SR score at 4 and 8 weeks
The scale measures the interaction of individuals with other individuals and institutions forming the socio-cultural environment and consists of 7 sub-dimensions. These; Health Care Orientation (8 items); Vocational Environment (6 items); Domestic Environment (8 items); Sexual Relationship (6 items); extended family relationships (5 items); social environment (6 items); psychological pressure (7 items) it consists of 46 items in total, including. It is calculated by giving scores ranging from 0 to 3 for the items in the scale. Major negative changes since illness are scored with 3 points, no change or positive changes with 0 points. A score below 35 indicates "good psychosocial adjustment", a score between 35 and 51 indicates "moderately good psychosocial adjustment", and a score above 51 indicates "poor psychosocial adjustment". An increase in the score is an indication of difficulty in adaptation and deterioration.
MD Anderson Symptom Inventory (MDASI)
Time frame: Change from baseline MDASI score at 4 and 8 weeks
It is a short inventory that measures the impact and severity of cancer-related symptoms. Each symptom is evaluated at 11 levels (0=no symptoms, 10=very bad). The scale consists of two sub-dimensions and 19 items. In the first part of the inventory, "symptoms" (13 items), in the second part "inhibition of the individual's life" (6 items) and the situation in the last 24 hours are evaluated. In the event that the life of the individual in the second part of the inventory is hindered; general activity, mood, work and/or works in home, relationships with other people, walking, enjoying life are evaluated. A high score indicates an increase in the severity of the symptom and a negative impact on life.
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from baseline HADS score at 4 and 8 weeks
The aim of the scale is not to diagnose, but to determine the risk group by scanning anxiety and depression in a short time in patients with physical illness. The scale has anxiety (HADS-A) and depression (HADS-D) subscales. The scale is a self-report scale and consists of 14 items, 7 of which investigate symptoms of anxiety and 7 of which investigate symptoms of depression. Responses are evaluated on a four-point Likert scale and scored between 0-3. Odd numbers measure anxiety, even numbers measure depression. For both subscales, "7 and below" non-patients, "8-10" borderline patients, and "11 and above" patient evaluations were deemed appropriate. The scoring of each item in the scale is different. Items 1, 3, 5, 6, 8, 10, 11, and 13 show decreasing severity and the scoring is 3, 2, 1, 0. On the other hand, the 2nd, 4th, 7th, 9th, 12th and 14th items are scored as 0, 1, 2, 3, respectively. The lowest score that can be obtained from both subscales is 0, and the highest score is 21.
Assessment of Survivor Concerns (ASC)
Time frame: Change from baseline ASC score at 4 and 8 weeks
The scale was developed in 2007 to evaluate the fear of recurrence of cancer and general health in cancer patients. The scale has two subscales: "cancer worry subscale" and "general health worry subscale". The scale included six items and three in each subscale. However, as the sixth item was 'children's health worry"' which cannot be administered to those who have no children, the scale was revised, and this item was removed. The number of items was reduced to five. The new 5-item form of the scale is recommended. According to the revised scale, the "cancer worry subscale" is comprised of three items and the "general health scale" two items. The Assessment of Survivor Concerns Scale is a 4-point Likert type scale that is evaluated as "not at all" and "very much". The lowest score possible on this scale is five and the highest is 20. Higher scores indicate higher levels of concern.
Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: Baseline
The ECOG Scale of Performance Status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). This numbering scale is one way to define the population of patients to be studied in the trial. The scale was developed by the Eastern Cooperative Oncology Group (ECOG), now part of the ECOG-ACRIN Cancer Research Group, and published in 1982. It is used to promote greater standardization among researchers who design and evaluate clinical cancer studies and to assess the general well-being of patients. A score between 0 and 5 is made.
Mobile Application Evaluation Form
Time frame: At the end of the 4-week pilot application
It is a form created by researchers to evaluate satisfaction with the use of the mobile application. With this form, after the "pilot application" from patients will receive feedback on the ease of use and content of the mobile application.
Introductory Information Form
Time frame: Baseline
It is the form that contains information about the socio-demographic characteristics of the patients diagnosed with gynecological cancer and the type, duration and stage of the diagnosed gynecological cancer, the treatments received and the number of chemotherapy cycles.
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 Feb 2023.
Related trials for Gynecologic Cancer
RecruitingPhase 2
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
Recruiting
INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study
Breast Cancer, Corpus Uteri Cancer
Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
Non Small Cell Lung Cancer, Melanoma (Skin Cancer)
Enrolling by invitation
Peer Ambassador in Gyn Onc Trials
Ovarian Cancer
RecruitingObservational study
Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study
Malignant Digestive System Neoplasm, Malignant Female Reproductive System Neoplasm
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A mobile application intervention developed for gynecological cancer patients receiving chemotherapy in people with Gynecologic Cancer and Chemotherapy Effect, run by Pamukkale University 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 3 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 Feb 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?
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?
The Psychosocial Adjustment to İllnes Scale-Self Report (PAIS-SR) (time frame: Change from baseline PAIS-SR score at 4 and 8 weeks). The study lists 7 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 Feb 2023.