CancerNCT04055948
Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Cancer Patients
A study testing One-on-one support/educational sessions and Telephone booster contact in people with Cancer, run by Case Comprehensive Cancer Center at 2 sites in United States.
Trial summary
The purpose of this study is to learn whether an education and support program can help caregivers feel more confident in technical and communication skills needed to care for a person with cancer. Patients with cancer and their caregivers face many challenges. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- One-on-one support/educational sessions and Telephone booster contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Dec 2019to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- Diagnosis of stage I, II, III cancers of the rectum and anus, stage I, II, III, IVa esophagus; stage II-III NSCLC (excluding those receiving SBRT due to short treatment course); and stage I - IV A/B head/neck (tongue, gum, oral cavity, nasopharynx, oropharynx, hypopharynx, parotid, or larynx). Stage IV A/B will be allowed for HNC and stage IVa for esophagus as the intent of therapy is curative.
- Has an identified family CG who is willing to participate.
- 18 years of age or older
- Family member or friend of an adult patient described above
- Identified by the patient as his/her primary CG, who is providing daily assistance and/or emotional support.
Who cannot join
- Patients who do not have a caregiver will be excluded.
- CGs of patients who are receiving hospice care will be excluded because of the patient's poor prognosis and multiple issues associated with end-of-life care.
- CGs who are themselves undergoing active cancer treatment will be excluded (hormonal treatment allowed).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
About this study
Official title: Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Patients With Cancer
The purpose of this study is to learn whether an education and support program can help caregivers feel more confident in technical and communication skills needed to care for a person with cancer. Patients with cancer and their caregivers face many challenges. These include learning about cancer and its treatment, coping with symptoms from illness and treatment side effects, making adjustments to usual activities, and managing the emotional effects of having a serious illness. This study is testing whether different forms of education and support can help caregivers feel better prepared. To find out if education about caregiving and different kinds of support are effective, study personnel will compare approaches to help find ways to improve the services that are provided to caregivers during cancer treatment. About 180 patients and their caregivers at the Seidman Cancer Center will take part in this study. Participating in research is voluntary and this study is funded by the National Institute of Health.
Read the detailed description
This is a 2-group, prospective, randomized controlled design to test the effect of an intervention, as compared to a usual care control group, on family caregivers (CG) outcomes, patient outcomes, and healthcare utilization outcomes during treatment.
The objectives of this study are to:
- Evaluate the effect of a CG intervention, as compared to a control group, on CG primary (anxiety) and secondary (depression, HRQOL, and fatigue) outcomes.
- Measure the effect of the intervention, as compared to a control group, on patient outcomes (HRQOL and interrupted treatment course), and healthcare utilization outcomes (unplanned hospital admissions, unplanned emergency room visits, and unplanned use of intravenous [IV] fluids).
- Determine if CG self-efficacy mediates the effect of the intervention on CG anxiety.
- Determine if patient illness factors, care demands (hours per week spent caregiving), and patient and CG demographic factors moderate the relationship between the intervention and CG outcomes.
- Compare the costs of healthcare utilization (unplanned hospital admission, unplanned emergency room visits, and unplanned use of IV fluids) between the intervention and control groups.
- Conditions
- Cancer
- Being tested
- One-on-one support/educational sessions, Telephone booster contact
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-on-one support/educational sessionsBehavioural
One-on-one support/educational sessions with the caregiver during radiation treatments (note - intervention sessions 2 \& 3 delivered by phone during COVID-19 and remained an option after the pandemic).
Telephone booster contactBehavioural
Telephone booster contact 2 weeks post-treatment.
| Study group | Role | What they receive |
|---|---|---|
| Control - Standard of Care | No intervention | CG(caregivers)/CP(cancer patients) dyads |
| Intervention | Experimental | CG/CP dyads
* Three, one-on-one support/educational sessions with the caregiver during radiation treatment, followed by a telephone booster contact 2 weeks post-treatment. Receives: Behavioral: One-on-one support/educational sessions; Behavioral: Telephone booster contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
CG Anxiety at 20 Weeks Post-treatment
Difference in CG anxiety between the intervention and control groups at 20 weeks post-radiation treatment.
CG anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 7a. This 7-item questionnaire assesses self-reported fear, worry, anxiety, tension, nervousness, and restlessness in the family caregiver over the last 7 days.
This outcome will be reporting the average T-score for anxiety as measured by the PROMIS scale. Raw scores range from 7 to 35. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater anxiety. For example, a T-score of 60 is one standard deviation worse anxiety than average.
Measured: 20 weeks post treatment
Secondary outcomes (12)
CG Anxiety at Baseline
CG anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 7a. This 7-item questionnaire assesses self-reported fear, worry, anxiety, tension, nervousness, and restlessness in the family caregiver over the last 7 days.
This outcome will be reporting the average T-score for anxiety as measured by the PROMIS scale. Raw scores range from 7 to 35. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater anxiety. For example, a T-score of 60 is one standard deviation worse anxiety than average.
Measured: Baseline
CG Anxiety at the End of Radiation Treatment
Difference in CG anxiety between the intervention and control groups at the end of radiation treatment
CG anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 7a. This 7-item questionnaire assesses self-reported fear, worry, anxiety, tension, nervousness, and restlessness in the family caregiver over the last 7 days.
This outcome will be reporting the average T-score for anxiety as measured by the PROMIS scale. Raw scores range from 7 to 35. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater anxiety. For example, a T-score of 60 is one standard deviation worse anxiety than average.
Measured: At end of treatment, average of seven weeks
CG Anxiety at 4 Weeks Post Treatment
CG anxiety between the intervention and control groups at 4 weeks post treatment.
CG anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 7a. This 7-item questionnaire assesses self-reported fear, worry, anxiety, tension, nervousness, and restlessness in the family caregiver over the last 7 days.
This outcome will be reporting the average T-score for anxiety as measured by the PROMIS scale. Raw scores range from 7 to 35. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater anxiety. For example, a T-score of 60 is one standard deviation worse anxiety than average.
Measured: 4 weeks post treatment
CG Depression
CG depression will be measured with the PROMIS Depression Short Form 8b. This 8-item questionnaire assesses caregiver self-reported negative mood (sadness, guilt), views of self (worthlessness), and social cognition (loneliness), as well as decreased positive affect and engagement. It assesses depression over the last 7 days.
This outcome will be reporting the average T-score for depression as measured by the PROMIS scale. Raw scores range from 8 to 40. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater depression. For example, a T-score of 60 is one standard deviation worse depression than average.
Measured: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
CG Health-related Quality of Life (HRQOL) as Measured by PROMIS Global Health Scale - Global Mental Health Domain
The PROMIS Global Health Scale will be scored as two separate domains - Global Physical Health and Global Mental Health. These domains are not combined for a total score. Raw scores range from 4 to 20. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents better health (Global Physical Health or Global Mental Health) than the general population. For example, a T-score of 60 is one standard deviation better health than average
Measured: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
CG HRQOL as Measured by PROMIS Global Health Scale - Global Physical Health
The PROMIS Global Health Scale will be scored as two separate domains - Global Physical Health and Global Mental Health. These domains are not combined for a total score. Raw scores range from 4 to 20. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents better health (Global Physical Health or Global Mental Health) than the general population. For example, a T-score of 60 is one standard deviation better health than average
Measured: Baseline, end of treatment, 4 weeks and 20 weeks post treatment
CG Fatigue
CG fatigue will be measured with the PROMIS Fatigue Short Form 7a, a 7-item questionnaire that evaluates the self-reported experience of fatigue (frequency, duration, intensity) and the impact of fatigue on daily activities. It assesses fatigue over the last 7 days.
This outcome will be reporting the average T-score for fatigue. Raw scores range from 7 to 35. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater fatigue. For example, a T-score of 60 is one standard deviation worse fatigue than average.
Measured: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
Participant HRQOL (Cancer Patient) as Measured by FACT-G
Participant HRQOL will be measured using the disease-specific versions of FACT-G that include common subscales (physical, social, emotional, and functional well-being) plus cancer-specific questions. The effect of the intervention on HRQOL across diagnoses will be analyzed using the common subscales. The symptom experience with each diagnostic group will be described using the cancer-specific subscale.
Participants rate their response to each item on a 5-point Likert-type scale. After reverse-scoring negatively worded questions, items are summed. Higher scores indicate better quality of life.
The FACT - Colorectal (FACT-C, Version 4) is a 37-item questionnaire that measures self-reported HRQOL in patients with colorectal cancer over the last 7 days.
Measured: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
Interrupted Treatment
Interrupted Radiation Treatment Course, defined as the total number of missed treatment days due to patient or caregiver reasons, will be determined from the patient's radiation therapy treatment record. Number of days of each episode of absence from treatment will also be recorded.
Measured: End of radiation treatment, average of seven weeks
Healthcare Utilization for Participants, as Measured by Number of Hospital Admissions
Healthcare utilization was measured by number of hospital admissions during the entire study period. These were assessed via review of the patient's medical record at T4 (end of study).
Measured: 20 weeks post treatment
Healthcare Utilization for Participants, as Measured by Number of Emergency Room Visits
Healthcare utilization was measured by number of emergency room visits during the entire study period. These were assessed via review of the patient's medical record at T4 (end of study).
Measured: 20 weeks post treatment
Healthcare Utilization for Participants, as Measured by Number of Visits for IV Hydration
Healthcare utilization was measured by number of visits for IV hydration during the entire study period. These were assessed via review of the patient's medical record at T4 (end of study).
Measured: 20 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start17 Dec 2019
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Model description
- Patient and family caregiver dyads are enrolled in this 2-group, prospective, randomized controlled design to test the effect of a caregiver intervention during radiation therapy. The study enrolled a total of 484 participants(242 dyads)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Susan Mazanec, PhD, RN, Principal investigator, Case Western Reserve University, Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055948
- Sponsor's protocol ID
- CASE4Y19
- Other IDs
- 1R37CA240707-01
- Status last verified
- Mar 2026
- First submitted
- 7 Aug 2019
- Last updated
- 30 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park S, Blackstone EC, Mazanec SR. Exploring the determinants of health literacy and its effects on health-related outcomes in family caregivers of patients with cancer. Support Care Cancer. 2025 Apr 29;33(5):433. doi: 10.1007/s00520-025-09494-7.
PubMed 40299112Mazanec SR, Blackstone E, Daly BJ. Building family caregiver skills using a simulation-based intervention for care of patients with cancer: protocol for a randomized controlled trial. BMC Nurs. 2021 Jun 9;20(1):93. doi: 10.1186/s12912-021-00612-4.
PubMed 34107914
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Patients With Cancer
- ClinicalTrials.gov ID
- NCT04055948
- Acronym / sponsor ID
- CASE4Y19
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 14 Aug 2019 (actual)
- Results
- Posted 9 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn whether an education and support program can help caregivers feel more confident in technical and communication skills needed to care for a person with cancer. Patients with cancer and their caregivers face many challenges. These include learning about cancer and its treatment, coping with symptoms from illness and treatment side effects, making adjustments to usual activities, and managing the emotional effects of having a serious illness. This study is testing whether different forms of education and support can help caregivers feel better prepared. To find out if education about caregiving and different kinds of support are effective, study personnel will compare approaches to help find ways to improve the services that are provided to caregivers during cancer treatment. About 180 patients and their caregivers at the Seidman Cancer Center will take part in this study. Participating in research is voluntary and this study is funded by the National Institute of Health.
Detailed description
This is a 2-group, prospective, randomized controlled design to test the effect of an intervention, as compared to a usual care control group, on family caregivers (CG) outcomes, patient outcomes, and healthcare utilization outcomes during treatment.
The objectives of this study are to:
- Evaluate the effect of a CG intervention, as compared to a control group, on CG primary (anxiety) and secondary (depression, HRQOL, and fatigue) outcomes.
- Measure the effect of the intervention, as compared to a control group, on patient outcomes (HRQOL and interrupted treatment course), and healthcare utilization outcomes (unplanned hospital admissions, unplanned emergency room visits, and unplanned use of intravenous [IV] fluids).
- Determine if CG self-efficacy mediates the effect of the intervention on CG anxiety.
- Determine if patient illness factors, care demands (hours per week spent caregiving), and patient and CG demographic factors moderate the relationship between the intervention and CG outcomes.
- Compare the costs of healthcare utilization (unplanned hospital admission, unplanned emergency room visits, and unplanned use of IV fluids) between the intervention and control groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patient and family caregiver dyads are enrolled in this 2-group, prospective, randomized controlled design to test the effect of a caregiver intervention during radiation therapy. The study enrolled a total of 484 participants(242 dyads)
| Arm | Type | Receives |
|---|---|---|
| Control - Standard of Care | No intervention | –CG(caregivers)/CP(cancer patients) dyads |
| Intervention | Experimental | Behavioral: One-on-one support/educational sessions, Behavioral: Telephone booster contactCG/CP dyads * Three, one-on-one support/educational sessions with the caregiver during radiation treatment, followed by a telephone booster contact 2 weeks post-treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older.
- Diagnosis of stage I, II, III cancers of the rectum and anus, stage I, II, III, IVa esophagus; stage II-III NSCLC (excluding those receiving SBRT due to short treatment course); and stage I - IV A/B head/neck (tongue, gum, oral cavity, nasopharynx, oropharynx, hypopharynx, parotid, or larynx). Stage IV A/B will be allowed for HNC and stage IVa for esophagus as the intent of therapy is curative.
- Has an identified family CG who is willing to participate.
- 18 years of age or older
- Family member or friend of an adult patient described above
Key exclusion criteria (3 listed)
- Patients who do not have a caregiver will be excluded.
- CGs of patients who are receiving hospice care will be excluded because of the patient's poor prognosis and multiple issues associated with end-of-life care.
- CGs who are themselves undergoing active cancer treatment will be excluded (hormonal treatment allowed).
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 |
|---|---|---|
| One-on-one support/educational sessionsOne-on-one support/educational sessions with the caregiver during radiation treatments (note - intervention sessions 2 \& 3 delivered by phone during COVID-19 and remained an option after the pandemic). | Behavioural | Intervention |
| Telephone booster contactTelephone booster contact 2 weeks post-treatment. | Behavioural | Intervention |
Primary outcome
CG Anxiety at 20 Weeks Post-treatment
Time frame: 20 weeks post treatment
Difference in CG anxiety between the intervention and control groups at 20 weeks post-radiation treatment. CG anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 7a. This 7-item questionnaire assesses self-reported fear, worry, anxiety, tension, nervousness, and restlessness in the family caregiver over the last 7 days. This outcome will be reporting the average T-score for anxiety as measured by the PROMIS scale. Raw scores range from 7 to 35. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater anxiety. For example, a T-score of 60 is one standard deviation worse anxiety than average.
12 secondary outcomes
CG Anxiety at Baseline
Time frame: Baseline
CG Anxiety at the End of Radiation Treatment
Time frame: At end of treatment, average of seven weeks
CG Anxiety at 4 Weeks Post Treatment
Time frame: 4 weeks post treatment
CG Depression
Time frame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
CG Health-related Quality of Life (HRQOL) as Measured by PROMIS Global Health Scale - Global Mental Health Domain
Time frame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
CG HRQOL as Measured by PROMIS Global Health Scale - Global Physical Health
Time frame: Baseline, end of treatment, 4 weeks and 20 weeks post treatment
CG Fatigue
Time frame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
Participant HRQOL (Cancer Patient) as Measured by FACT-G
Time frame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
Interrupted Treatment
Time frame: End of radiation treatment, average of seven weeks
Healthcare Utilization for Participants, as Measured by Number of Hospital Admissions
Time frame: 20 weeks post treatment
Healthcare Utilization for Participants, as Measured by Number of Emergency Room Visits
Time frame: 20 weeks post treatment
Healthcare Utilization for Participants, as Measured by Number of Visits for IV Hydration
Time frame: 20 weeks post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40299112Park S, Blackstone EC, Mazanec SR. Exploring the determinants of health literacy and its effects on health-related outcomes in family caregivers of patients with cancer. Support Care Cancer. 2025 Apr 29;33(5):433. doi: 10.1007/s00520-025-09494-7.
- Derived from this study: PubMed 34107914Mazanec SR, Blackstone E, Daly BJ. Building family caregiver skills using a simulation-based intervention for care of patients with cancer: protocol for a randomized controlled trial. BMC Nurs. 2021 Jun 9;20(1):93. doi: 10.1186/s12912-021-00612-4.
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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.
Susan Mazanec, PhD, RN principal investigator
Case Western Reserve University, Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-on-one support/educational sessions and Telephone booster contact in people with Cancer, run by Case Comprehensive Cancer Center at 2 sites in United States.
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 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 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 9 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
CG Anxiety at 20 Weeks Post-treatment (time frame: 20 weeks post treatment). 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 NCT04055948, which also lists 2 linked publications.
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 30 Mar 2026.