Breast Ductal Carcinoma In SituNCT07909525
Addressing Financial Hardship in AYA Cancer Survivors Through the Use of the New LIFT UP Intervention
A study testing Best Practice, Educational Intervention and Informational Intervention in people with Breast Ductal Carcinoma In Situ and Hematopoietic and Lymphatic System Neoplasm, run by ECOG-ACRIN Cancer Research Group.
Trial summary
This clinical trial addresses the financial hardship among adolescent and young adult (AYA) survivors using the new Lessening the Impact of Financial Toxicity (LIFT) UP intervention. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Breast Ductal Carcinoma In Situ, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Best Practice, Educational Intervention and Informational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- No sites listed yet
- Study dates
- 24 Nov 2026to 30 Oct 2029
- 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 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- NON-PATIENT PARTICIPANTS ELIGIBILITY CRITERIA FOR STEP 0 (SCREENING)
- Participant must immediately be enrolled to Step 1 (Registration)
- NON-PATIENT PARTICIPANTS ELIGIBILITY CRITERIA FOR STEP 1 (REGISTRATION)
- Participant must speak English
- Participant must be employed at a NCORP site for at least six months
- Participant must be able to provide informed consent to participate in this study
Show all 28Show fewer
- Participant must be one or more of the following:
- Staff who identify AYA patients at risk of financial hardship and/or provide targeted resources to meet needs (e.g., patient navigators, financial counselors, social workers, oncology nurses, APPs).
- Staff who have provided care or been in contact (in the last 3 months) with an AYA patient who was assigned the LIFT UP intervention arm (e.g., centralized navigator).
- Staff with an administrative role related to care for AYA patients at risk of financial hardship (e.g., cancer program administrators, hospital/clinic billing specialists).
- ELIGIBILITY CRITERIA FOR STEP 0 (REGISTRATION) (AYA PARTICIPANT ELIGIBILITY CRITERIA)
- Participant must be 18 to 39 years of age at the time of Oncology Patient Enrollment Network (OPEN) registration
- Participant must have been diagnosed between 15-39 years of age with histologically proven malignancy (stage 0-3 or stage IV with M0 or MX disease, any type including ductal carcinoma in situ (DCIS) but excluding non-melanoma skin cancer)
- Participant must have completed curative intent therapy
- NOTE: Ongoing hormone therapy or oral oncolytic treatment is permissible
- Participant's date of last curative intent therapy must be less than or equal to 5 years ago. AYA participants must have completed their radiation or surgery if applicable
- Participant must not have been enrolled in EAQ221CD, EAQ222CD, S1912CD, or past trials of CHAT or LIFT since financial navigation and/or health insurance literacy is offered as part of those trials
- Participant must not have any history of previously diagnosed or concurrent malignancies (excluding non-melanoma skin cancer)
- Participant must not currently be receiving hospice or end of life care. Participants on palliative care are eligible
- Participant must be able to read and speak English in order to be able to provide informed consent and complete assessments
- Participant must have a personal email address and private access to the internet (via smartphone, tablet, or computer)
- NOTE: A personal email address is required in order to create a secure Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Systems for Easy Entry of Participant Reported Outcomes (EASEE-PRO) account, receive timely survey notifications, and complete surveys on-line
- NOTE: The restriction to those with internet access is based on the primary intention of the study which involves intervention content delivered via the internet
- NOTE: "Private access" is required because of the personal nature of some of the study conversations and refers to the ability to engage with this content in a manner that will allow the participant to preserve the confidentiality of their participation in the study. For example, a computer in the main room of the library that is viewable to all may not adequately protect the participant, while a cubicle or computer room may
- ELIGIBILITY CRITERIA FOR STEP 1 (RANDOMIZATION) (AYA PARTICIPANT ELIGIBILITY CRITERIA)
- Participant must meet all the eligibility criteria for Step 0
- Participant must have a completed baseline survey within 30 days after the date of OPEN screening Registration (Step 0)
- Step 1 registration must be within 14 days after completing the baseline survey
Who cannot join
None listed.
About this study
Official title: Addressing Financial Hardship in AYA Cancer Survivors: Efficacy and Implementation of a Multilevel Intervention (LIFT UP) in Community-Based Oncology Practices
This clinical trial addresses the financial hardship among adolescent and young adult (AYA) survivors using the new Lessening the Impact of Financial Toxicity (LIFT) UP intervention. AYAs with cancer experience significant and prolonged disruption in their lives due to their diagnosis and are at greater risk of financial hardship than any other age group with cancer. For AYA patients, health insurance literacy - one's ability to make informed decisions about choosing and using health insurance - is likely an essential component of being able to navigate care and manage costs. A promising strategy for addressing AYA financial hardship is to streamline existing, successful interventions into a single multilevel intervention. More specifically, combining patient education from a health insurance literacy intervention called CHAT (Let's CHAT about health insurance), which helps to address the book knowledge with organization support and financial navigation from an intervention called LIFT, which addresses the experiential knowledge could yield positive outcomes for AYAs. The addition of LIFT UP to usual care may improve AYA access to financial resources and reduce medical costs and distress associated with financial hardship.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare the change of self-reported financial hardship from baseline to 6-month follow-up between arms.
II. To compare the change of self-reported health insurance literacy from baseline to 6-month follow-up between arms.
SECONDARY OBJECTIVES:
- To compare the change of self-reported material financial hardship from baseline to 6-month follow-up between arms.
II. To compare the change of self-reported psychological financial hardship from baseline to 6-month follow-up between arms.
III. To compare the change of self-reported behavioral aspects of financial hardship from baseline to 6-month follow-up between arms.
IV. To assess longitudinal changes of self-reported outcomes (financial hardship, health insurance literacy, material financial hardship, psychological financial hardship, behavioral aspects of financial hardship) from baseline to 12-month follow-up between arms.
- To identify barriers and facilitators of LIFT UP implementation through qualitative interviews with AYA participants and non-patient participants (National Cancer Institute Community Oncology Research Program [NCORP] staff).
EXPLORATORY OBJECTIVES:
- To determine proportion of application and approval for financial assistance at 3-, 6-, and 12- month follow-up by arm.
II. To evaluate health service utilization of emergency departments, scheduled and unscheduled hospital admissions, scheduled office visits, and urgent care visits over the duration of the study by arm.
III. To determine proportion of self-reported return to work or school at each of the follow-up assessments by arm.
IV. To assess whether behavioral self-management and health insurance literacy mediate the impact of social determinants of health, as well as clinical and institutional variables, on self-reported financial hardship and health service utilization. V. To assess whether supportive services moderate the relationship between social determinants of health, clinical and institutional variables, and self-reported financial hardship and health service utilization.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (LIFT UP): Patients receive an intervention booklet and attend virtual interactive sessions comprising CHAT and LIFT via videoconference over 60 minutes biweekly for up to 4 sessions. Patients may attend additional sessions if needed. Patients are followed up at 3, 6, and 12 months. Patients may optionally attend a virtual interview over 60 minutes after completion of 12 month survey.
ARM II (USUAL CARE): Patients receive usual care. Patients are followed up at 3, 6, and 12 months.
- Conditions
- Breast Ductal Carcinoma In Situ, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- Being tested
- Best Practice, Educational Intervention, Informational Intervention, Interview, Survey Administration
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive CHAT and LIFT intervention via videoconference
Informational InterventionOther
Receive intervention booklet
InterviewOther
Attend a virtual interview
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| ARM I (LIFT UP) | Experimental | Patients receive an intervention booklet and attend virtual interactive sessions comprising CHAT and LIFT via videoconference over 60 minutes biweekly for up to 4 sessions. Patients may attend additional sessions if needed. Patients are followed up at 3, 6, and 12 months. Patients may optionally attend a virtual interview over 60 minutes after completion of 12 month survey. Receives: Other: Educational Intervention; Other: Informational Intervention; Other: Interview; Other: Survey Administration |
| ARM II (USUAL CARE) | Active comparator | Patients receive usual care. Patients are followed up at 3, 6, and 12 months. Receives: Other: Best Practice; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of financial hardship
Will be measured by Comprehensive Score for Financial Toxicity (FACIT-COST). Will calculate the difference in COST from baseline to 6-month follow-ups for adolescents and young adults (AYA) participants who provide data at each time point and use two-sample t-tests (two sided) to assess if mean differences are significantly different between arms. If the data are not normally distributed, nonparametric methods (e.g., Wilcoxon rank-sum test) will be used to assess the difference. To control for confounders, will fit linear regressions with the change of COST from baseline to 6-month follow-up as the response variable and age, race/ethnicity, socioeconomic status, disease type, sex, and other social determinants of health as covariates. Will stratify analysis by age stratum (18-25 years-old versus [vs] 26-39 years-old), sex, and race to minimize bias.
Measured: Baseline up to 6 months after randomization
Change in health insurance literacy
Will be measured by the Health Insurance Literacy Measure (HILM). The HILM co-primary endpoint will be analyzed restricted to AYA participants insured at baseline (modified intention to treat [ITT] for HILM), AYA participants with valid HILM-9 scores at baseline and 6 months. An ITT analysis using multiple imputation will be performed to handle missing HILM scores (including those for uninsured participants), with insurance status and other prespecified covariates included in the imputation model.
Measured: Baseline up to 6 months after randomization
Secondary outcomes (7)
Change of self-reported material financial hardship
Will be assessed using Childhood Cancer Survivor Study Long-Term Follow-Up Survey that assess material subdomains of financial hardship.
Measured: Baseline up to 6 months after randomization
Change of self-reported psychological financial hardship
Psychological financial hardship will be assessed using the applicable CCSS Long-Term Follow-Up Health Insurance Survey items. Item responses will be aggregated into a single domain-level ordinal measure based on the number of psychological hardship instances reported: 0, 1-2, or ≥3 instances. Change from baseline to 6 months will be compared between randomized arms.
Measured: Baseline up to 6 months after randomization
Change of self-reported behavioral aspects of financial hardship
Behavioral financial hardship will be assessed using the 10 behavioral hardship items from the CCSS Long-Term Follow-Up Health Insurance Survey. Item responses will be aggregated into a single domain-level ordinal measure based on the number of behavioral hardship instances reported: 0, 1-2, or ≥3 instances. Change from baseline to 6 months will be compared between randomized arms.
Measured: Baseline up to 6 months after randomization
Change of self-reported material financial hardship
Material financial hardship will be assessed using the 9 material hardship items from the CCSS Long-Term Follow-Up Health Insurance Survey. Item responses will be aggregated into a single domain-level ordinal measure based on the number of material hardship instances reported: 0, 1-2, or ≥3 instances. Longitudinal change in this measure from baseline through 12 months will be compared between randomized arms.
Measured: Baseline up to 12 months after randomization
Change of self-reported psychological financial hardship
Psychological financial hardship will be assessed using the applicable CCSS Long-Term Follow-Up Health Insurance Survey items. Item responses will be aggregated into a single domain-level ordinal measure based on the number of psychological hardship instances reported: 0, 1-2, or ≥3 instances. Longitudinal change in this measure from baseline through 12 months will be compared between randomized arms.
Measured: Baseline up to 12 months after randomization
Change of self-reported behavioral aspects of financial hardship
Behavioral financial hardship will be assessed using the 10 behavioral hardship items from the CCSS Long-Term Follow-Up Health Insurance Survey. Item responses will be aggregated into a single domain-level ordinal measure based on the number of behavioral hardship instances reported: 0, 1-2, or ≥3 instances. Longitudinal change in this measure from baseline through 12 months will be compared between randomized arms.
Measured: Baseline up to 12 months after randomization
Barriers and facilitators of LIFT UP implementation
Assessed via qualitative interviews with AYA participants and non-patient participants. Analysis will be guided by a codebook informed by the Consolidated Framework for Implementation Research and the Theoretical Domains Framework and conducted in Atlas.ti, a multifunctional qualitative data analysis software
Measured: Up to 13 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start24 Nov 2026 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Ductal Carcinoma In SituStudies of the same condition, open and under way.
- More trials run by ECOG-ACRIN Cancer Research GroupThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 448 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- John M Salsman, Principal investigator, ECOG-ACRIN Cancer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909525
- Sponsor's protocol ID
- EAQ241CD
- Other IDs
- NCI-2026-04111, EAQ241CD, ECOG-ACRIN-EAQ241CD, EAQ241CD, R01CA282653, UG1CA189828
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2026
- Last updated
- 2 Nov 2026
- 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Financial Hardship in AYA Cancer Survivors: Efficacy and Implementation of a Multilevel Intervention (LIFT UP) in Community-Based Oncology Practices
- ClinicalTrials.gov ID
- NCT07909525
- Acronym / sponsor ID
- EAQ241CD
- Conditions
- Breast Ductal Carcinoma In Situ, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 448 participants (estimated)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Nov 2026 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 2 Nov 2026 (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.
This clinical trial addresses the financial hardship among adolescent and young adult (AYA) survivors using the new Lessening the Impact of Financial Toxicity (LIFT) UP intervention. AYAs with cancer experience significant and prolonged disruption in their lives due to their diagnosis and are at greater risk of financial hardship than any other age group with cancer. For AYA patients, health insurance literacy - one's ability to make informed decisions about choosing and using health insurance - is likely an essential component of being able to navigate care and manage costs. A promising strategy for addressing AYA financial hardship is to streamline existing, successful interventions into a single multilevel intervention. More specifically, combining patient education from a health insurance literacy intervention called CHAT (Let's CHAT about health insurance), which helps to address the book knowledge with organization support and financial navigation from an intervention called LIFT, which addresses the experiential knowledge could yield positive outcomes for AYAs. The addition of LIFT UP to usual care may improve AYA access to financial resources and reduce medical costs and distress associated with financial hardship.
Detailed description
PRIMARY OBJECTIVES:
- To compare the change of self-reported financial hardship from baseline to 6-month follow-up between arms.
II. To compare the change of self-reported health insurance literacy from baseline to 6-month follow-up between arms.
SECONDARY OBJECTIVES:
- To compare the change of self-reported material financial hardship from baseline to 6-month follow-up between arms.
II. To compare the change of self-reported psychological financial hardship from baseline to 6-month follow-up between arms.
III. To compare the change of self-reported behavioral aspects of financial hardship from baseline to 6-month follow-up between arms.
IV. To assess longitudinal changes of self-reported outcomes (financial hardship, health insurance literacy, material financial hardship, psychological financial hardship, behavioral aspects of financial hardship) from baseline to 12-month follow-up between arms.
- To identify barriers and facilitators of LIFT UP implementation through qualitative interviews with AYA participants and non-patient participants (National Cancer Institute Community Oncology Research Program [NCORP] staff).
EXPLORATORY OBJECTIVES:
- To determine proportion of application and approval for financial assistance at 3-, 6-, and 12- month follow-up by arm.
II. To evaluate health service utilization of emergency departments, scheduled and unscheduled hospital admissions, scheduled office visits, and urgent care visits over the duration of the study by arm.
III. To determine proportion of self-reported return to work or school at each of the follow-up assessments by arm.
IV. To assess whether behavioral self-management and health insurance literacy mediate the impact of social determinants of health, as well as clinical and institutional variables, on self-reported financial hardship and health service utilization. V. To assess whether supportive services moderate the relationship between social determinants of health, clinical and institutional variables, and self-reported financial hardship and health service utilization.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (LIFT UP): Patients receive an intervention booklet and attend virtual interactive sessions comprising CHAT and LIFT via videoconference over 60 minutes biweekly for up to 4 sessions. Patients may attend additional sessions if needed. Patients are followed up at 3, 6, and 12 months. Patients may optionally attend a virtual interview over 60 minutes after completion of 12 month survey.
ARM II (USUAL CARE): Patients receive usual care. Patients are followed up at 3, 6, and 12 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM I (LIFT UP) | Experimental | Other: Educational Intervention, Other: Informational Intervention, Other: Interview, Other: Survey AdministrationPatients receive an intervention booklet and attend virtual interactive sessions comprising CHAT and LIFT via videoconference over 60 minutes biweekly for up to 4 sessions. Patients may attend additional sessions if needed. Patients are followed up at 3, 6, and 12 months. Patients may optionally attend a virtual interview over 60 minutes after completion of 12 month survey. |
| ARM II (USUAL CARE) | Active comparator | Other: Best Practice, Other: Survey AdministrationPatients receive usual care. Patients are followed up at 3, 6, and 12 months. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (28 listed)
- NON-PATIENT PARTICIPANTS ELIGIBILITY CRITERIA FOR STEP 0 (SCREENING)
- Participant must immediately be enrolled to Step 1 (Registration)
- NON-PATIENT PARTICIPANTS ELIGIBILITY CRITERIA FOR STEP 1 (REGISTRATION)
- Participant must speak English
- Participant must be employed at a NCORP site for at least six months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | ARM II (USUAL CARE) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive CHAT and LIFT intervention via videoconference | Other | ARM I (LIFT UP) |
| Informational InterventionReceive intervention booklet | Other | ARM I (LIFT UP) |
| InterviewAttend a virtual interview | Other | ARM I (LIFT UP) |
| Survey AdministrationAncillary studies | Other | ARM I (LIFT UP), ARM II (USUAL CARE) |
Primary outcome
Change of financial hardship
Time frame: Baseline up to 6 months after randomization
Will be measured by Comprehensive Score for Financial Toxicity (FACIT-COST). Will calculate the difference in COST from baseline to 6-month follow-ups for adolescents and young adults (AYA) participants who provide data at each time point and use two-sample t-tests (two sided) to assess if mean differences are significantly different between arms. If the data are not normally distributed, nonparametric methods (e.g., Wilcoxon rank-sum test) will be used to assess the difference. To control for confounders, will fit linear regressions with the change of COST from baseline to 6-month follow-up as the response variable and age, race/ethnicity, socioeconomic status, disease type, sex, and other social determinants of health as covariates. Will stratify analysis by age stratum (18-25 years-old versus [vs] 26-39 years-old), sex, and race to minimize bias.
Change in health insurance literacy
Time frame: Baseline up to 6 months after randomization
Will be measured by the Health Insurance Literacy Measure (HILM). The HILM co-primary endpoint will be analyzed restricted to AYA participants insured at baseline (modified intention to treat [ITT] for HILM), AYA participants with valid HILM-9 scores at baseline and 6 months. An ITT analysis using multiple imputation will be performed to handle missing HILM scores (including those for uninsured participants), with insurance status and other prespecified covariates included in the imputation model.
7 secondary outcomes
Change of self-reported material financial hardship
Time frame: Baseline up to 6 months after randomization
Change of self-reported psychological financial hardship
Time frame: Baseline up to 6 months after randomization
Change of self-reported behavioral aspects of financial hardship
Time frame: Baseline up to 6 months after randomization
Change of self-reported material financial hardship
Time frame: Baseline up to 12 months after randomization
Change of self-reported psychological financial hardship
Time frame: Baseline up to 12 months after randomization
Change of self-reported behavioral aspects of financial hardship
Time frame: Baseline up to 12 months after randomization
Barriers and facilitators of LIFT UP implementation
Time frame: Up to 13 months after randomization
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 2 Nov 2026.
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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.
John M Salsman principal investigator
ECOG-ACRIN Cancer Research Group
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Educational Intervention and Informational Intervention in people with Breast Ductal Carcinoma In Situ and Hematopoietic and Lymphatic System Neoplasm, run by ECOG-ACRIN Cancer Research Group.
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 28 inclusion and 0 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Change of financial hardship (time frame: Baseline up to 6 months after randomization). The study lists 2 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 2 Nov 2026.