CancerAYA STEPSNCT06371768
Symptom Management and Transitioning to Engagement With Post-treatment Care for Adolescent and Young Adult Cancer Survivors
A study testing AYA Educational Information and AYA STEPS in people with Cancer and Breast Cancer, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of a digital health program called AYA STEPS, which is designed to help adolescent and young adult (AYA) cancer survivors manage symptoms and engage in recommended follow-up care. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Cancer, Breast Cancer, Colorectal Cancer
- What is being tested?
- AYA Educational Information and AYA STEPS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2025to 30 Jun 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
- Diagnosed with one of the following cancers: 1) stage I-III breast cancer; 2) stage I-III colorectal cancer; 3) stage I-III sarcoma; 4) stage I-III Hodgkin or non-Hodgkin lymphoma; or 5) stage I-II testicular cancer
- treated with curative intent and off therapy (with the exception of endocrine/hormonal therapy or oral targeted therapies used to prevent disease recurrence or progression) for the last three months
- 1 to 5 years post-diagnosis
- Able to speak and read English
- Able to give informed consent
Who cannot join
- moderate or severe cognitive impairment
- severe untreated mental illness (e.g., schizophrenia, substance use disorder) that would interfere with providing meaningful consent/study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27705
Michael W Willis, 919-681-8437, michael.w.willis@duke.edu
Smrithi Divakaran, MPH, 919-681-7695, smrithi.divakaran@duke.edu
About this study
The purpose of this study is to determine the effectiveness of a digital health program called AYA STEPS, which is designed to help adolescent and young adult (AYA) cancer survivors manage symptoms and engage in recommended follow-up care.
Read the detailed description
The investigators have developed an accessible digital health intervention, AYA STEPS (Symptom Management and Transitioning to Engagement with Post-Treatment Care for AYA Survivors), designed to enhance adolescent and young adult (AYA) cancer survivors' abilities to manage their high symptom burden and engage in follow-up health care. Informed by the Obesity-Related Behavioral Intervention Trials (ORBIT) Model of intervention development, AYA STEPS has been systematically and rigorously developed and refined through the PI's prior work (K08CA245107). AYA STEPS is organized into six remotely delivered sessions providing cognitive-behavioral and patient activation theory-based skills expected to lead to lower symptom burden and increased health care engagement by improving AYAs' self-efficacy for symptom management and activation. The investigators propose a randomized controlled trial to examine the efficacy of AYA STEPS compared to AYA educational information for improving symptom burden and health care engagement for AYA survivors (N=260) who received cancer care in diverse health care settings (i.e., rural, urban, medically underserved areas) across North Carolina. Self-efficacy and patient activation will be examined as mediators of intervention effects. The planned study has the potential to produce clinically impactful health benefits for an underserved and understudied group of cancer survivors who have significant symptom burden, experience barriers to care engagement, and have limited access to AYA-specific behavioral interventions.
- Conditions
- Cancer, Breast Cancer, Colorectal Cancer, Sarcoma, Lymphoma, Testicular Cancer
- Being tested
- AYA Educational Information, AYA STEPS
- Keywords
- Cancer, Young Adult, Behavioral Symptom Management
- Medical subject headings
- Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Sarcoma, Lymphoma, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AYA Educational InformationBehavioural
AYA-specific educational information is delivered using video conferencing by a clinical psychologist over six sessions. Participants will receive a written manual providing tips for engaging with educational content as well as access to a website specific to the control arm, which will provide written, video, and pictorial information.
AYA STEPSBehavioural
The intervention provides cognitive-behavioral and patient activation theory-based skills designed to enhance AYA survivors' abilities to manage their high symptom burden and engage in follow-up health care. Sessions with the psychologist will focus on enhancing participants' abilities to apply intervention skills and engage in the AYA STEPS digital health intervention using motivational interviewing, goal setting, and problem-solving techniques. Participants will complete the six sessions over the 12 weeks of the AYA STEPS intervention.
| Study group | Role | What they receive |
|---|---|---|
| Education Control | Active comparator | The education control condition will match AYA STEPS in delivery format [videoconferencing, web-based platform, frequency (biweekly sessions)], and session number (six) and length. Receives: Behavioral: AYA Educational Information |
| AYA STEPS | Experimental | Participants will receive the AYA STEPS digital health intervention, which includes six sessions delivered remotely (i.e., videoconferencing) by a clinical psychologist with intervention content accessed using a web-based platform. Receives: Behavioral: AYA STEPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity and interference as measured by Brief Pain Inventory
The Brief Pain Inventory will be used to assess pain severity and interference from pain across important life domains (e.g., general activity, work, relations with others). This measures includes a body map on which the patient can mark the location(s) in which they are experiencing pain, as well as 8 questions on a scale of 0 to 10 with higher scores indicating worse pain severity or pain interference.
Measured: Baseline, 3 Months, 6 Months, 12 Months
Fatigue as measured by PROMIS Fatigue Scale
Fatigue will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale, a 6-item self-report measure of fatigue. Participants are asked to think about the last week when responding to each item (e.g., "In the past 7 days, how run-down did you feel, on average?"), providing ratings on a scale from "not at all" (1) to "very much" (5).
Measured: Baseline, 3 Months, 6 Months, 12 Months
Emotional distress as measured by PROMIS Depression Short Form
Depressive symptoms will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form, an 8-item measure assessing symptoms of depression in the last week. Responses are on a 5-point scale from "never" (1) to "always" (5).
Measured: Baseline, 3 Months, 6 Months, 12 Months
Emotional distress as measured by PROMIS Anxiety Short Form
Symptoms of Anxiety will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form, an 8-item measure assessing symptoms of anxiety in the last week. Responses are on a 5-point scale from "never" (1) to "always" (5).
Measured: Baseline, 3 Months, 6 Months, 12 Months
Symptom interference as measured by MD Anderson Symptom Inventory (MDASI) Symptom Interference
The MDASI will be used to assess interference of symptoms in daily living (e.g., working, relations with other people, enjoyment of life) over the past month. The MDASI asks patients to rate the severity of 13 symptoms found frequently in patients with various cancers and treatment types on a scale from 0 (symptom "not present") to 10 (symptom "as bad as you can imagine"). This measure also includes 6 questions asking patients to rate the level of symptom interference in six domains (e.g., general activity, mood) on a scale from 0 (did not interfere) to 10 (interfered completely).
Measured: Baseline, 3 Months, 6 Months, 12 Months
Health care engagement as measured by Patient Participation Questionnaire
The Patient Participation Questionnaire will be used to assess participants' health care participation and associated domains (i.e., receipt of information, communication, perceptions of their relationship with the medical team). Participants are asked to indicate their agreement with 17 items related to health care engagement on a 4 point scale: "to a great extent," "to some extent," "to a lesser extent," or "not at all." An additional item asks patients about their overall assessment of their involvement in their healthcare.
Measured: Baseline, 3 Months, 6 Months, 12 Months
Patient self-assessment of communication competency with health care providers as measured by Medical Communication Competence Scale (MCCS) patient subscale
The MCCS patient subscale will be used to assess survivors' perceptions of their competency for communicating and participating in health care. The patient subscale includes 39 items on a scale of 1 to 7, with higher scores reflecting self-perception of better medical communication competence.
Measured: Baseline, 3 Months, 6 Months, 12 Months
Secondary outcomes (4)
Patient self-efficacy for chronic disease coping as measured by Self-Efficacy for Managing Chronic Illness Scale
The 6-item Self-Efficacy for Managing Chronic Illness Scale will be used to assess participants' current confidence in their ability to prevent symptoms (e.g., pain, fatigue, distress) from interfering with life. Responses are on a 10-point scale from "not at all confident" (1) to "totally confident" (10).
Measured: Baseline, 3 Months, 6 Months, 12 Months
Patient activation as measured by Patient Activation Measure (PAM)
The PAM is a 13-item measure used to assess survivors' knowledge, skills, and confidence that are central to managing their health and health care. Patients are asked to rate their agreement with statements about their health and health care on a 4 point scale from "strongly disagree" to "strongly agree." From these response a total PAM score is calculated on a scale of 0-100, with higher scores indicating higher levels of activation.
Measured: Baseline, 3 Months, 6 Months, 12 Months
Patient self-efficacy for managing chronic conditions as measured by the PROMIS Self-Efficacy for Managing Symptoms Short Form
The 4-item PROMIS Self-Efficacy for Managing Symptoms will be used to assess participants' confidence in their ability to manage symptoms (e.g. during daily activities, in a public place). Items are scored on a 5-point Likert scale, with higher scores indicating greater confidence.
Measured: Baseline, 3 Months, 6 Months, 12 Months
General patient self-efficacy as measured by the PROMIS General Self-Efficacy Short Form
The 4-item PROMIS General Self-Efficacy will be used to assess participants' general confidence in their abilities (e.g., to solve problems and persist toward goals). Items are scored on a 5-point Likert scale, with higher scores indicating greater confidence.
Measured: Baseline, 3 Months, 6 Months, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start14 Jul 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (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 CancerStudies of the same condition, open and under way.
- More trials run by Duke 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371768
- Sponsor's protocol ID
- Pro00115400
- Other IDs
- 5R37CA283353-02
- Acronym
- AYA STEPS
- Status last verified
- Jan 2026
- First submitted
- 11 Apr 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is the investigators' intention to make all data generated from this proposal freely available after it is de-identified. All direct respondent identifiers (e.g., names and addresses) will be removed and maintained in a secure file for future contact purposes. Respondent identifiers will not be shared. All other scientific data (scale composites) will be both preserved and shared. The following data will be preserved and shared: patient-reported data from study assessments, intervention utilization data collected via the study websites, healthcare utilization data collected from the health record, socio-demographic and medical data collected via patient report and health record, and scores on social determinant of health assessments (e.g., Area Deprivation Index). The investigators will make every effort to provide raw data in a non-proprietary format wherever possible to enhance reproducibility.
Publications
Dorfman CS, Arthur SS, Shelby RA, Stalls JM, Arrato NA, Somers TJ, Wu Y, Thomas SM, Willis MW, Youssef D, Divakaran S, Corbett C, Grilley-Olson J, Oeffinger KC. Symptom management and transitioning to engagement with post-treatment care for adolescent and young adult cancer survivors (AYA STEPS): Study protocol. Contemp Clin Trials. 2026 Jul 8;168:108391. doi: 10.1016/j.cct.2026.108391. Online ahead of print.
PubMed 42419501
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Management and Transitioning to Engagement With Post-treatment Care for Adolescent and Young Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT06371768
- Acronym / sponsor ID
- AYA STEPS / Pro00115400
- Conditions
- Cancer, Breast Cancer, Colorectal Cancer, Sarcoma, Lymphoma, Testicular Cancer
- Keywords
- Cancer, Young Adult, Behavioral Symptom Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 17 Apr 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.
The purpose of this study is to determine the effectiveness of a digital health program called AYA STEPS, which is designed to help adolescent and young adult (AYA) cancer survivors manage symptoms and engage in recommended follow-up care.
Detailed description
The investigators have developed an accessible digital health intervention, AYA STEPS (Symptom Management and Transitioning to Engagement with Post-Treatment Care for AYA Survivors), designed to enhance adolescent and young adult (AYA) cancer survivors' abilities to manage their high symptom burden and engage in follow-up health care. Informed by the Obesity-Related Behavioral Intervention Trials (ORBIT) Model of intervention development, AYA STEPS has been systematically and rigorously developed and refined through the PI's prior work (K08CA245107). AYA STEPS is organized into six remotely delivered sessions providing cognitive-behavioral and patient activation theory-based skills expected to lead to lower symptom burden and increased health care engagement by improving AYAs' self-efficacy for symptom management and activation. The investigators propose a randomized controlled trial to examine the efficacy of AYA STEPS compared to AYA educational information for improving symptom burden and health care engagement for AYA survivors (N=260) who received cancer care in diverse health care settings (i.e., rural, urban, medically underserved areas) across North Carolina. Self-efficacy and patient activation will be examined as mediators of intervention effects. The planned study has the potential to produce clinically impactful health benefits for an underserved and understudied group of cancer survivors who have significant symptom burden, experience barriers to care engagement, and have limited access to AYA-specific behavioral interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education Control | Active comparator | Behavioral: AYA Educational InformationThe education control condition will match AYA STEPS in delivery format [videoconferencing, web-based platform, frequency (biweekly sessions)], and session number (six) and length. |
| AYA STEPS | Experimental | Behavioral: AYA STEPSParticipants will receive the AYA STEPS digital health intervention, which includes six sessions delivered remotely (i.e., videoconferencing) by a clinical psychologist with intervention content accessed using a web-based platform. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosed with one of the following cancers: 1) stage I-III breast cancer; 2) stage I-III colorectal cancer; 3) stage I-III sarcoma; 4) stage I-III Hodgkin or non-Hodgkin lymphoma; or 5) stage I-II testicular cancer
- treated with curative intent and off therapy (with the exception of endocrine/hormonal therapy or oral targeted therapies used to prevent disease recurrence or progression) for the last three months
- 1 to 5 years post-diagnosis
- Able to speak and read English
- Able to give informed consent
Key exclusion criteria (2 listed)
- moderate or severe cognitive impairment
- severe untreated mental illness (e.g., schizophrenia, substance use disorder) that would interfere with providing meaningful consent/study participation
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 |
|---|---|---|
| AYA Educational InformationAYA-specific educational information is delivered using video conferencing by a clinical psychologist over six sessions. Participants will receive a written manual providing tips for engaging with educational content as well as access to a website specific to the control arm, which will provide written, video, and pictorial information. | Behavioural | Education Control |
| AYA STEPSThe intervention provides cognitive-behavioral and patient activation theory-based skills designed to enhance AYA survivors' abilities to manage their high symptom burden and engage in follow-up health care. Sessions with the psychologist will focus on enhancing participants' abilities to apply intervention skills and engage in the AYA STEPS digital health intervention using motivational interviewing, goal setting, and problem-solving techniques. Participants will complete the six sessions over the 12 weeks of the AYA STEPS intervention. | Behavioural | AYA STEPS |
Primary outcome
Pain severity and interference as measured by Brief Pain Inventory
Time frame: Baseline, 3 Months, 6 Months, 12 Months
The Brief Pain Inventory will be used to assess pain severity and interference from pain across important life domains (e.g., general activity, work, relations with others). This measures includes a body map on which the patient can mark the location(s) in which they are experiencing pain, as well as 8 questions on a scale of 0 to 10 with higher scores indicating worse pain severity or pain interference.
Fatigue as measured by PROMIS Fatigue Scale
Time frame: Baseline, 3 Months, 6 Months, 12 Months
Fatigue will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale, a 6-item self-report measure of fatigue. Participants are asked to think about the last week when responding to each item (e.g., "In the past 7 days, how run-down did you feel, on average?"), providing ratings on a scale from "not at all" (1) to "very much" (5).
Emotional distress as measured by PROMIS Depression Short Form
Time frame: Baseline, 3 Months, 6 Months, 12 Months
Depressive symptoms will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form, an 8-item measure assessing symptoms of depression in the last week. Responses are on a 5-point scale from "never" (1) to "always" (5).
Emotional distress as measured by PROMIS Anxiety Short Form
Time frame: Baseline, 3 Months, 6 Months, 12 Months
Symptoms of Anxiety will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form, an 8-item measure assessing symptoms of anxiety in the last week. Responses are on a 5-point scale from "never" (1) to "always" (5).
Symptom interference as measured by MD Anderson Symptom Inventory (MDASI) Symptom Interference
Time frame: Baseline, 3 Months, 6 Months, 12 Months
The MDASI will be used to assess interference of symptoms in daily living (e.g., working, relations with other people, enjoyment of life) over the past month. The MDASI asks patients to rate the severity of 13 symptoms found frequently in patients with various cancers and treatment types on a scale from 0 (symptom "not present") to 10 (symptom "as bad as you can imagine"). This measure also includes 6 questions asking patients to rate the level of symptom interference in six domains (e.g., general activity, mood) on a scale from 0 (did not interfere) to 10 (interfered completely).
Health care engagement as measured by Patient Participation Questionnaire
Time frame: Baseline, 3 Months, 6 Months, 12 Months
The Patient Participation Questionnaire will be used to assess participants' health care participation and associated domains (i.e., receipt of information, communication, perceptions of their relationship with the medical team). Participants are asked to indicate their agreement with 17 items related to health care engagement on a 4 point scale: "to a great extent," "to some extent," "to a lesser extent," or "not at all." An additional item asks patients about their overall assessment of their involvement in their healthcare.
Patient self-assessment of communication competency with health care providers as measured by Medical Communication Competence Scale (MCCS) patient subscale
Time frame: Baseline, 3 Months, 6 Months, 12 Months
The MCCS patient subscale will be used to assess survivors' perceptions of their competency for communicating and participating in health care. The patient subscale includes 39 items on a scale of 1 to 7, with higher scores reflecting self-perception of better medical communication competence.
4 secondary outcomes
Patient self-efficacy for chronic disease coping as measured by Self-Efficacy for Managing Chronic Illness Scale
Time frame: Baseline, 3 Months, 6 Months, 12 Months
Patient activation as measured by Patient Activation Measure (PAM)
Time frame: Baseline, 3 Months, 6 Months, 12 Months
Patient self-efficacy for managing chronic conditions as measured by the PROMIS Self-Efficacy for Managing Symptoms Short Form
Time frame: Baseline, 3 Months, 6 Months, 12 Months
General patient self-efficacy as measured by the PROMIS General Self-Efficacy Short Form
Time frame: Baseline, 3 Months, 6 Months, 12 Months
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 28 Jan 2026.
- Derived from this study: PubMed 42419501Dorfman CS, Arthur SS, Shelby RA, Stalls JM, Arrato NA, Somers TJ, Wu Y, Thomas SM, Willis MW, Youssef D, Divakaran S, Corbett C, Grilley-Olson J, Oeffinger KC. Symptom management and transitioning to engagement with post-treatment care for adolescent and young adult cancer survivors (AYA STEPS): Study protocol. Contemp Clin Trials. 2026 Jul 8;168:108391. doi: 10.1016/j.cct.2026.108391. Online ahead of print.
- Individual participant dataSharing planned: No. It is the investigators' intention to make all data generated from this proposal freely available after it is de-identified. All direct respondent identifiers (e.g., names and addresses) will be removed and maintained in a secure file for future contact purposes. Respondent identifiers will not be shared. All other scientific data (scale composites) will be both preserved and shared. The following data will be preserved and shared: patient-reported data from study assessments, intervention utilization data collected via the study websites, healthcare utilization data collected from the health record, socio-demographic and medical data collected via patient report and health record, and scores on social determinant of health assessments (e.g., Area Deprivation Index). The investigators will make every effort to provide raw data in a non-proprietary format wherever possible to enhance reproducibility.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AYA Educational Information and AYA STEPS in people with Cancer and Breast Cancer, run by Duke University at 1 site 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 28 Jan 2026. 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 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?
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?
Contact Caroline S Dorfman, PhD (919-416-3473, caroline.dorfman@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity and interference as measured by Brief Pain Inventory (time frame: Baseline, 3 Months, 6 Months, 12 Months). 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?
On the ClinicalTrials.gov record for NCT06371768, 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 28 Jan 2026.