SurvivorshipmHealthAYANCT05905250
mHealth for Young Adult Cancer Survivors
A study testing an empirically supported protocol, further refined with evidence-based strategies and Health education in people with Survivorship and Cancer, run by George Washington University at 1 site in United States.
Trial summary
We aim to refine and pilot test an 8-week phone- and app-based intervention to promote hope, and thereby mitigate life disruption caused by cancer diagnosis and treatment, among young adults (YAs); our proposal involves (Aim 1) formative research among YA survivors and healthcare providers; and (Aim 2) an randomized… Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Survivorship, Cancer, Psychological Well-Being
- What is being tested?
- an empirically supported protocol, further refined with evidence-based strategies and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2024to 28 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 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of stage I-IV cancer from age 18-39
- Completion of curative treatment (surgery, chemotherapy and/or radiation) within three years of study enrollment
- No significant psychological disabilities
- Able to complete forms and understand instructions in English
- Smartphone access
- Aim 2: Able to commit to 8-week remotely delivered study
Who cannot join
- Completion of curative treatment (surgery, chemotherapy and/or radiation) over three years ago or currently in treatment
- Significant psychological disabilities
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University
Washington D.C., District of Columbia, 20052
About this study
Official title: An mHealth Positive Psychology Intervention to Reduce Cancer Burden in Young Adult Cancer Survivors
We aim to refine and pilot test an 8-week phone- and app-based intervention to promote hope, and thereby mitigate life disruption caused by cancer diagnosis and treatment, among young adults (YAs); our proposal involves (Aim 1) formative research among YA survivors and healthcare providers; and (Aim 2) an randomized controlled trial (RCT) of the intervention vs. attention control among 150 YA cancer survivors. The proposed research is innovative in its use of: 1) a novel intervention target - hope - as a mechanism for addressing goal-disruption and quality of life (QOL) among YA survivors; and 2) novel mHealth components and population-based recruitment strategy (via social media) that are particularly relevant to YA survivors and those with potentially limited access to healthcare. This proposal has potential high impact due to the number of YA cancer survivors for whom the intervention may be relevant, the intervention's potential utility in enhancing hope and QOL among YAs, and its reach/scalability.
Read the detailed description
Young adulthood (YA) is a critical time in shaping life trajectories related to educational, financial, and family goals, among others. Unfortunately, cancer diagnosis/treatment and its psychosocial sequelae disrupt this critical period for some YAs. This life goal disturbance is related to poorer psychological outcomes, particularly among YAs; however, goal revision and reprioritization lead to more positive psychological outcomes. Thus, goal negotiation is a critical part of survivorship. Understanding psychosocial determinants of positive psychological and behavioral outcomes is critical for developing effective behavioral interventions. Within the rich positive psychology literature, the construct of hope is one particularly relevant factor for YA cancer survivors; hope has been defined as a positive cognitive state based on a sense of successful goal-directed determination and planning to meet these goals. In the general population and in cancer survivors, hope is related to better quality of life (QOL), mental health, health behaviors, and coping with illness/cancer. Our team pioneered an mHealth intervention (i.e., app-based with phone-based counseling) aimed at increasing hope among YA survivors, thereby re-engaging them in long-term life goals across domains (e.g., vocational, familial) and ultimately increasing QOL. In an 8-week pilot randomized controlled trial (RCT) of 56 YAs recruited from 2 cancer centers, the intervention demonstrated feasibility (95% retention), acceptability (e.g., high satisfaction), and promising trends in changes in hope, QOL, depressive symptoms, and health behaviors (e.g., substance use) in YA survivors. This study builds on our prior work to update the intervention (e.g., its technology), enhance its reach, and increase our ability to examine its effects. Our specific aims are to: 1) conduct formative research examining YA cancer survivor preferences on phone-based counseling with app support to enhance the intervention; and 2) test the feasibility, acceptability, and preliminary efficacy of the intervention vs. attention control (AC) via an 8-week RCT of 150 YA cancer survivors. The proposed research is innovative in its use of a novel intervention target - hope - as a mechanism for addressing goal-disruption and QOL among YA survivors, and its use of novel mHealth components and population-based recruitment strategy (via social media) that are particularly relevant to YA survivors and those with potentially limited access to healthcare.
- Conditions
- Survivorship, Cancer, Psychological Well-Being
- Being tested
- an empirically supported protocol, further refined with evidence-based strategies, Health education
- Medical subject headings
- Neoplasms, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an empirically supported protocol, further refined with evidence-based strategiesBehavioural
The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.
Health educationBehavioural
Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature. Receives: Behavioral: an empirically supported protocol, further refined with evidence-based strategies |
| Attention Control | Active comparator | Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations. Receives: Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Number of Participants with Retention at End of Treatment
Measured: 2 months (end-of-treatment; EOT)
Retention
Number of Participants with Retention at End of Study
Measured: 4 months (follow-up; FU)
Adherence
Adherence to intervention (number of sessions completed out of 8)
Measured: 2 months (end-of-treatment; EOT)
Acceptability
>75% participants reporting high satisfaction (3 or 4 on scale of 0=not at all to 4=very)
Measured: 2 months (end-of-treatment; EOT)
Acceptability
>75% report yes to "would you recommend this program to your friends who are cancer survivors?"
Measured: 2 months (end-of-treatment; EOT)
Hope
Hope, per Snyder's Adult Hope Scale - a 12-item measure, each scored on a 1-8 scale; 8 items assess hope-related factors (4 are distractor/filler items), for a total score range of 8-64. Higher scores indicate higher hope (better outcome).
Measured: 4 months (follow-up; FU)
Secondary outcomes (7)
Hope
Hope, per Snyder's Adult Hope Scale - a 12-item measure, each scored on a 1-8 scale; 8 items assess hope-related factors (4 are distractor/filler items), for a total score range of 8-64. Higher scores indicate higher hope (better outcome).
Measured: 2 months (end-of-treatment; EOT)
Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale
Higher scores indicate higher Quality of Life (QOL; scale 0-100) (PMCID: PMC2724630); mean scores across QOL dimensions (physical functioning, social functioning, pain interference, fatigue, sleep disturbance, anxiety, depression)
Measured: 2 months (end-of-treatment; EOT)
Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale
Higher scores indicate higher Quality of Life (QOL; scale 0-100) (PMCID: PMC2724630); mean score across QOL dimensions (physical functioning, social functioning, pain interference, fatigue, sleep disturbance, anxiety, depression)
Measured: 4 months (follow-up; FU)
Functional Assessment of Cancer Therapy - General (FACT-G)
Higher scores indicate higher Quality of Life (QOL; scale: 0-108) (https://www.facit.org/measures/fact-g)
Measured: 2 months (end-of-treatment; EOT)
Functional Assessment of Cancer Therapy - General (FACT-G)
Higher scores indicate higher Quality of Life (QOL; scale: 0-108) (https://www.facit.org/measures/fact-g)
Measured: 4 months (follow-up; FU)
Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (2-month)
Higher scores indicate lower anxiety and depressive symptoms (scale 0-100); mean score of across anxiety and depressive symptom subscales
Measured: 2 months (end-of-treatment; EOT)
Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (4-month)
Higher scores indicate lower anxiety and depressive symptoms (scale 0-100); mean score of across anxiety and depressive symptom subscales
Measured: 4 months (follow-up; FU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start15 Mar 2024
- Primary completion28 Feb 2025
- Study completion28 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 (3)Papers the sponsor has linked to this study.
- Other trials for SurvivorshipStudies of the same condition, open and under way.
- More trials run by George Washington 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
- Individual randomized control trial with 1:1 randomization
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Carla Berg, George Washington University
- Investigators
- Carla J Berg, PhD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905250
- Sponsor's protocol ID
- NCR224269
- Other IDs
- R21CA261884
- Acronym
- mHealthAYA
- Status last verified
- Dec 2025
- First submitted
- 26 May 2023
- Last updated
- 16 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berg CJ, McCready DM, Hinds PS, Lyon ME, Dennis K, Howlader A, Bhanot P, Shajan S, Chalasani P, Chitalia A, Arem H. Outcomes of a Randomized Controlled Trial Testing the Feasibility, Acceptability and Preliminary Efficacy of a Digital, Coach-Assisted Intervention to Enhance Hope and Quality of Life Among Young Adult Cancer Survivors. Psychooncology. 2025 Nov;34(11):e70315. doi: 10.1002/pon.70315.
PubMed 41170949Berg CJ, Schubel LC, McCready DM, Shajan S, Bhanot P, Dopke C, Howlader A, Hinds PS, Levine J, Lyon ME, Chalasani P, Arem H. Profiles of quality of life among US young adult cancer survivors and their associations with potential psychosocial intervention targets of hope and psychological flexibility. Qual Life Res. 2025 Sep;34(9):2677-2688. doi: 10.1007/s11136-025-04010-0. Epub 2025 Jun 28.
PubMed 40580382McCready DM, Arem H, Duarte DA, Dennis K, Ball N, Cafferty LA, Hinds PS, Howlader A, Berg CJ. A digital, coach-assisted intervention to address the psychosocial needs of young adult cancer survivors: Randomized controlled trial protocol and intervention adaptation process. Contemp Clin Trials. 2024 Jun;141:107545. doi: 10.1016/j.cct.2024.107545. Epub 2024 Apr 23.
PubMed 38657732
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An mHealth Positive Psychology Intervention to Reduce Cancer Burden in Young Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT05905250
- Acronym / sponsor ID
- mHealthAYA / NCR224269
- Conditions
- Survivorship, Cancer, Psychological Well-Being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Posted 24 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We aim to refine and pilot test an 8-week phone- and app-based intervention to promote hope, and thereby mitigate life disruption caused by cancer diagnosis and treatment, among young adults (YAs); our proposal involves (Aim 1) formative research among YA survivors and healthcare providers; and (Aim 2) an randomized controlled trial (RCT) of the intervention vs. attention control among 150 YA cancer survivors. The proposed research is innovative in its use of: 1) a novel intervention target - hope - as a mechanism for addressing goal-disruption and quality of life (QOL) among YA survivors; and 2) novel mHealth components and population-based recruitment strategy (via social media) that are particularly relevant to YA survivors and those with potentially limited access to healthcare. This proposal has potential high impact due to the number of YA cancer survivors for whom the intervention may be relevant, the intervention's potential utility in enhancing hope and QOL among YAs, and its reach/scalability.
Detailed description
Young adulthood (YA) is a critical time in shaping life trajectories related to educational, financial, and family goals, among others. Unfortunately, cancer diagnosis/treatment and its psychosocial sequelae disrupt this critical period for some YAs. This life goal disturbance is related to poorer psychological outcomes, particularly among YAs; however, goal revision and reprioritization lead to more positive psychological outcomes. Thus, goal negotiation is a critical part of survivorship. Understanding psychosocial determinants of positive psychological and behavioral outcomes is critical for developing effective behavioral interventions. Within the rich positive psychology literature, the construct of hope is one particularly relevant factor for YA cancer survivors; hope has been defined as a positive cognitive state based on a sense of successful goal-directed determination and planning to meet these goals. In the general population and in cancer survivors, hope is related to better quality of life (QOL), mental health, health behaviors, and coping with illness/cancer. Our team pioneered an mHealth intervention (i.e., app-based with phone-based counseling) aimed at increasing hope among YA survivors, thereby re-engaging them in long-term life goals across domains (e.g., vocational, familial) and ultimately increasing QOL. In an 8-week pilot randomized controlled trial (RCT) of 56 YAs recruited from 2 cancer centers, the intervention demonstrated feasibility (95% retention), acceptability (e.g., high satisfaction), and promising trends in changes in hope, QOL, depressive symptoms, and health behaviors (e.g., substance use) in YA survivors. This study builds on our prior work to update the intervention (e.g., its technology), enhance its reach, and increase our ability to examine its effects. Our specific aims are to: 1) conduct formative research examining YA cancer survivor preferences on phone-based counseling with app support to enhance the intervention; and 2) test the feasibility, acceptability, and preliminary efficacy of the intervention vs. attention control (AC) via an 8-week RCT of 150 YA cancer survivors. The proposed research is innovative in its use of a novel intervention target - hope - as a mechanism for addressing goal-disruption and QOL among YA survivors, and its use of novel mHealth components and population-based recruitment strategy (via social media) that are particularly relevant to YA survivors and those with potentially limited access to healthcare.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Individual randomized control trial with 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: an empirically supported protocol, further refined with evidence-based strategiesThe intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature. |
| Attention Control | Active comparator | Behavioral: Health educationHealth education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosis of stage I-IV cancer from age 18-39
- Completion of curative treatment (surgery, chemotherapy and/or radiation) within three years of study enrollment
- No significant psychological disabilities
- Able to complete forms and understand instructions in English
- Smartphone access
Key exclusion criteria (2 listed)
- Completion of curative treatment (surgery, chemotherapy and/or radiation) over three years ago or currently in treatment
- Significant psychological disabilities
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 |
|---|---|---|
| an empirically supported protocol, further refined with evidence-based strategiesThe intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature. | Behavioural | Intervention |
| Health educationHealth education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations. | Behavioural | Attention Control |
Primary outcome
Retention
Time frame: 2 months (end-of-treatment; EOT)
Number of Participants with Retention at End of Treatment
Retention
Time frame: 4 months (follow-up; FU)
Number of Participants with Retention at End of Study
Adherence
Time frame: 2 months (end-of-treatment; EOT)
Adherence to intervention (number of sessions completed out of 8)
Acceptability
Time frame: 2 months (end-of-treatment; EOT)
>75% participants reporting high satisfaction (3 or 4 on scale of 0=not at all to 4=very)
Acceptability
Time frame: 2 months (end-of-treatment; EOT)
>75% report yes to "would you recommend this program to your friends who are cancer survivors?"
Hope
Time frame: 4 months (follow-up; FU)
Hope, per Snyder's Adult Hope Scale - a 12-item measure, each scored on a 1-8 scale; 8 items assess hope-related factors (4 are distractor/filler items), for a total score range of 8-64. Higher scores indicate higher hope (better outcome).
7 secondary outcomes
Hope
Time frame: 2 months (end-of-treatment; EOT)
Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale
Time frame: 2 months (end-of-treatment; EOT)
Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale
Time frame: 4 months (follow-up; FU)
Functional Assessment of Cancer Therapy - General (FACT-G)
Time frame: 2 months (end-of-treatment; EOT)
Functional Assessment of Cancer Therapy - General (FACT-G)
Time frame: 4 months (follow-up; FU)
Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (2-month)
Time frame: 2 months (end-of-treatment; EOT)
Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (4-month)
Time frame: 4 months (follow-up; FU)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41170949Berg CJ, McCready DM, Hinds PS, Lyon ME, Dennis K, Howlader A, Bhanot P, Shajan S, Chalasani P, Chitalia A, Arem H. Outcomes of a Randomized Controlled Trial Testing the Feasibility, Acceptability and Preliminary Efficacy of a Digital, Coach-Assisted Intervention to Enhance Hope and Quality of Life Among Young Adult Cancer Survivors. Psychooncology. 2025 Nov;34(11):e70315. doi: 10.1002/pon.70315.
- Derived from this study: PubMed 40580382Berg CJ, Schubel LC, McCready DM, Shajan S, Bhanot P, Dopke C, Howlader A, Hinds PS, Levine J, Lyon ME, Chalasani P, Arem H. Profiles of quality of life among US young adult cancer survivors and their associations with potential psychosocial intervention targets of hope and psychological flexibility. Qual Life Res. 2025 Sep;34(9):2677-2688. doi: 10.1007/s11136-025-04010-0. Epub 2025 Jun 28.
- Derived from this study: PubMed 38657732McCready DM, Arem H, Duarte DA, Dennis K, Ball N, Cafferty LA, Hinds PS, Howlader A, Berg CJ. A digital, coach-assisted intervention to address the psychosocial needs of young adult cancer survivors: Randomized controlled trial protocol and intervention adaptation process. Contemp Clin Trials. 2024 Jun;141:107545. doi: 10.1016/j.cct.2024.107545. Epub 2024 Apr 23.
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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.
Carla J Berg, PhD principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing an empirically supported protocol, further refined with evidence-based strategies and Health education in people with Survivorship and Cancer, run by George Washington 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 6 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: finished, as of the sponsor's last update on 16 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?
Yes. Results are posted in the registry (first posted 24 Dec 2025). 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?
Retention (time frame: 2 months (end-of-treatment; EOT)). The study lists 6 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 NCT05905250, which also lists 3 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 16 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.