Advanced Solid Tumor CancerEASENCT07636200
The EASE Study: Randomized Trial of a Novel Approach to Addressing Fear of Progression in Advanced Cancer
A study testing Written Exposure-Based Coping Intervention (EASE) in people with Advanced Solid Tumor Cancer and Stage IV Cancer (Solid Tumors Only), run by University of Colorado, Boulder at 2 sites in United States.
Trial summary
Precision oncology has led to a growing population of adults with advanced cancer living increasingly longer lives in the face of profound uncertainty about the future, with over half reporting moderate to high fear of cancer progression (FoP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor Cancer, Stage IV Cancer (Solid Tumors Only), Glioblastoma
- What is being tested?
- Written Exposure-Based Coping Intervention (EASE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 May 2026to May 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, age 18 or older
- Have been diagnosed with either (a) Stage IV metastatic cancer of any solid tumor type, (b) Stage III ovarian cancer that has recurred, (c) 'extensive stage' small cell lung cancer, or (d) glioblastomas of any staging
- Are capable at time of consent of understanding and voluntarily consenting themselves to the study, attending intervention sessions, and writing for 30 minutes, confirmed by an Eastern Cooperative Group Performance Status Scale of ≤2
- Report elevated FoP and cancer-related trauma symptoms on the screening measures: FoP-Q 12-item short version: mean score of 2.5 (or total score of 30), IES-R: mean of 1.5 (or total score of 33)
- Are fluent in English or Spanish and can read English proficiently (for the surveys, which are in English)
Who cannot join
- Patients who have a history of chronic untreated trauma unrelated to their cancer, psychiatric hospitalization or suicide attempt(s) in the past 2 years, or current high suicide risk, as identified in the screening.
- EMR-noted cognitive impairment (such as dementia) is an exclusion due to potential impairments in neural learning mechanisms that may affect the efficacy of exposure therapy.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Joanna Arch, PhD, 720-897-1850, ease@colorado.edu
- Recruiting
University of Colorado Boulder
Boulder, Colorado, 80309
Sarah Genung, 720-897-1850, ease@colorado.edu
Elliot Sandberg, 720-897-1850, ease@colorado.edu
About this study
Precision oncology has led to a growing population of adults with advanced cancer living increasingly longer lives in the face of profound uncertainty about the future, with over half reporting moderate to high fear of cancer progression (FoP). These fears are associated with anxiety and depression, over-use of healthcare, physical symptom burden, higher treatment regret, fatigue, and, in many studies, poorer quality of life. Moreover, FoP is strongly correlated with cancer-related trauma symptoms-physical hyperarousal, intrusiveness of cancer thoughts/images, and avoidance of cancer-related thoughts and feelings, suggesting overlapping symptoms. While behavioral interventions exist to target fear of recurrence in early-stage cancer survivors, there is a dearth of behavioral interventions to address FoP or cancer-related trauma symptoms in adults with advanced cancer, and no known published randomized trials of such interventions in the United States. In addition, cutting-edge developments for the treatment of trauma in general populations have not been adapted to cancer populations. To address these critical gaps, we adapted a cutting-edge behavioral treatment for trauma to reduce FoP and cancer-related trauma symptoms among adults with advanced cancer. The intervention, titled EASE, is based on written exposure therapy, an efficacious approach for reducing trauma symptoms in general populations that is better accepted and far briefer than other gold-standard approaches. EASE adapts this approach to help advanced cancer patients with elevated FoP and cancer-related trauma symptoms reduce their fear of the future by using written exposure focused on their future worst-case scenario with cancer. Informed by the NIH stage model, we evaluated EASE delivered by telehealth in an open pilot trial for 29 adults with late-stage cancer and elevated FoP and cancer-related trauma symptoms. Pilot findings show strong acceptability, feasibility, and efficacy potential. We now propose to conduct the first randomized trial of EASE, and, thus, first known randomized trial in the United States of a behavioral intervention for FoP and cancer-related trauma symptoms among adults with advanced cancer. This 2-arm trial (N=250) will compare EASE delivered by telehealth with Usual Care (UC). We aim to compare EASE to UC on FoP and cancer-related trauma symptoms (primary outcomes) and anxiety, depression, hopelessness, and quality of life, at post-intervention (Aim 1) and follow-up (Aim 2). We will evaluate mechanisms for EASE relative to UC (Aim 3). Offering EASE in both English and Spanish, and by telehealth, increases access. Simple content increases scalability. Rigorous evaluation of EASE has the potential to provide a paradigm-shifting intervention ready for dissemination and to inform evidence-based care guidelines for distressed adults with advanced cancer.
- Conditions
- Advanced Solid Tumor Cancer, Stage IV Cancer (Solid Tumors Only), Glioblastoma, Stage III Ovarian Cancer, Small Cell Lung Cancer Extensive Stage
- Being tested
- Written Exposure-Based Coping Intervention (EASE), Usual Care Control Condition
- Keywords
- Fear of cancer progression, Cancer-related trauma symptoms
- Medical subject headings
- Neoplasms, Glioblastoma, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written Exposure-Based Coping Intervention (EASE)Behavioural
The EASE intervention includes 6-sessions of structured writing designed to reduce fear of progression (FoP) and cancer-related trauma symptoms in adults with advanced cancer. Adapted from Written Exposure Therapy (WET), EASE will be delivered via telehealth by trained interventionists through 1:1 sessions. Each session will last approximately 60 minutes. The first session begins with an assessment, where participants identify their worst-case scenario related to their cancer. In the next three sessions, participants engage in structured exposure writing about this imagined scenario, focusing on vivid, sensory-rich descriptions and thoughts and feelings. The final two sessions involve coping writing, where participants re-evaluate the realism of their scenario. If deemed unlikely, they write about a more realistic outcome and how to cope with it; if likely, they focus on coping strategies for the original scenario
Usual Care Control ConditionBehavioural
Usual Care (UC) consists of access to a clinical social worker and nurse practitioners for supportive visits at patient request. To account for individual and site differences in use/availability of UC resources, patients in both arms will report use of non-study cancer supportive care using piloted trackers.
| Study group | Role | What they receive |
|---|---|---|
| EASE (Written Exposure-Based Coping Intervention) | Experimental | EASE intervention over 6 individual sessions. Receives: Behavioral: Written Exposure-Based Coping Intervention (EASE) |
| Control: Usual Care | Other | Usual Care (UC) consists of access to supportive care providers available at treatment sites. Receives: Behavioral: Usual Care Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of Progression Questionnaire, Short Form (with cancer as the disease)
Assesses fear of cancer progression. Higher scores = higher fear of progression.
Measured: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month follow-up (FU).
Impact of Events Scale-Revised (with cancer as the event)
Cancer-related trauma symptoms. Higher scores = higher symptom levels.
Measured: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month follow-up (FU).
Secondary outcomes (5)
Concerns About Recurrence Scale (CARS overall fear scale)
Fear of cancer recurrence/progression. Higher scores = higher fear of recurrence/progression.
Measured: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month follow-up (FU).
Generalized Anxiety Disorder-7
Anxiety symptoms. Higher scores = higher anxiety symptoms.
Measured: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month follow-up (FU).
Patient Health Questionnaire-8
Depression symptoms. Higher scores = higher depression symptoms.
Measured: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month follow-up (FU).
Hopelessness Assessment in Illness Questionnaire
Hopelessness regarding one's illness. Higher scores = higher hopelessness.
Measured: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month follow-up (FU).
Functional Assessment of Cancer Therapy-General-7 item version (FACT-G7)
Quality of life with cancer. Higher scores = higher quality of life.
Measured: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month 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 posted9 Jun 2026
- Study start4 May 2026
- Primary completionMar 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid Tumor 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
- As the next step in the NIH stage model, we are evaluating EASE in the first known RCT in the US of an intervention tailored for fear of cancer progression and cancer-related trauma symptoms in adults with advanced cancer. Across community and academic clinics, this 2-arm trial (N=250) will compare EASE to Usual Care (UC) among adults with stage IV solid tumor cancer (all types).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Arch, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636200
- Sponsor's protocol ID
- 25-0367
- Other IDs
- 1R01CA300028
- Acronym
- EASE
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study survey data and associated documentation will be made available to the research community free of charge through the Cancer Data Service (CDS), maintained by the National Cancer Institute under the Cancer Research Data Commons (CRDC) infrastructure for storing cancer research data generated by NCI funded programs.
Publications
Arch JJ, Kirk MH, Finkelstein LB. Patient-Reported Worst-Case Scenarios in Advanced Cancer: Presence, Contents, and Predictors. Psychooncology. 2024 Dec;33(12):e70039. doi: 10.1002/pon.70039.
PubMed 39710501Finkelstein LB, Wojdak CP, Studts JL, Arch JJ. Writing Content Predicts Outcomes in Written Exposure to Worst-Case Scenarios for Advanced Cancer. J Palliat Med. 2025 Dec;28(12):1648-1653. doi: 10.1089/jpm.2024.0463. Epub 2025 Jun 12.
PubMed 40510017Arch JJ, Slivjak ET, Finkelstein LB. A Novel Intervention to Reduce Fear of Progression and Trauma Symptoms in Advanced Cancer Using Written Exposure to Worst-Case Scenarios. J Palliat Med. 2024 Aug;27(8):1009-1017. doi: 10.1089/jpm.2023.0658. Epub 2024 Apr 5.
PubMed 38579139
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EASE Study: Randomized Trial of a Novel Approach to Addressing Fear of Progression in Advanced Cancer
- ClinicalTrials.gov ID
- NCT07636200
- Acronym / sponsor ID
- EASE / 25-0367
- Conditions
- Advanced Solid Tumor Cancer, Stage IV Cancer (Solid Tumors Only), Glioblastoma, Stage III Ovarian Cancer, Small Cell Lung Cancer Extensive Stage
- Keywords
- Fear of cancer progression, Cancer-related trauma symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Colorado, Denver
- Study start
- 4 May 2026 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 9 Jun 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.
Precision oncology has led to a growing population of adults with advanced cancer living increasingly longer lives in the face of profound uncertainty about the future, with over half reporting moderate to high fear of cancer progression (FoP). These fears are associated with anxiety and depression, over-use of healthcare, physical symptom burden, higher treatment regret, fatigue, and, in many studies, poorer quality of life. Moreover, FoP is strongly correlated with cancer-related trauma symptoms-physical hyperarousal, intrusiveness of cancer thoughts/images, and avoidance of cancer-related thoughts and feelings, suggesting overlapping symptoms. While behavioral interventions exist to target fear of recurrence in early-stage cancer survivors, there is a dearth of behavioral interventions to address FoP or cancer-related trauma symptoms in adults with advanced cancer, and no known published randomized trials of such interventions in the United States. In addition, cutting-edge developments for the treatment of trauma in general populations have not been adapted to cancer populations. To address these critical gaps, we adapted a cutting-edge behavioral treatment for trauma to reduce FoP and cancer-related trauma symptoms among adults with advanced cancer. The intervention, titled EASE, is based on written exposure therapy, an efficacious approach for reducing trauma symptoms in general populations that is better accepted and far briefer than other gold-standard approaches. EASE adapts this approach to help advanced cancer patients with elevated FoP and cancer-related trauma symptoms reduce their fear of the future by using written exposure focused on their future worst-case scenario with cancer. Informed by the NIH stage model, we evaluated EASE delivered by telehealth in an open pilot trial for 29 adults with late-stage cancer and elevated FoP and cancer-related trauma symptoms. Pilot findings show strong acceptability, feasibility, and efficacy potential. We now propose to conduct the first randomized trial of EASE, and, thus, first known randomized trial in the United States of a behavioral intervention for FoP and cancer-related trauma symptoms among adults with advanced cancer. This 2-arm trial (N=250) will compare EASE delivered by telehealth with Usual Care (UC). We aim to compare EASE to UC on FoP and cancer-related trauma symptoms (primary outcomes) and anxiety, depression, hopelessness, and quality of life, at post-intervention (Aim 1) and follow-up (Aim 2). We will evaluate mechanisms for EASE relative to UC (Aim 3). Offering EASE in both English and Spanish, and by telehealth, increases access. Simple content increases scalability. Rigorous evaluation of EASE has the potential to provide a paradigm-shifting intervention ready for dissemination and to inform evidence-based care guidelines for distressed adults with advanced cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- As the next step in the NIH stage model, we are evaluating EASE in the first known RCT in the US of an intervention tailored for fear of cancer progression and cancer-related trauma symptoms in adults with advanced cancer. Across community and academic clinics, this 2-arm trial (N=250) will compare EASE to Usual Care (UC) among adults with stage IV solid tumor cancer (all types).
| Arm | Type | Receives |
|---|---|---|
| EASE (Written Exposure-Based Coping Intervention) | Experimental | Behavioral: Written Exposure-Based Coping Intervention (EASE)EASE intervention over 6 individual sessions. |
| Control: Usual Care | Other | Behavioral: Usual Care Control ConditionUsual Care (UC) consists of access to supportive care providers available at treatment sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults, age 18 or older
- Have been diagnosed with either (a) Stage IV metastatic cancer of any solid tumor type, (b) Stage III ovarian cancer that has recurred, (c) 'extensive stage' small cell lung cancer, or (d) glioblastomas of any staging
- Are capable at time of consent of understanding and voluntarily consenting themselves to the study, attending intervention sessions, and writing for 30 minutes, confirmed by an Eastern Cooperative Group Performance Status Scale of ≤2
- Report elevated FoP and cancer-related trauma symptoms on the screening measures: FoP-Q 12-item short version: mean score of 2.5 (or total score of 30), IES-R: mean of 1.5 (or total score of 33)
- Are fluent in English or Spanish and can read English proficiently (for the surveys, which are in English)
Key exclusion criteria (2 listed)
- Patients who have a history of chronic untreated trauma unrelated to their cancer, psychiatric hospitalization or suicide attempt(s) in the past 2 years, or current high suicide risk, as identified in the screening.
- EMR-noted cognitive impairment (such as dementia) is an exclusion due to potential impairments in neural learning mechanisms that may affect the efficacy of exposure therapy.
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 |
|---|---|---|
| Written Exposure-Based Coping Intervention (EASE)The EASE intervention includes 6-sessions of structured writing designed to reduce fear of progression (FoP) and cancer-related trauma symptoms in adults with advanced cancer. Adapted from Written Exposure Therapy (WET), EASE will be delivered via telehealth by trained interventionists through 1:1 sessions. Each session will last approximately 60 minutes. The first session begins with an assessment, where participants identify their worst-case scenario related to their cancer. In the next three sessions, participants engage in structured exposure writing about this imagined scenario, focusing on vivid, sensory-rich descriptions and thoughts and feelings. The final two sessions involve coping writing, where participants re-evaluate the realism of their scenario. If deemed unlikely, they write about a more realistic outcome and how to cope with it; if likely, they focus on coping strategies for the original scenario | Behavioural | EASE (Written Exposure-Based Coping Intervention) |
| Usual Care Control ConditionUsual Care (UC) consists of access to a clinical social worker and nurse practitioners for supportive visits at patient request. To account for individual and site differences in use/availability of UC resources, patients in both arms will report use of non-study cancer supportive care using piloted trackers. | Behavioural | Control: Usual Care |
Primary outcome
Fear of Progression Questionnaire, Short Form (with cancer as the disease)
Time frame: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month follow-up (FU).
Assesses fear of cancer progression. Higher scores = higher fear of progression.
Impact of Events Scale-Revised (with cancer as the event)
Time frame: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month follow-up (FU).
Cancer-related trauma symptoms. Higher scores = higher symptom levels.
5 secondary outcomes
Concerns About Recurrence Scale (CARS overall fear scale)
Time frame: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month follow-up (FU).
Generalized Anxiety Disorder-7
Time frame: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month follow-up (FU).
Patient Health Questionnaire-8
Time frame: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month follow-up (FU).
Hopelessness Assessment in Illness Questionnaire
Time frame: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month follow-up (FU).
Functional Assessment of Cancer Therapy-General-7 item version (FACT-G7)
Time frame: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month follow-up (FU).
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 9 Jun 2026.
- Background: PubMed 39710501Arch JJ, Kirk MH, Finkelstein LB. Patient-Reported Worst-Case Scenarios in Advanced Cancer: Presence, Contents, and Predictors. Psychooncology. 2024 Dec;33(12):e70039. doi: 10.1002/pon.70039.
- Background: PubMed 40510017Finkelstein LB, Wojdak CP, Studts JL, Arch JJ. Writing Content Predicts Outcomes in Written Exposure to Worst-Case Scenarios for Advanced Cancer. J Palliat Med. 2025 Dec;28(12):1648-1653. doi: 10.1089/jpm.2024.0463. Epub 2025 Jun 12.
- Background: PubMed 38579139Arch JJ, Slivjak ET, Finkelstein LB. A Novel Intervention to Reduce Fear of Progression and Trauma Symptoms in Advanced Cancer Using Written Exposure to Worst-Case Scenarios. J Palliat Med. 2024 Aug;27(8):1009-1017. doi: 10.1089/jpm.2023.0658. Epub 2024 Apr 5.
- Individual participant dataSharing planned: Yes. De-identified study survey data and associated documentation will be made available to the research community free of charge through the Cancer Data Service (CDS), maintained by the National Cancer Institute under the Cancer Research Data Commons (CRDC) infrastructure for storing cancer research data generated by NCI funded programs.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written Exposure-Based Coping Intervention (EASE) in people with Advanced Solid Tumor Cancer and Stage IV Cancer (Solid Tumors Only), run by University of Colorado, Boulder 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 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 9 Jun 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of Progression Questionnaire, Short Form (with cancer as the disease) (time frame: Assessed four times with parallel timing in the control group: prior to the intervention (Pre), following session 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 3-month follow-up (FU).). 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?
On the ClinicalTrials.gov record for NCT07636200, 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 9 Jun 2026.