AnxietyNCT07236437
Living Well Program: Impact on Healthcare Costs and Clinical Outcomes in Breast Cancer Care
A study testing Living Well Program in people with Anxiety and Supportive Care in Cancer, run by Scott A. Irwin, MD, PhD at 1 site in United States.
Trial summary
The goal of this study is to evaluate the efficacy and cost-effectiveness of the Living Well Program, a digital therapeutic application with telecoaching support, in breast cancer patients with moderate-to-severe anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, Supportive Care in Cancer, Depression
- What is being tested?
- Living Well Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2025to 15 Nov 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+
- First time breast cancer diagnosis
- Established with a Cedars-Sinai Surgical or Medical Oncologist for cancer care and is within 30 days of starting or having started adjuvant or neoadjuvant therapy
- Prognosis of greater than 1 year
- Breast cancer staging of II-IV
- Moderate to severe anxiety (GAD-7 >= 10)
Show all 9Show fewer
- English language proficiency
- Smartphone and ability to use the application as assessed by study staff (IG only)
- Signed dated informed consent form (ICF) within 30 days of diagnosis (IG only)
Who cannot join
- Prior history of different cancer diagnosis or recurrence of the same cancer
- Serious mental illness evidenced by patient self-report, chart review and/or diagnosis codes
- Presence of suicidal ideation as measured by the Ask Suicide-Screening Questions (ASQ) or a history of suicide attempts as evidenced by self-report or chart review
- Current active addiction (drugs, alcohol, etc.) evidenced by Opioid Risk Tool, chart review and/or diagnosis codes
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
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Angelica Alderete, 3104238969, Angelica.Alderete@cshs.org
Scott Irwin, MD
About this study
The goal of this study is to evaluate the efficacy and cost-effectiveness of the Living Well Program, a digital therapeutic application with telecoaching support, in breast cancer patients with moderate-to-severe anxiety. The main question the study aims to answer is: does digital cognitive-behavioral therapy-based interventions decrease the overall healthcare costs of patients with stage II to IV breast cancer?
The study has one group of participants who will use the Living Well app and telecoaching support. This group will be compared to retroactively matched controls. Over 3 months, patients will complete 21 mental health modules and 5 telecoaching sessions. In the following 3 months, they will complete any outstanding telecoaching sessions and modules while still being monitored, even if they finished all modules and sessions in the first 3 months. The 6 months after that will be the follow-up phase. They will still have access to the Living Well app and may continue to use it, and they will complete the same assessment questionnaires as baseline to identify any changes in their overall mental health.
Read the detailed description
This is a prospective, non-randomized, historically controlled interventional study. It will evaluate the effectiveness and healthcare impacts of a digital cognitive-behavioral therapy-based intervention for anxiety in patients with stage II to IV breast cancer. The high prevalence of anxiety among cancer patients with limited access to mental health support drives higher total healthcare costs, healthcare services utilization, and worse clinical outcomes. This is one of the major rationales for the study. There have been promising preliminary results from previous studies of this intervention in reducing anxiety and depression in cancer patients.
There are minimal known potential risk: primarily, the potential for psychological distress associated with responding to questions about health status and employment. Known potential benefits to patients in the intervention group include immediate psychological well-being improvements and decreased anxiety associated with breast cancer diagnosis and treatment. Long term, patients may develop improved coping and emotional regulations skills that persist beyond the study period. These skills may enhance quality of life and improve treatment adherence and outcomes. More broadly, this study may offer societal benefits through an improved understanding of digital therapeutic interventions in oncology care. Economic analyses from this study may provide insights to the cost-effectiveness of digital interventions in healthcare.
This trial utilizes retrospectively matched controls based on key demographic and clinical characteristics as a comparison group to the intervention group.
Use of retrospectively matched controls was chosen due to the nature of the intervention and the target population. Given that the Living Well Program is a digital therapeutic intervention aimed at addressing a significant unmet need in cancer care, it was deemed ethically preferable to offer the intervention to all eligible participants rather than withholding it from a control group.
The intervention consists of 21 modules in the mobile application, and five 20-minute telecoaching sessions. Participants begin with the first module upon enrollment and are asked to complete one module every other day, or as needed, with each module taking 15-30 minutes. This regimen is designed to be completed over a 6-month period, constituting the planned maximum dosage. The 15-30-minute module duration aims to provide meaningful engagement without overburdening patients undergoing cancer treatment. The 3-month active intervention period aligns with typical durations of effective cognitive-behavioral therapy interventions, while extended 12-month access to the application allows for continued support and skill reinforcement. The inclusion of five telecoaching sessions for the first six months provides human support to complement the digital intervention, an approach shown to enhance engagement and outcomes in digital mental health interventions.
The baseline assessment will include comprehensive demographic and medical history questionnaire, treatment history and sociodemographic factors. Patients will complete validated psychometric scales to assess their quality of life and mental health, including the Generalized Anxiety Disorder-7 (GAD-7) to measure anxiety symptoms, Patient Health Questionnaire-9 (PHQ-9) to measure depression symptoms, PROMIS-29 to assess quality of life, and the Edmonton Symptom Assessment System (ESAS) to assess physical symptoms. They will also complete the Cedars-Sinai Wellbeing Screen and 10-Point Distress thermometer. These assessments provide baseline measures of participants overall mental health.
The intervention will be administered through a smartphone app called The Living Well Program. A study team member will assist with installation and configuration of the app so patients can complete modules and engage in telecoaching sessions. Follow-up assessments at 3-, 6-, and 12-months post-baseline will include the same questionnaires as the baseline assessment, collection of healthcare costs and utilization from medical records, assessment of concomitant medications, and evaluation of intervention adherence and engagement metrics from the app.
- Conditions
- Anxiety, Supportive Care in Cancer, Depression
- Being tested
- Living Well Program
- Keywords
- Anxiety, Breast Cancer, Telecoaching, Telehealth, Supportive Care
- Medical subject headings
- Anxiety Disorders, Depression, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living Well ProgramDevice
The intervention is multicomponent, including a mobile application and telecoaching. The mobile application is comprised of 21 modules integrating psychoeducation and cognitive-behavioral therapy principles, designed to be completed in 3 months. Modules require 15-30 minutes to complete and address topics such as breast cancer education, anxiety management, and adaptive coping strategies. Telecoaching services will provide personalized support for cancer patients throughout their treatment. Participants will complete five 20-30 minute telecoaching sessions with qualified mental health professionals over 6 months.
Outcomes will be compared to a retrospective control cohort.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | The intervention arm will participate in the Living Well app modules and telecoaching sessions. Receives: Device: Living Well Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study participants total healthcare costs from enrollment to six months compared to controls.
Healthcare costs will be extracted from electronic medical records. "Healthcare Costs" will include a sum of the costs of the following over a six month timeframe (enrollment to six months): emergency department visits, ICU visits, inpatient hospital charges, unscheduled hospitalizations, hospital days above expected, 30-day readmissions, outpatient visits, diagnostic visits, medications, chemotherapy, immunotherapy, targeted therapies, pathology, imaging, radiation, and any other treatments.
Measured: From baseline assessment to 6-month time point.
Secondary outcomes (11)
Study participants total healthcare costs from baseline to 3-months compared to controls.
Healthcare costs will be extracted from patient's electronic medical records from baseline assessment to three months. They will be compared to controls over the same period.
"Healthcare Costs" will include the cost of the following: emergency department visits, ICU visits, inpatient hospital charges, unscheduled hospitalizations, hospital days above expected, 30-day readmissions, outpatient visits, diagnostic visits, medications, chemotherapy, immunotherapy, targeted therapies, pathology, imaging, radiation, and any other treatments.
Measured: From baseline to 3-month time point.
Study participants total number of healthcare utilization events from baseline to 3-months compared to controls.
Healthcare utilization will be extracted from CS-Link EMR for participants and controls over the same time period. Assessment of utilization measures the number of the following events:
- Emergency department (ED) visits
- Intensive Care Unit (ICU) visits
- Inpatient hospital charges
- Unscheduled hospitalizations
- Hospital days above expected
- 30-day readmissions
- Outpatient visits
- Diagnostic visits
- Medications, chemotherapy, immunotherapy, targeted therapies, pathology, imaging, radiation, and other treatments
Healthcare utilization score will be the total number of healthcare utilization events in the given time period (e.g., 1 emergency department visit and 1 unscheduled hospitalization = healthcare utilization score of 2).
Measured: From baseline assessment to 3-month time point.
Changes in study participant's anxiety scores from baseline to 3 months.
Changes will be measured using the Generalized Anxiety Disorder-7 (GAD-7) assessment for anxiety. Participant's GAD-7 assessment scores at baseline will be compared to GAD-7 score at 3-months time point. A higher GAD-7 score indicates more severe anxiety.
Measured: From baseline to 3 months time point.
Study participants total healthcare costs from baseline to 12-months compared to controls.
Healthcare costs will be extracted from patient's electronic medical records from baseline assessment to 12 months. They will be compared to controls over the same period.
"Healthcare Costs" will include the cost of the following: emergency department visits, ICU visits, inpatient hospital charges, unscheduled hospitalizations, hospital days above expected, 30-day readmissions, outpatient visits, diagnostic visits, medications, chemotherapy, immunotherapy, targeted therapies, pathology, imaging, radiation, and any other treatments.
Measured: From baseline to 12-month time point.
Study participants total number of healthcare utilization events from baseline to 6-months compared to controls.
Healthcare utilization will be extracted from CS-Link EMR for participants and controls over the same time period. Assessment of utilization measures the number of the following events:
- Emergency department (ED) visits
- Intensive Care Unit (ICU) visits
- Inpatient hospital charges
- Unscheduled hospitalizations
- Hospital days above expected
- 30-day readmissions
- Outpatient visits
- Diagnostic visits
- Medications, chemotherapy, immunotherapy, targeted therapies, pathology, imaging, radiation, and other treatments
Healthcare utilization score will be the total number of healthcare utilization events in the given time period (e.g., 1 emergency department visit and 1 unscheduled hospitalization = healthcare utilization score of 2).
Measured: From baseline to 6-month time point.
Study participants total number of healthcare utilization events from baseline to 12-months compared to controls.
Healthcare utilization will be extracted from CS-Link EMR for participants and controls over the same time period. Assessment of utilization measures the number of the following events:
- Emergency department (ED) visits
- Intensive Care Unit (ICU) visits
- Inpatient hospital charges
- Unscheduled hospitalizations
- Hospital days above expected
- 30-day readmissions
- Outpatient visits
- Diagnostic visits
- Medications, chemotherapy, immunotherapy, targeted therapies, pathology, imaging, radiation, and other treatments
Healthcare utilization score will be the total number of healthcare utilization events in the given time period (e.g., 1 emergency department visit and 1 unscheduled hospitalization = healthcare utilization score of 2).
Measured: From baseline to 12-month time point.
Changes to participant's anxiety score from baseline to 6-months.
Changes will be measured using the Generalized Anxiety Disorderr-7 (GAD-7) assessment for anxiety. Participant's GAD-7 assessment scores at baseline will be compared to GAD-7 score at 6-months time point. A higher GAD-7 score indicates more severe anxiety.
Measured: From baseline to 6-months time point.
Changes to study participant's anxiety scores from baseline to 12-months.
Changes will be measured using the Generalized Anxiety Disorder-7 (GAD-7) assessment for anxiety. Participant's GAD-7 assessment scores at baseline will be compared to GAD-7 score at 12-months time point. A higher GAD-7 score indicates more severe anxiety.
Measured: From baseline to 12- months time point.
Study participants changes in depression score from baseline to 3 months.
Changes will be measured using the Patient Health Questionnaire-9 (PHQ-9) assessment for depression. Participant's PHQ-9 assessment scores at baseline will be compared to PHQ-9 score at 3-months time point. A higher PHQ-9 score indicates more severe depression symptoms.
Measured: From baseline to 3-months time point.
Study participants depression score changes from baseline to 6-months.
Changes will be measured using the Patient Health Questionnaire-9 (PHQ-9) assessment for depression. Participant's PHQ-9 assessment scores at baseline will be compared to PHQ-9 score at 6-months time point. A higher PHQ-9 score indicates more severe depression symptoms.
Measured: From baseline to 6-months time point.
Study participants depression score changes over 12- months.
Changes will be measured using the Patient Health Questionnaire-9 (PHQ-9) assessment for depression. Participant's PHQ-9 assessment scores at baseline will be compared to PHQ-9 score at 12-months time point. A higher PHQ-9 score indicates more severe depression symptoms.
Measured: From baseline to 12-months time point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start15 Nov 2025 (estimated)
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study has one, non-randomized treatment arm. The second arm is retrospectively matched controls.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scott A. Irwin, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Prosoma, Cedars-Sinai Medical Center
- Responsible party
- Sponsor-investigator, Scott A. Irwin, MD, PhD, Cedars-Sinai Medical Center
- Investigators
- Scott Irwin, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236437
- Sponsor's protocol ID
- IIT2024-12-Irwin-LivingWell
- Status last verified
- Nov 2025
- First submitted
- 30 Oct 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Well Program: Impact on Healthcare Costs and Clinical Outcomes in Breast Cancer Care
- ClinicalTrials.gov ID
- NCT07236437
- Acronym / sponsor ID
- IIT2024-12-Irwin-LivingWell
- Conditions
- Anxiety, Supportive Care in Cancer, Depression
- Keywords
- Anxiety, Breast Cancer, Telecoaching, Telehealth, Supportive Care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Scott A. Irwin, MD, PhDUniversity, hospital or other
- Collaborators
- Prosoma, Cedars-Sinai Medical Center
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 19 Nov 2025 (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 goal of this study is to evaluate the efficacy and cost-effectiveness of the Living Well Program, a digital therapeutic application with telecoaching support, in breast cancer patients with moderate-to-severe anxiety. The main question the study aims to answer is: does digital cognitive-behavioral therapy-based interventions decrease the overall healthcare costs of patients with stage II to IV breast cancer?
The study has one group of participants who will use the Living Well app and telecoaching support. This group will be compared to retroactively matched controls. Over 3 months, patients will complete 21 mental health modules and 5 telecoaching sessions. In the following 3 months, they will complete any outstanding telecoaching sessions and modules while still being monitored, even if they finished all modules and sessions in the first 3 months. The 6 months after that will be the follow-up phase. They will still have access to the Living Well app and may continue to use it, and they will complete the same assessment questionnaires as baseline to identify any changes in their overall mental health.
Detailed description
This is a prospective, non-randomized, historically controlled interventional study. It will evaluate the effectiveness and healthcare impacts of a digital cognitive-behavioral therapy-based intervention for anxiety in patients with stage II to IV breast cancer. The high prevalence of anxiety among cancer patients with limited access to mental health support drives higher total healthcare costs, healthcare services utilization, and worse clinical outcomes. This is one of the major rationales for the study. There have been promising preliminary results from previous studies of this intervention in reducing anxiety and depression in cancer patients.
There are minimal known potential risk: primarily, the potential for psychological distress associated with responding to questions about health status and employment. Known potential benefits to patients in the intervention group include immediate psychological well-being improvements and decreased anxiety associated with breast cancer diagnosis and treatment. Long term, patients may develop improved coping and emotional regulations skills that persist beyond the study period. These skills may enhance quality of life and improve treatment adherence and outcomes. More broadly, this study may offer societal benefits through an improved understanding of digital therapeutic interventions in oncology care. Economic analyses from this study may provide insights to the cost-effectiveness of digital interventions in healthcare.
This trial utilizes retrospectively matched controls based on key demographic and clinical characteristics as a comparison group to the intervention group.
Use of retrospectively matched controls was chosen due to the nature of the intervention and the target population. Given that the Living Well Program is a digital therapeutic intervention aimed at addressing a significant unmet need in cancer care, it was deemed ethically preferable to offer the intervention to all eligible participants rather than withholding it from a control group.
The intervention consists of 21 modules in the mobile application, and five 20-minute telecoaching sessions. Participants begin with the first module upon enrollment and are asked to complete one module every other day, or as needed, with each module taking 15-30 minutes. This regimen is designed to be completed over a 6-month period, constituting the planned maximum dosage. The 15-30-minute module duration aims to provide meaningful engagement without overburdening patients undergoing cancer treatment. The 3-month active intervention period aligns with typical durations of effective cognitive-behavioral therapy interventions, while extended 12-month access to the application allows for continued support and skill reinforcement. The inclusion of five telecoaching sessions for the first six months provides human support to complement the digital intervention, an approach shown to enhance engagement and outcomes in digital mental health interventions.
The baseline assessment will include comprehensive demographic and medical history questionnaire, treatment history and sociodemographic factors. Patients will complete validated psychometric scales to assess their quality of life and mental health, including the Generalized Anxiety Disorder-7 (GAD-7) to measure anxiety symptoms, Patient Health Questionnaire-9 (PHQ-9) to measure depression symptoms, PROMIS-29 to assess quality of life, and the Edmonton Symptom Assessment System (ESAS) to assess physical symptoms. They will also complete the Cedars-Sinai Wellbeing Screen and 10-Point Distress thermometer. These assessments provide baseline measures of participants overall mental health.
The intervention will be administered through a smartphone app called The Living Well Program. A study team member will assist with installation and configuration of the app so patients can complete modules and engage in telecoaching sessions. Follow-up assessments at 3-, 6-, and 12-months post-baseline will include the same questionnaires as the baseline assessment, collection of healthcare costs and utilization from medical records, assessment of concomitant medications, and evaluation of intervention adherence and engagement metrics from the app.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study has one, non-randomized treatment arm. The second arm is retrospectively matched controls.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: Living Well ProgramThe intervention arm will participate in the Living Well app modules and telecoaching sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18+
- First time breast cancer diagnosis
- Established with a Cedars-Sinai Surgical or Medical Oncologist for cancer care and is within 30 days of starting or having started adjuvant or neoadjuvant therapy
- Prognosis of greater than 1 year
- Breast cancer staging of II-IV
Key exclusion criteria (4 listed)
- Prior history of different cancer diagnosis or recurrence of the same cancer
- Serious mental illness evidenced by patient self-report, chart review and/or diagnosis codes
- Presence of suicidal ideation as measured by the Ask Suicide-Screening Questions (ASQ) or a history of suicide attempts as evidenced by self-report or chart review
- Current active addiction (drugs, alcohol, etc.) evidenced by Opioid Risk Tool, chart review and/or diagnosis codes
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 |
|---|---|---|
| Living Well ProgramThe intervention is multicomponent, including a mobile application and telecoaching. The mobile application is comprised of 21 modules integrating psychoeducation and cognitive-behavioral therapy principles, designed to be completed in 3 months. Modules require 15-30 minutes to complete and address topics such as breast cancer education, anxiety management, and adaptive coping strategies. Telecoaching services will provide personalized support for cancer patients throughout their treatment. Participants will complete five 20-30 minute telecoaching sessions with qualified mental health professionals over 6 months. Outcomes will be compared to a retrospective control cohort. | Device | Intervention Arm |
Primary outcome
Study participants total healthcare costs from enrollment to six months compared to controls.
Time frame: From baseline assessment to 6-month time point.
Healthcare costs will be extracted from electronic medical records. "Healthcare Costs" will include a sum of the costs of the following over a six month timeframe (enrollment to six months): emergency department visits, ICU visits, inpatient hospital charges, unscheduled hospitalizations, hospital days above expected, 30-day readmissions, outpatient visits, diagnostic visits, medications, chemotherapy, immunotherapy, targeted therapies, pathology, imaging, radiation, and any other treatments.
11 secondary outcomes
Study participants total healthcare costs from baseline to 3-months compared to controls.
Time frame: From baseline to 3-month time point.
Study participants total number of healthcare utilization events from baseline to 3-months compared to controls.
Time frame: From baseline assessment to 3-month time point.
Changes in study participant's anxiety scores from baseline to 3 months.
Time frame: From baseline to 3 months time point.
Study participants total healthcare costs from baseline to 12-months compared to controls.
Time frame: From baseline to 12-month time point.
Study participants total number of healthcare utilization events from baseline to 6-months compared to controls.
Time frame: From baseline to 6-month time point.
Study participants total number of healthcare utilization events from baseline to 12-months compared to controls.
Time frame: From baseline to 12-month time point.
Changes to participant's anxiety score from baseline to 6-months.
Time frame: From baseline to 6-months time point.
Changes to study participant's anxiety scores from baseline to 12-months.
Time frame: From baseline to 12- months time point.
Study participants changes in depression score from baseline to 3 months.
Time frame: From baseline to 3-months time point.
Study participants depression score changes from baseline to 6-months.
Time frame: From baseline to 6-months time point.
Study participants depression score changes over 12- months.
Time frame: From baseline to 12-months time point.
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 19 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Scott Irwin, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Living Well Program in people with Anxiety and Supportive Care in Cancer, run by Scott A. Irwin, MD, PhD 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 9 inclusion and 4 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 19 Nov 2025. 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 Angelica Angelica (3104238969, Angelica.Alderete@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study participants total healthcare costs from enrollment to six months compared to controls. (time frame: From baseline assessment to 6-month time point.). 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 19 Nov 2025.