NCT07236437|Not Yet RecruitingFDA Device
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Sponsor study identifier
interventional
50
1 country
1
Study Start
November 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 30, 2025
Actual (reported)November 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 19, 2025
Actual (reported)November 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
From baseline assessment to 6-month time point.
Study participants total healthcare costs from baseline to 3-months compared to controls.
From baseline to 3-month time point.
The intervention arm will participate in the Living Well app modules and telecoaching sessions.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Scott Irwin, MD
Cedars-Sinai Medical Center
First Submitted
October 30, 2025
First Posted
November 19, 2025
Study Start
November 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
SilverCloud as a School-Based Intervention for Vulnerable Youth
Study participants total number of healthcare utilization events from baseline to 3-months compared to controls.
From baseline assessment to 3-month time point.
Changes in study participant's anxiety scores from baseline to 3 months.
From baseline to 3 months time point.
Study participants total healthcare costs from baseline to 12-months compared to controls.
From baseline to 12-month time point.
Study participants total number of healthcare utilization events from baseline to 6-months compared to controls.
From baseline to 6-month time point.
Contact the study team to confirm eligibility.
Primary Completion
November 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 19, 2025
Record last verified: 2025-11
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Source: ClinicalTrials.gov.
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