Clinical trial · Interventional
Living Well Program: Impact on Healthcare Costs and Clinical Outcomes in Breast Cancer Care
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Supportive Care in Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Living Well Program | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention Arm
- description
- The intervention arm will participate in the Living Well app modules and telecoaching sessions.
- interventionNames
- Device: Living Well Program
Primary outcomes (1)
- measure
- Study participants total healthcare costs from enrollment to six months compared to controls.
- timeFrame
- From baseline assessment to 6-month time point.
- description
- 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.
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18+ 2. First time breast cancer diagnosis 3. 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 4. Prognosis of greater than 1 year 5. Breast cancer staging of II-IV 6. Moderate to severe anxiety (GAD-7 \>= 10) 7. English language proficiency 8. Smartphone and ability to use the application as assessed by study staff (IG only) 9. Signed dated informed consent form (ICF) within 30 days of diagnosis (IG only) Exclusion Criteria: 1. Prior history of different cancer diagnosis or recurrence of the same cancer 2. Serious mental illness evidenced by patient self-report, chart review and/or diagnosis codes 3. 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 4. Current active addiction (drugs, alcohol, etc.) evidenced by Opioid Risk Tool, chart review and/or diagnosis codes
References
Publications (0)
Data not yet available