Living Well Program: Impact on Healthcare Costs and Clinical Outcomes in Breast Cancer Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Study participants total healthcare costs from enrollment to six months compared to controls.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
- •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)
排除标准
- •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
研究组 & 干预措施
Intervention Arm
The intervention arm will participate in the Living Well app modules and telecoaching sessions.
干预措施: Living Well Program (Device)
结局指标
主要结局
Study participants total healthcare costs from enrollment to six months compared to controls.
时间窗: 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.
次要结局
- Study participants total healthcare costs from baseline to 3-months compared to controls.(From baseline to 3-month time point.)
- Study participants depression score changes over 12- months.(From baseline to 12-months time point.)
- 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 number of healthcare utilization events from baseline to 6-months compared to controls.(From baseline to 6-month time point.)
- Changes to study participant's anxiety scores from baseline to 12-months.(From baseline to 12- 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 12-months compared to controls.(From baseline to 12-month time point.)
- Changes to participant's anxiety score from baseline to 6-months.(From baseline to 6-months time point.)
- Study participants changes in depression score from baseline to 3 months.(From baseline to 3-months time point.)
- Study participants depression score changes from baseline to 6-months.(From baseline to 6-months time point.)
研究者
Scott A. Irwin, MD, PhD
Principal Investigator
Cedars-Sinai Medical Center