Living Well Program: Impact on Healthcare Costs and Clinical Outcomes in Breast Cancer Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorScott A. Irwin, MD, PhD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Living Well Program
DeviceThe 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Intervention ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From baseline assessment to 6-month time point.Secondary outcomes
1
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.
Time frame
From baseline to 3-month time point.2
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).
Time frame
From baseline assessment to 3-month time point.3
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.
Time frame
From baseline to 3 months time point.4
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.
Time frame
From baseline to 12-month time point.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Scott A. Irwin, MD, PhD
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution
Prosoma
Collaborator
Cedars-Sinai Medical Center
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: