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Living Well Program: Impact on Healthcare Costs and Clinical Outcomes in Breast Cancer Care

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Over 3 months, patients will complete 21 mental health modules and 5 telecoaching sessions."
  • "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."
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the Living Well app and remote coaching improve mental health and lower healthcare costs. It is for adults with stage II to IV breast cancer and moderate to severe anxiety. The app teaches skills to help change unhelpful thoughts and behaviors.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older with a first breast cancer diagnosis.
  • Have stage II to IV breast cancer.
  • Get cancer care from a Cedars-Sinai cancer surgeon or cancer medicine doctor, and be within 30 days before or after starting treatment given before or after surgery.
  • Be expected to live more than 1 year.
  • Have moderate to severe anxiety, with a score of 10 or higher on the GAD-7 anxiety survey.
  • Be able to use English.
  • For the app group only: have a smartphone and be able to use the app, as checked by study staff.
  • For the app group only: sign and date a study consent form within 30 days of diagnosis.

Who can't join

  • Have had another type of cancer, or have breast cancer that has come back.
  • Have a serious mental illness.
  • Have thoughts of suicide on the study screening, or have tried to end your life in the past.
  • Have a current addiction to drugs, alcohol, or other substances.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

CA