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NCT07236437 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Scott A. Irwin, MD, PhD.

Not yet
Registry status
NA
Development phase
50
Enrollment target

NCT07236437: Clinical Trial NA study, sponsored by Scott A. Irwin, MD, PhD.

NCT07236437 is a NA study that has not yet begun recruiting, run by Scott A. Irwin, MD, PhD. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07236437, a NA study, has not yet begun recruiting, sponsored by Scott A. Irwin, MD, PhD.

NOT YET RECRUITING
Registry status
NA
Development phase
50 participants
Enrollment target

Study Summary

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.

Primary Outcome

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.

Interventions

  • DEVICE Living Well Program

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2025-11-15
Est. Completion 2027-11-15
Phase NA
Scott A. Irwin, MD, PhD

2 total trials

What is known before NCT07236437 opens enrollment

NCT07236437 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which Living Well Program is the first listed.

NCT07236437 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07236437 about?

NCT07236437 is a clinical study titled "Living Well Program: Impact on Healthcare Costs and Clinical Outcomes in Breast Cancer Care". 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-behavior...

What is the current status of trial NCT07236437?

This trial is currently not yet recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2025-11-15. Estimated completion is 2027-11-15.

What interventions are being tested in trial NCT07236437?

The interventions under investigation include: Living Well Program (DEVICE).

Who is sponsoring clinical trial NCT07236437?

This trial is sponsored by Scott A. Irwin, MD, PhD, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07236437's enrollment target sits among peer trials

50 1279th of 2000 higher than 622 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07236437, the US trial registry maintained by the National Library of Medicine. NCT07236437 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.