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NCT04583891 · ClinicalTrials.gov registry record · NA
Mobile Apps to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design
A NA study, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 313
- Enrollment target
NCT04583891: Completed NA study, sponsored by University of Virginia.
NCT04583891 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 313 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04583891, a NA study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 313 participants
- Enrollment target
Study Summary
The overarching goals of this project are to provide the first rigorous test of a scalable and publicly accessible mobile health intervention (IntelliCare) to address emotional distress in women with breast cancer, and to test the impact of human coaching as a way to increase engagement with digital health interventions to improve outcomes. To achieve these goals, an innovative experimental study design, known as a Sequential, Multiple Assignment, Randomized Trial (SMART), will be used to test the effects of the IntelliCare apps on symptoms of depression and anxiety, as well as the added value of human support to improve participant engagement. 313 breast cancer survivors diagnosed within the past 5 years and who screen positive for elevated symptoms of depression and/or anxiety will be recruited. Participants will initially be randomized to receive the IntelliCare apps or app-delivered patient education (control) for 8 weeks, and the impact of the IntelliCare apps on reducing symptoms of depression and anxiety in breast cancer survivors relative to control will be tested (Aim 1). We will monitor the app usage data of participants who receive the IntelliCare apps. Those who are high-engagers will continue to use the apps with no change. Those who are low-to-moderate engagers will be rerandomized after 1 week to either receive added coaching vs. not (i.e., no change) in addition to the apps. The hypothesis is that added coaching to address barriers to app usage will lead to greater engagement with the apps (Aim 2), for low-to-moderate engagers. Finally, semi-structured exit interviews will be conducted with participants that receive the IntelliCare apps and coaching. Interviews will capture survivors' perceptions about the extent to which, and how, tailoring the apps and coaching specifically for breast cancer survivors may improve intervention outcomes and engagement (Aim 3).
Primary Outcome
8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.
Interventions
- BEHAVIORAL Psychoeducation
- BEHAVIORAL IntelliCare
- BEHAVIORAL Coaching
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 313 participants |
| Start Date | 2021-09-27 |
| Est. Completion | 2024-01-16 |
| Phase | NA |
What the finished NCT04583891 record still lists
NCT04583891 is an interventional study that assigns participants to a tested intervention. The registered 313 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 3 interventions - of which Psychoeducation is the first listed.
NCT04583891 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04583891 about?
NCT04583891 is a clinical study titled "Mobile Apps to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design". The overarching goals of this project are to provide the first rigorous test of a scalable and publicly accessible mobile health intervention (IntelliCare) to address emotional distress in women with breast cancer, and to test the impact of human coaching as a way to increase engagement with digital...
What is the current status of trial NCT04583891?
This trial is currently completed. It is a NA study. The enrollment target is 313 participants. The study started on 2021-09-27. Estimated completion is 2024-01-16.
What interventions are being tested in trial NCT04583891?
The interventions under investigation include: Psychoeducation (BEHAVIORAL), IntelliCare (BEHAVIORAL), Coaching (BEHAVIORAL).
Who is sponsoring clinical trial NCT04583891?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04583891's enrollment target sits among peer trials
313 323rd of 2000 higher than 1,678 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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