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Phone app could ease distress in breast cancer survivors

NCT ID NCT04583891

Symptom relief Sponsor: University of Virginia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a mobile app called IntelliCare can reduce depression and anxiety in breast cancer survivors. 313 women who had been diagnosed within the past 5 years and had elevated symptoms used the app or received standard educational materials. The study also looked at whether adding human coaching helped those who used the app less. The goal is to find a low-cost, accessible way to support survivors' mental health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IntelliCare mobile app suite
What this could lead to
If it works, this could provide a simple, scalable way to help breast cancer survivors manage emotional distress using their phone.
What could go wrong
This is a completed study, but it tested a behavioral intervention, not a drug. Results may not apply to all survivors, and the effect may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

313 people

The number who actually took part.

Started

Sep 2021

Finished

Jan 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. age ≥ 18 years (age 19 if in Nebraska, given age of consent); 2. 0-5 years post-diagnosis of Stage I, II, or III female breast cancer; 3. elevated symptoms of depression as measured by the Patient Health Questionnaire-8 (PHQ-8) score ≥ 10 and/or symptoms of anxiety as measured by the Generalized Anxiety Disorder-7 (GAD-7) score ≥ 8. Exclusion Criteria: 1. Taking antidepressant medication and have had an appointment to adjust the dosage over the past 2 weeks; 2. mental health condition deemed to interfere with study procedures or put the participant at undue risk based on self-reported history of psychosis or bipolar disorder, or active suicidal ideation that necessitates more intense care; 3. do not have an app-compatible phone (i.e., iOS 10.3 or later or Android 4.0.3 or later); 4. cannot read and speak English (current intervention only available in English).

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Conditions

The condition(s) this trial relates to.

anxiety disorder breast cancer breast neoplasm Depression mixed anxiety and depressive disorder Patient Participation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression, anxiety Engagement, patient

Contacts and locations

Locations

  • University of Virginia

    Charlottesville, Virginia, 22904, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.