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Mobile Apps + Coaching for Breast Cancer Survivors' Distress

N/A
Waitlist Available
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years (age 19 if in Nebraska, given age of consent)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing whether a mobile health intervention can help reduce symptoms of depression and anxiety in breast cancer survivors, and whether coaching can help improve engagement with the intervention.

Who is the study for?
This trial is for female breast cancer survivors diagnosed within the last 5 years, showing signs of depression or anxiety. They must be adults with a specific score on mental health questionnaires and have an app-compatible phone. Those currently adjusting antidepressant doses or with certain mental health conditions are excluded.Check my eligibility
What is being tested?
The study tests IntelliCare mobile apps aimed at reducing emotional distress in breast cancer survivors, comparing them to standard patient education. It also examines if adding human coaching improves engagement and outcomes using a SMART experimental design.See study design
What are the potential side effects?
Since this trial involves psychological interventions through mobile apps and coaching rather than medication, traditional side effects are not expected; however, participants may experience varying levels of emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am at least 18 years old, or 19 if I live in Nebraska.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Generalized Anxiety Disorder-7
Patient Health Questionnaire-8
Secondary outcome measures
36-Item Short Form Survey
Alcohol Use Disorders Identification Test
App Engagement from App Downloads
+10 more
Other outcome measures
Digital Intervention Adherence Questionnaire
Digital Intervention Evaluation Questionnaire
Limited List of Questions for Exit Interview

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IntelliCareExperimental Treatment2 Interventions
IntelliCare is a self-guided, fully automated suite of apps designed for brief, frequent check-ins to promote skill acquisition. IntelliCare has been shown in both general deployment and human-supported trials to be efficacious in reducing symptoms of depression and anxiety.
Group II: Patient EducationActive Control1 Intervention
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IntelliCare
2016
N/A
~560
Coaching
2016
Completed Phase 3
~5600

Find a Location

Who is running the clinical trial?

Northwestern UniversityOTHER
1,585 Previous Clinical Trials
916,917 Total Patients Enrolled
University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,244,717 Total Patients Enrolled

Media Library

IntelliCare Clinical Trial Eligibility Overview. Trial Name: NCT04583891 — N/A
Patient Engagement Research Study Groups: Patient Education, IntelliCare
Patient Engagement Clinical Trial 2023: IntelliCare Highlights & Side Effects. Trial Name: NCT04583891 — N/A
IntelliCare 2023 Treatment Timeline for Medical Study. Trial Name: NCT04583891 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies to join this experiment?

"According to the information provided by clinicaltrials.gov, this particular medical trial is not presently recruiting patients. The research was initially posted on September 27th 2021 and most recently amended on November 21st 2022. Although there are no participants being recruited for this study at present, 2375 other trials require recruits across a variety of diagnoses."

Answered by AI

What are the fundamental goals of this medical experiment?

"The primary outcome of this research, evaluated over the course of 12 months, is centered on Generalized Anxiety Disorder-7. Additionally, conscientousness, openness, agreeableness extraversion and neuroticism are measured by administering Ten Item Personality Inventory; physical and mental health status with 36-Item Short Form Survey; as well as App Engagement from App Sessions to determine number of app sessions completed."

Answered by AI

Who else is applying?

What site did they apply to?
University of Virginia
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

The other thing I found that can help me is a drug called Trazodone.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Mobile Apps to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design
Philip Chow, Ph.D. 2021. "Mobile Apps to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04583891.
~90 spots leftby Apr 2025
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