Mobile Apps to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design
NCT ID: NCT04583891
Last Updated: 2025-11-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
313 participants
INTERVENTIONAL
2021-09-27
2024-01-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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IntelliCare
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.
IntelliCare
IntelliCare is a self-guided, fully automated suite of 6 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.
Coaching
The randomization of added coaching vs. no added coaching after 1 week will only be carried out in the IntelliCare group. Coaching is a human supported approach to optimizing the use and benefit of the IntelliCare apps.
Patient Education
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.
Psychoeducation
The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
Interventions
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IntelliCare
IntelliCare is a self-guided, fully automated suite of 6 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.
Psychoeducation
The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
Coaching
The randomization of added coaching vs. no added coaching after 1 week will only be carried out in the IntelliCare group. Coaching is a human supported approach to optimizing the use and benefit of the IntelliCare apps.
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
FEMALE
No
Sponsors
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Northwestern University
OTHER
National Cancer Institute (NCI)
NIH
University of Virginia
OTHER
Responsible Party
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Philip Chow, Ph.D.
Assistant Professor
Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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200218
Identifier Type: -
Identifier Source: org_study_id