Mobile Apps to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design

NCT04583891 | Completed Results

• 2 other identifiers: 2002181R37CA248434-01A1
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Depression, Anxiety; Engagement, Patient

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (8)

• Patient Health Questionnaire-8

  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.

  Baseline

• Patient Health Questionnaire-8

  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.

  Post 8 weeks

• Patient Health Questionnaire-8

  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.

  6 month follow up

• Patient Health Questionnaire-8

  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.

  12 month follow up

• Generalized Anxiety Disorder-7

  7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.

  Baseline

• Generalized Anxiety Disorder-7

  7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.

  Post 8 weeks

• Generalized Anxiety Disorder-7

  7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.

  6 month follow up

• Generalized Anxiety Disorder-7

  7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.

  12 month follow up

Secondary Outcomes (63)

• App Engagement From App Sessions

  Frequency of unique app sessions from Baseline through 8 weeks

• App Engagement From App Session Duration

  Duration in seconds of app sessions from Baseline through 8 weeks

• App Engagement From App Downloads

  Number of apps downloaded from Baseline through 8 weeks

• 36-Item Short Form Survey - Physical Health

  Baseline

• 36-Item Short Form Survey - Physical Health

  8 week

Other Outcomes (2)

• Digital Intervention Evaluation Questionnaire

  8 weeks

• Digital Intervention Adherence Questionnaire

  8 weeks

Study Arms (2)

IntelliCare

EXPERIMENTAL

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.

Behavioral: IntelliCare; Behavioral: Coaching

Patient Education

ACTIVE COMPARATOR

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.

Behavioral: Psychoeducation

Interventions

IntelliCare BEHAVIORAL

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.

IntelliCare

Psychoeducation BEHAVIORAL

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.

Patient Education

Coaching BEHAVIORAL

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.

IntelliCare

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility is not based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years (age 19 if in Nebraska, given age of consent);
• years post-diagnosis of Stage I, II, or III female breast cancer;
• 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.

You may not qualify if:

• Taking antidepressant medication and have had an appointment to adjust the dosage over the past 2 weeks;
• 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;
• do not have an app-compatible phone (i.e., iOS 10.3 or later or Android 4.0.3 or later);
• cannot read and speak English (current intervention only available in English).

Sponsors & Collaborators

• University of Virginia: lead
• Northwestern University: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Patient Participation; Breast Neoplasms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Technical problems led to not being able to extract app engagement based on app session duration and number of app downloads from any participants. The TWente Engagement With Ehealth Technologies Scale (TWEETS) was not administered as it was redundant with the other intervention evaluation and adherence measures. These have been recorded in the Results by including "0" participants analyzed and providing an explanation in the Analysis Population Description for why data cannot be reported.

Results Point of Contact

• Title: Philip Chow
• Organization: University of Virginia

pic2u@virginia.edu

9146453458

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Sequential, Multiple Assignment, Randomized Trial (SMART)

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: October 12, 2020
• Study Start: September 27, 2021
• Primary Completion: January 16, 2024
• Study Completion: January 16, 2024
• Last Updated: November 10, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)