N/A
Completed N=310
Mobile Apps to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design
Depression, Anxiety · Engagement, Patient
Source: ClinicalTrials.gov NCT04583891 ↗
Enrolled (actual)
310
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Patient Health Questionnaire-8 — 12.1; 11.8; 12.5; 12.7 score on a scale
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Health Questionnaire-8 |
6.7; 7.4; 6.6; 8.3 | — |
| PRIMARY Generalized Anxiety Disorder-7 |
5.7; 6.0; 7.2; 7.5 | — |
| SECONDARY App Engagement From App Sessions |
12; 6; 7; 2; 9; 4 | — |
| SECONDARY App Engagement From App Session Duration |
— | — |
| SECONDARY App Engagement From App Downloads |
— | — |
| SECONDARY 36-Item Short Form Survey - Physical Health |
65.9; 52.3; 56.0; 56.8 | — |
| SECONDARY 36-Item Short Form Survey - Mental Health |
68.7; 66.2; 64.5; 63.1 | — |
| SECONDARY Multidimensional Fatigue Symptom Inventory-Short Form |
19.7; 24.0; 20.5; 25.8 | — |
| SECONDARY Pittsburgh Sleep Quality Index |
8.7; 9.6; 8.0; 9.5 | — |
| SECONDARY Alcohol Use Disorders Identification Test |
2.0; 3.7; 1.7; 1.7 | — |
| SECONDARY PROMIS Global Mental Health v1.2 |
45.5; 45.2; 44.8; 42.6 | — |
| SECONDARY PROMIS Satisfaction With Sex Life |
10.6; 10.4; 12.0; 10.5 | — |
| SECONDARY UAMS Health Literacy Measure |
10.6; 10.6; 10.4; 10.7 | — |
| SECONDARY Penn State Worry Questionnaire |
48.8; 49.4; 51.9; 54.4 | — |
| SECONDARY Ten Item Personality Inventory- Extraversion |
8.0; 8.1; 8.8; 7.4 | — |
| SECONDARY Ten Item Personality Inventory - Extraversion |
8.3; 7.9; 8.8; 8.0 | — |
| SECONDARY Ten Item Personality Inventory - Agreeableness |
11.2; 10.7; 10.6; 11.0 | — |
| SECONDARY Ten Item Personality Inventory - Conscientiousness |
11.2; 11.0; 10.0; 11.1 | — |
| SECONDARY Ten Item Personality Inventory - Neuroticism |
9.5; 8.9; 8.3; 8.4 | — |
| SECONDARY Ten Item Personality Inventory - Openness |
10.4; 10.0; 10.2; 10.2 | — |
| SECONDARY TWente Engagement With Ehealth Technologies Scale (TWEETS) |
— | — |
Eligibility Criteria
Inclusion Criteria
- age ≥ 18 years (age 19 if in Nebraska, given age of consent);
- 0-5 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.
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT04583891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.