Clinical trial NCT04583891: Mobile Apps to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design
Official title: Evaluating a Mobile Application to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Engagement, Patient
Keywords: Breast Cancer
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: National Cancer Institute (NCI)
First posted: 2020-10-12
Enrollment: 313
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Sequential, Multiple Assignment, Randomized Trial (SMART)
Primary purpose: TREATMENT

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).


Eligibility criteria: 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).

Primary outcomes:
measure: Patient Health Questionnaire-8
timeFrame: Baseline
measure: Patient Health Questionnaire-8
timeFrame: Post 8 weeks
measure: Patient Health Questionnaire-8
timeFrame: 6 month follow up
measure: Patient Health Questionnaire-8
timeFrame: 12 month follow up
measure: Generalized Anxiety Disorder-7
timeFrame: Baseline
measure: Generalized Anxiety Disorder-7
timeFrame: Post 8 weeks
measure: Generalized Anxiety Disorder-7
timeFrame: 6 month follow up
measure: Generalized Anxiety Disorder-7
timeFrame: 12 month follow up
Secondary outcomes:
measure: App Engagement From App Sessions
timeFrame: Frequency of unique app sessions from Baseline through 8 weeks
measure: App Engagement From App Session Duration
timeFrame: Duration in seconds of app sessions from Baseline through 8 weeks
measure: App Engagement From App Downloads
timeFrame: Number of apps downloaded from Baseline through 8 weeks
measure: 36-Item Short Form Survey
timeFrame: Baseline
measure: 36-Item Short Form Survey
timeFrame: 8 weeks
measure: 36-Item Short Form Survey
timeFrame: 6 months
measure: 36-Item Short Form Survey
timeFrame: 12 months
measure: Multidimensional Fatigue Symptom Inventory-Short Form
timeFrame: Baseline
measure: Multidimensional Fatigue Symptom Inventory-Short Form
timeFrame: 8 weeks
measure: Multidimensional Fatigue Symptom Inventory-Short Form
timeFrame: 6 months
measure: Multidimensional Fatigue Symptom Inventory-Short Form
timeFrame: 12 months
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index
timeFrame: 8 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 6 months
measure: Pittsburgh Sleep Quality Index
timeFrame: 12 months
measure: Alcohol Use Disorders Identification Test
timeFrame: Baseline
measure: Alcohol Use Disorders Identification Test
timeFrame: 8 weeks
measure: Alcohol Use Disorders Identification Test
timeFrame: 6 months
measure: Alcohol Use Disorders Identification Test
timeFrame: 12 months
measure: PROMIS Global Health v1.2
timeFrame: Baseline
measure: PROMIS Global Health v1.2
timeFrame: 8 weeks
measure: PROMIS Global Health v1.2
timeFrame: 6 months
measure: PROMIS Global Health v1.2
timeFrame: 12 months
measure: PROMIS Satisfaction With Sex Life
timeFrame: Baseline
measure: PROMIS Satisfaction With Sex Life
timeFrame: 8 weeks
measure: PROMIS Satisfaction With Sex Life
timeFrame: 6 months
measure: PROMIS Satisfaction With Sex Life
timeFrame: 12 months
measure: UAMS Health Literacy Measure
timeFrame: Baseline
measure: UAMS Health Literacy Measure
timeFrame: 8 weeks
measure: UAMS Health Literacy Measure
timeFrame: 6 months
measure: UAMS Health Literacy Measure
timeFrame: 12 months
measure: Penn State Worry Questionnaire
timeFrame: Baseline
measure: Penn State Worry Questionnaire
timeFrame: 8 weeks
measure: Penn State Worry Questionnaire
timeFrame: 6 months
measure: Penn State Worry Questionnaire
timeFrame: 12 months
measure: Ten Item Personality Inventory
timeFrame: Baseline
measure: Ten Item Personality Inventory
timeFrame: 8 weeks
measure: Ten Item Personality Inventory
timeFrame: 6 months
measure: Ten Item Personality Inventory
timeFrame: 12 months
measure: TWente Engagement With Ehealth Technologies Scale (TWEETS)
timeFrame: Baseline
measure: TWente Engagement With Ehealth Technologies Scale (TWEETS)
timeFrame: 8 weeks
measure: TWente Engagement With Ehealth Technologies Scale (TWEETS)
timeFrame: 6 months
measure: TWente Engagement With Ehealth Technologies Scale (TWEETS)
timeFrame: 12 months
Other outcomes:
measure: Digital Intervention Evaluation Questionnaire
timeFrame: 8 weeks
measure: Digital Intervention Adherence Questionnaire
timeFrame: 8 weeks
measure: Limited List of Questions for Exit Interview
timeFrame: 8 weeks
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: