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

Study Overview
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Brief Summary
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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).

Official Title
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Evaluating a Mobile Application to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design

Conditions
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Depression, Anxiety, Engagement, Patient

Intervention / Treatment
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* Behavioral: IntelliCare
* Behavioral: Psychoeducation
* Behavioral: Coaching


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Sequential, Multiple Assignment, Randomized Trial (SMART)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IntelliCare<br>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<br>* 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.<br>Behavioral: Coaching<br>* 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.<br>|
| Active Comparator: Patient Education<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 
| Patient Health Questionnaire-8 | 9 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 months | 
| 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 months | 
| 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. | 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 months | 
| 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 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| App Engagement from App Sessions | Number of app sessions | Frequency of unique app sessions from Baseline through 8 weeks | 
| App Engagement from App Session Duration | App session duration | Duration in seconds of app sessions from Baseline through 8 weeks | 
| App Engagement from App Downloads | App downloads | Number of apps downloaded from Baseline through 8 weeks | 
| 36-Item Short Form Survey | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | Baseline | 
| 36-Item Short Form Survey | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | 8 weeks | 
| 36-Item Short Form Survey | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | 6 months | 
| 36-Item Short Form Survey | The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status. | 12 months | 
| Multidimensional Fatigue Symptom Inventory-Short Form | Fatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from -24 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient. | Baseline | 
| Multidimensional Fatigue Symptom Inventory-Short Form | Fatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from -24 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient. | 8 weeks | 
| Multidimensional Fatigue Symptom Inventory-Short Form | Fatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from -24 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient. | 6 months | 
| Multidimensional Fatigue Symptom Inventory-Short Form | Fatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from -24 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient. | 12 months | 
| Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality. | Baseline | 
| Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality. | 8 weeks | 
| Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality. | 6 months | 
| Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality. | 12 months | 
| Alcohol Use Disorders Identification Test | The Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder). | Baseline | 
| Alcohol Use Disorders Identification Test | The Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder). | 8 weeks | 
| Alcohol Use Disorders Identification Test | The Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder). | 6 months | 
| Alcohol Use Disorders Identification Test | The Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder). | 12 months | 
| PROMIS Global Health v1.2 | The PROMIS Global Health scale v1.2 contains 7 items that measure physical and mental health. Each question is scored on a 1-5 scale with a total score range of 7-35. Higher scores indicate better overall health. | Baseline | 
| PROMIS Global Health v1.2 | The PROMIS Global Health scale v1.2 contains 7 items that measure physical and mental health. Each question is scored on a 1-5 scale with a total score range of 7-35. Higher scores indicate better overall health. | 8 weeks | 
| PROMIS Global Health v1.2 | The PROMIS Global Health scale v1.2 contains 7 items that measure physical and mental health. Each question is scored on a 1-5 scale with a total score range of 7-35. Higher scores indicate better overall health. | 6 months | 
| PROMIS Global Health v1.2 | The PROMIS Global Health scale v1.2 contains 7 items that measure physical and mental health. Each question is scored on a 1-5 scale with a total score range of 7-35. Higher scores indicate better overall health. | 12 months | 
| PROMIS Satisfaction with Sex Life | The PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life. | Baseline | 
| PROMIS Satisfaction with Sex Life | The PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life. | 8 weeks | 
| PROMIS Satisfaction with Sex Life | The PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life. | 6 months | 
| PROMIS Satisfaction with Sex Life | The PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life. | 12 months | 
| UAMS Health Literacy Measure | The UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy. | Baseline | 
| UAMS Health Literacy Measure | The UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy. | 8 weeks | 
| UAMS Health Literacy Measure | The UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy. | 6 months | 
| UAMS Health Literacy Measure | The UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy. | 12 months | 
| Penn State Worry Questionnaire | The Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry. | Baseline | 
| Penn State Worry Questionnaire | The Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry. | 8 weeks | 
| Penn State Worry Questionnaire | The Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry. | 6 months | 
| Penn State Worry Questionnaire | The Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry. | 12 months | 
| Ten Item Personality Inventory | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Each personality domain is assessed by 2 items. Each item is scored on a 1-7 scale. Higher scores on each personality trait domain indicates higher levels of that personality trait. | Baseline | 
| Ten Item Personality Inventory | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Each personality domain is assessed by 2 items. Each item is scored on a 1-7 scale. Higher scores on each personality trait domain indicates higher levels of that personality trait. | 8 weeks | 
| Ten Item Personality Inventory | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Each personality domain is assessed by 2 items. Each item is scored on a 1-7 scale. Higher scores on each personality trait domain indicates higher levels of that personality trait. | 6 months | 
| Ten Item Personality Inventory | The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Each personality domain is assessed by 2 items. Each item is scored on a 1-7 scale. Higher scores on each personality trait domain indicates higher levels of that personality trait. | 12 months | 
| TWente Engagement with Ehealth Technologies Scale (TWEETS) | The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains. | Baseline | 
| TWente Engagement with Ehealth Technologies Scale (TWEETS) | The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains. | 8 weeks | 
| TWente Engagement with Ehealth Technologies Scale (TWEETS) | The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains. | 6 months | 
| TWente Engagement with Ehealth Technologies Scale (TWEETS) | The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer