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

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04583891
• Other study ID #: 200218
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: September 2023
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 314
• Est. completion date: November 30, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Neoplasms
• Depression, Anxiety
• Engagement, Patient

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Digital Intervention Evaluation Questionnaire	A single questionnaire with subscales of perceived utility and perceived impact; 18 items each scored on a 0 (not at all) to 5 (very) scale	8 weeks
Other	Digital Intervention Adherence Questionnaire	A single questionnaire that assesses barriers to program use; 32 items each scored on a 0 (not at all) to 2 (very) scale	8 weeks
Other	Limited List of Questions for Exit Interview	Only those that receive the IntelliCare apps will be administered a qualitative interview that contains items assessing how the app intervention met their needs as a breast cancer survivor and possible changes to improve fit. Study staff will administer this interview on the phone. 10 questions will assess overall impressions of the IntelliCare app program. Additional questions will focus on specific apps within the IntelliCare program and how they can be tailored in future studies.	8 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	App Engagement from App Sessions	Number of app sessions	Frequency of unique app sessions from Baseline through 8 weeks
Secondary	App Engagement from App Session Duration	App session duration	Duration in seconds of app sessions from Baseline through 8 weeks
Secondary	App Engagement from App Downloads	App downloads	Number of apps downloaded from Baseline through 8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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