University of Virginia
Charlottesville, Virginia, 22904, United States
NCT Number: NCT04583891
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).
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Notify Me18 year and older
Female
Interventional
Not applicable
Charlottesville, Virginia, 22904, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: Baseline
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.
Time frame: Post 8 weeks
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.
Time frame: 6 month follow up
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.
Time frame: 12 month follow up
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.
Time frame: Baseline
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.
Time frame: Post 8 weeks
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.
Time frame: 6 month follow up
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.
Time frame: 12 month follow up
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.
Time frame: Frequency of unique app sessions from Baseline through 8 weeks
Frequency of unique app sessions from Baseline through 8 weeks based on median number of app sessions
Time frame: Duration in seconds of app sessions from Baseline through 8 weeks
Duration in seconds of app sessions from Baseline through 8 weeks
Time frame: Number of apps downloaded from Baseline through 8 weeks
Number of apps downloaded from Baseline through 8 weeks
Time frame: Baseline
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.
Time frame: 8 week
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.
Time frame: 6 months
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.
Time frame: 12 months
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.
Time frame: Baseline
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.
Time frame: 8 weeks
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.
Time frame: 6 months
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.
Time frame: 12 months
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.
Time frame: Baseline
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 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient.
Time frame: 8 weeks
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 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient.
Time frame: 6 months
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 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient.
Time frame: 12 months
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 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient.
Time frame: Baseline
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.
Time frame: 8 weeks
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.
Time frame: 6 months
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.
Time frame: 12 months
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.
Time frame: Baseline
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).
Time frame: 8 weeks
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).
Time frame: 6 months
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).
Time frame: 12 months
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).
Time frame: Baseline
The PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome.
Time frame: 8 weeks
The PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome.
Time frame: 6 months
The PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome.
Time frame: 12 months
The PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome.
Time frame: Baseline
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.
Time frame: 8 weeks
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.
Time frame: 6 months
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.
Time frame: 12 months
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.
Time frame: Baseline
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.
Time frame: 8 weeks
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.
Time frame: 6 months
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.
Time frame: 12 months
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.
Time frame: Baseline
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.
Time frame: 8 weeks
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.
Time frame: 6 months
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.
Time frame: 12 months
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.
Time frame: Baseline
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion.
Time frame: 8 weeks
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion.
Time frame: 6 months
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion.
Time frame: 12 months
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion.
Time frame: Baseline
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness.
Time frame: 8 weeks
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness.
Time frame: 6 months
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness.
Time frame: 12 months
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness.
Time frame: Baseline
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness.
Time frame: 8 weeks
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness.
Time frame: 6 months
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness.
Time frame: 12 months
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness.
Time frame: Baseline
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism.
Time frame: 8 weeks
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism.
Time frame: 6 months
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism.
Time frame: 12 months
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism.
Time frame: Baseline
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness.
Time frame: 8 weeks
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness.
Time frame: 6 months
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness.
Time frame: 12 months
The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness.
Time frame: Baseline
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.
Time frame: 8 weeks
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.
Time frame: 6 months
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.
Time frame: 12 months
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.
Time frame: 8 weeks
A 12-item questionnaire with subscales of perceived utility and perceived impact of digital interventions. Each item is rated on a 0 (not at all) to 5 (very) scale and the items are summed to compute a total score ranging from 0-60. Higher scores indicate higher perceived utility and impact of a digital intervention.
Time frame: 8 weeks
A 26 item questionnaire that assesses perceived adherence to a digital intervention due to barriers to use. Each item is scored on a 0 (not at all) to 2 (very) scale and the items are summed to compute a total score ranging from 0-52. Higher scores indicate lower perceived adherence to a digital intervention due to barriers to use.
University of Virginia
Other
Evaluating a Mobile Application to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design
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