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Completed

NCT Number: NCT04583891

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

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22904, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

IntelliCare

Behavioral

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

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Patient Health Questionnaire-8

    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.

  2. Patient Health Questionnaire-8

    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.

  3. Patient Health Questionnaire-8

    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.

  4. Patient Health Questionnaire-8

    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.

  5. Generalized Anxiety Disorder-7

    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.

  6. Generalized Anxiety Disorder-7

    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.

  7. Generalized Anxiety Disorder-7

    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.

  8. Generalized Anxiety Disorder-7

    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.

Secondary outcomes

  1. App Engagement From App Sessions

    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

  2. App Engagement From App Session Duration

    Time frame: Duration in seconds of app sessions from Baseline through 8 weeks

    Duration in seconds of app sessions from Baseline through 8 weeks

  3. App Engagement From App Downloads

    Time frame: Number of apps downloaded from Baseline through 8 weeks

    Number of apps downloaded from Baseline through 8 weeks

  4. 36-Item Short Form Survey - Physical Health

    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.

  5. 36-Item Short Form Survey - Physical Health

    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.

  6. 36-Item Short Form Survey - Physical Health

    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.

  7. 36-Item Short Form Survey - Physical Health

    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.

  8. 36-Item Short Form Survey - Mental Health

    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.

  9. 36-Item Short Form Survey - Mental Health

    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.

  10. 36-Item Short Form Survey - Mental Health

    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.

  11. 36-Item Short Form Survey - Mental Health

    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.

  12. Multidimensional Fatigue Symptom Inventory-Short Form

    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.

  13. Multidimensional Fatigue Symptom Inventory-Short Form

    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.

  14. Multidimensional Fatigue Symptom Inventory-Short Form

    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.

  15. Multidimensional Fatigue Symptom Inventory-Short Form

    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.

  16. Pittsburgh Sleep Quality Index

    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.

  17. Pittsburgh Sleep Quality Index

    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.

  18. Pittsburgh Sleep Quality Index

    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.

  19. Pittsburgh Sleep Quality Index

    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.

  20. Alcohol Use Disorders Identification Test

    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).

  21. Alcohol Use Disorders Identification Test

    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).

  22. Alcohol Use Disorders Identification Test

    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).

  23. Alcohol Use Disorders Identification Test

    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).

  24. PROMIS Global Mental Health v1.2

    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.

  25. PROMIS Global Mental Health v1.2

    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.

  26. PROMIS Global Mental Health v1.2

    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.

  27. PROMIS Global Mental Health v1.2

    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.

  28. PROMIS Satisfaction With Sex Life

    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.

  29. PROMIS Satisfaction With 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.

  30. PROMIS Satisfaction With 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.

  31. PROMIS Satisfaction With 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.

  32. UAMS Health Literacy Measure

    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.

  33. UAMS Health Literacy Measure

    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.

  34. UAMS Health Literacy Measure

    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.

  35. UAMS Health Literacy Measure

    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.

  36. Penn State Worry Questionnaire

    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.

  37. Penn State Worry Questionnaire

    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.

  38. Penn State Worry Questionnaire

    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.

  39. Penn State Worry Questionnaire

    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.

  40. Ten Item Personality Inventory- 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). 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.

  41. Ten Item Personality Inventory - 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.

  42. Ten Item Personality Inventory - 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.

  43. Ten Item Personality Inventory - 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.

  44. Ten Item Personality Inventory - 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). 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.

  45. Ten Item Personality Inventory - 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.

  46. Ten Item Personality Inventory - 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.

  47. Ten Item Personality Inventory - 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.

  48. Ten Item Personality Inventory - 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). 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.

  49. Ten Item Personality Inventory - 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.

  50. Ten Item Personality Inventory - 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.

  51. Ten Item Personality Inventory - 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.

  52. Ten Item Personality Inventory - 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). 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.

  53. Ten Item Personality Inventory - 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.

  54. Ten Item Personality Inventory - 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.

  55. Ten Item Personality Inventory - 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.

  56. Ten Item Personality Inventory - Openness

    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.

  57. Ten Item Personality Inventory - 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.

  58. Ten Item Personality Inventory - 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.

  59. Ten Item Personality Inventory - 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.

  60. TWente Engagement With Ehealth Technologies Scale (TWEETS)

    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.

  61. TWente Engagement With Ehealth Technologies Scale (TWEETS)

    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.

  62. TWente Engagement With Ehealth Technologies Scale (TWEETS)

    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.

  63. TWente Engagement With Ehealth Technologies Scale (TWEETS)

    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.

Other outcomes

  1. Digital Intervention Evaluation Questionnaire

    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.

  2. Digital Intervention Adherence Questionnaire

    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.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • National Cancer Institute (NCI)
  • Northwestern University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 12, 2020
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

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