A cancer diagnosis affects not only patients but also their caregivers. The purpose of this study is to test the feasibility of using a mobile app suite, IntelliCare, to improve the mental health of cancer patients and caregivers.
Cancer patients and/or their caregivers will receive access to the mobile app suite, IntelliCare, as well as phone coaching that will focus on how to use the apps. IntlliCare is composed of separate apps that each target a specific aspect of mental health (e.g., reducing worry). The apps are interactive and designed for users to engage in short time bursts (e.g., less than a minute). IntelliCare was originally designed to be paired with phone coaching that focuses on how to use the apps and overcome barriers to usage.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
IntelliCare is composed of 13 separate, native apps. Each app targets a specific aspect of mental health (e.g., reducing worry, increasing social support, tracking negative thoughts). The apps are available to the public in both Android and iPhone stores. Participants will be asked to try two new IntelliCare apps every week, for 7 weeks. Phone coaching will occur at Day 0, before using any of the apps, and the third week of app usage.
University of Virginia
Charlottesville, Virginia, United States
RECRUITINGDepression Symptoms
Patient-Reported Outcomes Measurement Information System 4-Item Depression Scale (from 29-item Profile), measures depression on a continuous scale. Scores on this scale range from 4-20, with a higher score indicating greater severity of depression.
Time frame: Change in depression symptoms from baseline to post-intervention (7 weeks after baseline)
Anxiety Symptoms
Patient-Reported Outcomes Measurement Information System 4-Item Anxiety Scale (from 29-item Profile), measures anxiety on a continuous scale. Scores on this scale range from 4-20, with a higher score indicating greater severity of anxiety.
Time frame: Change in anxiety symptoms from baseline to post-intervention (7 weeks after baseline)
Clinical Mood Symptoms
Patient Health Questionnaire-4 contains measures clinical symptoms of mood and anxiety disorders. Scores on this scale range from 0-12, with a higher score indicating greater severity of mood symptoms. Unlike the Patient-Reported Outcomes Measurement Information System scales, this scale has pre-determined clinical cutoffs for mild, moderate, and severe symptoms, which will be used to classify severity of mood symptoms.
Time frame: Change in clinical mood symptoms from baseline to post-intervention (7 weeks after baseline)
Physical Function
Patient-Reported Outcomes Measurement Information System 4-Item Physical Function Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating less impairment of physical function.
Time frame: Change in physical function from baseline to post-intervention (7 weeks after baseline)
Life Meaning/purpose
Patient-Reported Outcomes Measurement Information System 4-Item Life Meaning and Purpose Scale. Scores on this scale range from 4-20, with a higher score indicating more life meaning and purpose.
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Time frame: Change in life meaning/purpose from baseline to post-intervention (7 weeks after baseline)
Sleep Quality
Patient-Reported Outcomes Measurement Information System 4-Item Sleep Disturbance Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating more sleep disturbance.
Time frame: Change in sleep disturbance from baseline to post-intervention (7 weeks after baseline)
Fatigue
Patient-Reported Outcomes Measurement Information System 4-Item Fatigue Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating more fatigue.
Time frame: Change in fatigue from baseline to post-intervention (7 weeks after baseline)
Pain Interference
Patient-Reported Outcomes Measurement Information System 4-Item Fatigue Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating more pain interference in daily life.
Time frame: Change in Pain Interference from baseline to post-intervention (7 weeks after baseline)
Patient Health Care Utilization
Created a scale since none currently exist. Items (in order) are the following: 1. Over the past two months, how many times did you go to the emergency department? 2. Were any of these visits related to your side effects from cancer treatment? (Yes/No/I Don't Know) 3. How many visits were related to side effects from cancer treatment? 4. Over the past two months, did you ever miss a scheduled appointment for cancer treatment? (Yes/No/I Don't Know) 5. How many appointments did you miss? 6. Over the past two months, have you used any cancer support services? These include programs for emotional support, or services for transportation, lodging, or other needs related to cancer treatment. (Yes/No/I Don't Know) 7. What types of services have you used?
Time frame: Change in Patient Health Care Utilization from baseline to post-intervention (7 weeks after baseline)
Caregiver Health Care Utilization
Created a scale since none currently exist. Items (in order) are the following: 1. Over the past two months, how many times did you go to the emergency department? 2. Over the past two months, how many times did you visit your primary care doctor for anything OTHER THAN routine care? 3. Over the past two months, have you used any cancer support services? These include programs for emotional support, or services for transportation, lodging, or other needs related to caregiving for your loved one with cancer. (Yes/No/I Don't Know) 4. What types of services have you used?
Time frame: Change in Caregiver Health Care Utilization from baseline to post-intervention (7 weeks after baseline)
Ability to Participate in Social Roles and Activities
Patient-Reported Outcomes Measurement Information System 4-Item Ability to Participate in Social Roles and Activities Scale (from 29-item Profile). Scores on this scale range from 4-20, with a higher score indicating more ability to participate in social roles and activities in daily life.
Time frame: Change in Ability to Participate in Social Roles and Activities from baseline to post-intervention (7 weeks after baseline)
Caregiver Self-Efficacy
Caregiver Self-Efficacy Scale (CaSES; Ugalde, Krishnasamy, \& Schofield, 2013). A 21-item scale developed to measure self-efficacy in informal cancer caregivers. Scores range from 0-84, with a higher score indicating more self-efficacy.
Time frame: Change in Caregiver Self-Efficacy from baseline to post-intervention (7 weeks after baseline)