Addressing Mental Health of Cancer Patients and Caregivers Using a Mobile App Suite

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Examining an App-based Mental Health Intervention for Cancer Patients and Caregivers

Conditions
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Mental Health Wellness 1, Depression, Anxiety

Intervention / Treatment
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* Behavioral: IntelliCare + Phone Coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willingness and ability to comply with scheduled visits and study procedures. Caregiver/support person of patient undergoing treatment for cancer in the Breast Care Clinic OR patient undergoing treatment for cancer in the Breast Care Clinic Owns a smart phone or they are willing to carry one during the study if one is provided. Exclusion Criteria: Under 18 years old Non-English Speaker

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IntelliCare + Phone Coaching<br>Participants will receive IntelliCare apps with phone coaching for 7 weeks. In this arm, participants will pick two IntelliCare apps to use every week. Participants will receive a phone coaching call before they use the apps, for approximately 30 minutes, as well as 3 weeks after initiating app use (10 minute call). | Behavioral: IntelliCare + Phone Coaching<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression 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. | 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. | 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. | Change in clinical mood symptoms from baseline to post-intervention (7 weeks after baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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: Over the past two months, how many times did you go to the emergency department? Were any of these visits related to your side effects from cancer treatment? (Yes/No/I Don't Know) How many visits were related to side effects from cancer treatment? Over the past two months, did you ever miss a scheduled appointment for cancer treatment? (Yes/No/I Don't Know) How many appointments did you miss? 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) What types of services have you used? | 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: Over the past two months, how many times did you go to the emergency department? Over the past two months, how many times did you visit your primary care doctor for anything OTHER THAN routine care? 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) What types of services have you used? | 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. | 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. | Change in Caregiver Self-Efficacy from baseline to post-intervention (7 weeks after baseline) |