Addressing Mental Health of Cancer Patients and Caregivers Using a Mobile App Suite
- Conditions
- DepressionMental Health Wellness 1Anxiety
- Interventions
- Behavioral: IntelliCare + Phone Coaching
- Registration Number
- NCT03488745
- Lead Sponsor
- University of Virginia
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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.
- Under 18 years old
- Non-English Speaker
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IntelliCare + Phone Coaching IntelliCare + Phone Coaching 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).
- Primary Outcome Measures
Name Time Method Clinical Mood Symptoms Change in clinical mood symptoms from baseline to post-intervention (7 weeks after baseline) 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.
Depression Symptoms Change in depression symptoms from baseline to post-intervention (7 weeks after baseline) 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.
Anxiety Symptoms Change in anxiety symptoms from baseline to post-intervention (7 weeks after baseline) 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.
- Secondary Outcome Measures
Name Time Method Physical Function Change in physical function from baseline to post-intervention (7 weeks after baseline) 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.
Sleep Quality Change in sleep disturbance from baseline to post-intervention (7 weeks after baseline) 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.
Fatigue Change in fatigue from baseline to post-intervention (7 weeks after baseline) 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.
Pain Interference Change in Pain Interference from baseline to post-intervention (7 weeks after baseline) 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.
Caregiver Self-Efficacy Change in Caregiver Self-Efficacy from baseline to post-intervention (7 weeks after baseline) 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.
Life Meaning/purpose Change in life meaning/purpose from baseline to post-intervention (7 weeks after baseline) 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.
Patient Health Care Utilization Change in Patient Health Care Utilization from baseline to post-intervention (7 weeks after baseline) 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?Ability to Participate in Social Roles and Activities Change in Ability to Participate in Social Roles and Activities from baseline to post-intervention (7 weeks after baseline) 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.
Caregiver Health Care Utilization Change in Caregiver Health Care Utilization from baseline to post-intervention (7 weeks after baseline) 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?
Trial Locations
- Locations (1)
University of Virginia
🇺🇸Charlottesville, Virginia, United States