Examining an App-based Mental Health Intervention for Cancer Patients and Caregivers
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Virginia
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Clinical Mood Symptoms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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).
Intervention: IntelliCare + Phone Coaching (Behavioral)
Outcomes
Primary Outcomes
Clinical Mood Symptoms
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Physical Function(Change in physical function from baseline to post-intervention (7 weeks after baseline))
- Sleep Quality(Change in sleep disturbance from baseline to post-intervention (7 weeks after baseline))
- Fatigue(Change in fatigue from baseline to post-intervention (7 weeks after baseline))
- Pain Interference(Change in Pain Interference from baseline to post-intervention (7 weeks after baseline))
- Caregiver Self-Efficacy(Change in Caregiver Self-Efficacy from baseline to post-intervention (7 weeks after baseline))
- Life Meaning/purpose(Change in life meaning/purpose from baseline to post-intervention (7 weeks after baseline))
- Patient Health Care Utilization(Change in Patient Health Care Utilization from baseline to post-intervention (7 weeks after baseline))
- 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))
- Caregiver Health Care Utilization(Change in Caregiver Health Care Utilization from baseline to post-intervention (7 weeks after baseline))
Investigators
Philip Chow, Ph.D.
Assistant Professor
University of Virginia