Clinical trial NCT03488745: Addressing Mental Health of Cancer Patients and Caregivers Using a Mobile App Suite
Official title: Examining an App-based Mental Health Intervention for Cancer Patients and Caregivers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Wellness 1
Depression
Anxiety
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depression Symptoms
timeFrame: Change in depression symptoms from baseline to post-intervention (7 weeks after baseline)
measure: Anxiety Symptoms
timeFrame: Change in anxiety symptoms from baseline to post-intervention (7 weeks after baseline)
measure: Clinical Mood Symptoms
timeFrame: Change in clinical mood symptoms from baseline to post-intervention (7 weeks after baseline)
Secondary outcomes:
measure: Physical Function
timeFrame: Change in physical function from baseline to post-intervention (7 weeks after baseline)
measure: Life Meaning/purpose
timeFrame: Change in life meaning/purpose from baseline to post-intervention (7 weeks after baseline)
measure: Sleep Quality
timeFrame: Change in sleep disturbance from baseline to post-intervention (7 weeks after baseline)
measure: Fatigue
timeFrame: Change in fatigue from baseline to post-intervention (7 weeks after baseline)
measure: Pain Interference
timeFrame: Change in Pain Interference from baseline to post-intervention (7 weeks after baseline)
measure: Patient Health Care Utilization
timeFrame: Change in Patient Health Care Utilization from baseline to post-intervention (7 weeks after baseline)
measure: Caregiver Health Care Utilization
timeFrame: Change in Caregiver Health Care Utilization from baseline to post-intervention (7 weeks after baseline)
measure: Ability to Participate in Social Roles and Activities
timeFrame: Change in Ability to Participate in Social Roles and Activities from baseline to post-intervention (7 weeks after baseline)
measure: Caregiver Self-Efficacy
timeFrame: Change in Caregiver Self-Efficacy from baseline to post-intervention (7 weeks after baseline)
Other outcomes:
measure: Positive and Negative Mood
timeFrame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
measure: Drug Use
timeFrame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
measure: Pain
timeFrame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
measure: Social Connectedness
timeFrame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
measure: Anhedonia
timeFrame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
measure: Anxiety
timeFrame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
measure: Physical Activity
timeFrame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
measure: Emotion Regulation
timeFrame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
measure: Future Positive and Negative Mood
timeFrame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Philip Chow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chow PI, Showalter SL, Gerber MS, Kennedy E, Brenin DR, Schroen AT, Mohr DC, Lattie EG, Cohn WF. Use of Mental Health Apps by Breast Cancer Patients and Their Caregivers in the United States: Protocol for a Pilot Pre-Post Study. JMIR Res Protoc. 2019 Jan 14;8(1):e11452. doi: 10.2196/11452.