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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03488745
• Other study ID #: 20403
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2018
• Last updated: April 3, 2018
• Start date: March 27, 2018
• Est. completion date: October 2018

Study information

• Verified date: April 2018
• Source: University of Virginia
• Contact: Philip Chow, PhD
• Phone: 434-924-5401
• Email: pic2u[@]virignia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Mental Health Wellness 1

Intervention

Behavioral:
• IntelliCare + Phone Coaching
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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Positive and Negative Mood	Overall, how have you felt over the past week? (Scale from 1=Very negative to 5=Very positive)	Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Other	Drug Use	How much have you used alcohol or tobacco to cope with negative feelings? (Scale from 1=Not at all to 5=A lot or extremely)	Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Other	Pain	How much physical pain have you experienced? (Scale from 1=Not at all to 5=A lot or extremely)	Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Other	Social Connectedness	How connected did you feel to family and friends? (Scale from 1=Not at all to 5=A lot or extremely); How much support did you receive from loved ones? (Scale from 1=Not at all to 5=A lot or extremely); How much were you able to support loved ones? (Scale from 1=Not at all to 5=A lot or extremely)	Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Other	Anhedonia	How much interest or pleasure did you have in doing things? (Scale from 1=Not at all to 5=A lot or extremely)	Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Other	Anxiety	How much did you feel nervous, anxious, or on edge? (Scale from 1=Not at all to 5=A lot or extremely)	Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Other	Physical Activity	How active were you? (Scale from 1=Not at all to 5=A lot or extremely)	Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Other	Emotion Regulation	How well have you managed negative feelings? (Scale from 1=Not at all to 5=A lot or extremely)	Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Other	Future Positive and Negative Mood	Overall, how do you expect to feel next week? (Scale from 1=Very negative to 5=Very positive)	Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)