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

Primary Purpose

Mental Health Wellness 1, Depression, Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IntelliCare + Phone Coaching
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mental Health Wellness 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IntelliCare + Phone Coaching

Arm Description

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).

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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?
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?
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.
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.

Full Information

First Posted
March 20, 2018
Last Updated
April 3, 2018
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT03488745
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Wellness 1, Depression, Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IntelliCare + Phone Coaching
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
IntelliCare + Phone Coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression Symptoms
Description
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.
Time Frame
Change in depression symptoms from baseline to post-intervention (7 weeks after baseline)
Title
Anxiety Symptoms
Description
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.
Time Frame
Change in anxiety symptoms from baseline to post-intervention (7 weeks after baseline)
Title
Clinical Mood Symptoms
Description
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.
Time Frame
Change in clinical mood symptoms from baseline to post-intervention (7 weeks after baseline)
Secondary Outcome Measure Information:
Title
Physical Function
Description
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.
Time Frame
Change in physical function from baseline to post-intervention (7 weeks after baseline)
Title
Life Meaning/purpose
Description
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.
Time Frame
Change in life meaning/purpose from baseline to post-intervention (7 weeks after baseline)
Title
Sleep Quality
Description
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.
Time Frame
Change in sleep disturbance from baseline to post-intervention (7 weeks after baseline)
Title
Fatigue
Description
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.
Time Frame
Change in fatigue from baseline to post-intervention (7 weeks after baseline)
Title
Pain Interference
Description
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.
Time Frame
Change in Pain Interference from baseline to post-intervention (7 weeks after baseline)
Title
Patient Health Care Utilization
Description
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?
Time Frame
Change in Patient Health Care Utilization from baseline to post-intervention (7 weeks after baseline)
Title
Caregiver Health Care Utilization
Description
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?
Time Frame
Change in Caregiver Health Care Utilization from baseline to post-intervention (7 weeks after baseline)
Title
Ability to Participate in Social Roles and Activities
Description
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.
Time Frame
Change in Ability to Participate in Social Roles and Activities from baseline to post-intervention (7 weeks after baseline)
Title
Caregiver Self-Efficacy
Description
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.
Time Frame
Change in Caregiver Self-Efficacy from baseline to post-intervention (7 weeks after baseline)
Other Pre-specified Outcome Measures:
Title
Positive and Negative Mood
Description
Overall, how have you felt over the past week? (Scale from 1=Very negative to 5=Very positive)
Time Frame
Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Title
Drug Use
Description
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)
Time Frame
Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Title
Pain
Description
How much physical pain have you experienced? (Scale from 1=Not at all to 5=A lot or extremely)
Time Frame
Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Title
Social Connectedness
Description
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)
Time Frame
Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Title
Anhedonia
Description
How much interest or pleasure did you have in doing things? (Scale from 1=Not at all to 5=A lot or extremely)
Time Frame
Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Title
Anxiety
Description
How much did you feel nervous, anxious, or on edge? (Scale from 1=Not at all to 5=A lot or extremely)
Time Frame
Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Title
Physical Activity
Description
How active were you? (Scale from 1=Not at all to 5=A lot or extremely)
Time Frame
Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Title
Emotion Regulation
Description
How well have you managed negative feelings? (Scale from 1=Not at all to 5=A lot or extremely)
Time Frame
Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
Title
Future Positive and Negative Mood
Description
Overall, how do you expect to feel next week? (Scale from 1=Very negative to 5=Very positive)
Time Frame
Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Chow, PhD
Phone
434-924-5401
Email
pic2u@virignia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Adams, BA
Phone
434-243-4239
Email
SA4FA@hscmail.mcc.virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Chow, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Chow, PhD
Phone
434-924-5401
Email
pic2u@virginia.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31344674
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.
Results Reference
derived

Learn more about this trial

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

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