ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 224 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03488745
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Philip Chow, Ph.D., 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.

Condition or disease Intervention/treatment Phase
Mental Health Wellness 1 Depression Anxiety Behavioral: IntelliCare + Phone Coaching Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Examining an App-based Mental Health Intervention for Cancer Patients and Caregivers
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Physical Function [ Time Frame: 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.

  2. Life Meaning/purpose [ Time Frame: 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.

  3. Sleep Quality [ Time Frame: 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.

  4. Fatigue [ Time Frame: 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.

  5. Pain Interference [ Time Frame: 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.

  6. Patient Health Care Utilization [ Time Frame: 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?

  7. Caregiver Health Care Utilization [ Time Frame: 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?

  8. Ability to Participate in Social Roles and Activities [ Time Frame: 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.

  9. Caregiver Self-Efficacy [ Time Frame: 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.


Other Outcome Measures:
  1. Positive and Negative Mood [ Time Frame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7 ]
    Overall, how have you felt over the past week? (Scale from 1=Very negative to 5=Very positive)

  2. Drug Use [ Time Frame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7 ]
    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)

  3. Pain [ Time Frame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7 ]
    How much physical pain have you experienced? (Scale from 1=Not at all to 5=A lot or extremely)

  4. Social Connectedness [ Time Frame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7 ]
    1. How connected did you feel to family and friends? (Scale from 1=Not at all to 5=A lot or extremely)
    2. How much support did you receive from loved ones? (Scale from 1=Not at all to 5=A lot or extremely)
    3. How much were you able to support loved ones? (Scale from 1=Not at all to 5=A lot or extremely)

  5. Anhedonia [ Time Frame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7 ]
    How much interest or pleasure did you have in doing things? (Scale from 1=Not at all to 5=A lot or extremely)

  6. Anxiety [ Time Frame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7 ]
    How much did you feel nervous, anxious, or on edge? (Scale from 1=Not at all to 5=A lot or extremely)

  7. Physical Activity [ Time Frame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7 ]
    How active were you? (Scale from 1=Not at all to 5=A lot or extremely)

  8. Emotion Regulation [ Time Frame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7 ]
    How well have you managed negative feelings? (Scale from 1=Not at all to 5=A lot or extremely)

  9. Future Positive and Negative Mood [ Time Frame: Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7 ]
    Overall, how do you expect to feel next week? (Scale from 1=Very negative to 5=Very positive)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488745


Contacts
Contact: Philip Chow, PhD 434-924-5401 pic2u@virignia.edu
Contact: Sarah Adams, BA 434-243-4239 SA4FA@hscmail.mcc.virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22904
Contact: Philip Chow, PhD    434-924-5401    pic2u@virginia.edu   
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Philip Chow, PhD University of Virginia

Responsible Party: Philip Chow, Ph.D., Assistant Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT03488745     History of Changes
Other Study ID Numbers: 20403
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No