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

April 3, 2018 updated by: Philip Chow, Ph.D., University of Virginia

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22904
        • Recruiting
        • University of Virginia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change in depression symptoms from baseline to post-intervention (7 weeks after baseline)
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.
Change in anxiety symptoms from baseline to post-intervention (7 weeks after baseline)
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.
Change in clinical mood symptoms from baseline to post-intervention (7 weeks after baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Change in physical function from baseline to post-intervention (7 weeks after baseline)
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.
Change in life meaning/purpose from baseline to post-intervention (7 weeks after baseline)
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.
Change in sleep disturbance from baseline to post-intervention (7 weeks after baseline)
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.
Change in fatigue from baseline to post-intervention (7 weeks after baseline)
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.
Change in Pain Interference from baseline to post-intervention (7 weeks after baseline)
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?
Change in Patient Health Care Utilization from baseline to post-intervention (7 weeks after baseline)
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?
Change in Caregiver Health Care Utilization from baseline to post-intervention (7 weeks after baseline)
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.
Change in Ability to Participate in Social Roles and Activities from baseline to post-intervention (7 weeks after baseline)
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.
Change in Caregiver Self-Efficacy from baseline to post-intervention (7 weeks after baseline)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
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)
Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
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)
Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
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)
Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
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)
Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
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)
Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 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)
Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
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)
Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7
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)
Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Virginia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Philip Chow, PhD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on IntelliCare + Phone Coaching

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings