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

NCT03488745 | Unknown

• 1 other identifier: 20403
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Wellness 1; Depression; Anxiety

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (9)

• Physical Function

  Change in physical function from baseline to post-intervention (7 weeks after baseline)

• Life Meaning/purpose

  Change in life meaning/purpose from baseline to post-intervention (7 weeks after baseline)

• Sleep Quality

  Change in sleep disturbance from baseline to post-intervention (7 weeks after baseline)

• Fatigue

  Change in fatigue from baseline to post-intervention (7 weeks after baseline)

• Pain Interference

  Change in Pain Interference from baseline to post-intervention (7 weeks after baseline)

Other Outcomes (9)

• Positive and Negative Mood

  Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7

• Drug Use

  Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7

• Pain

  Surveys administered during the following weeks: 1, 2, 3, 4, 5, 6, 7

Study Arms (1)

IntelliCare + Phone Coaching

EXPERIMENTAL

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

Interventions

IntelliCare + Phone Coaching BEHAVIORAL

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.

IntelliCare + Phone Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Under 18 years old
• Non-English Speaker

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22904, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 31344674 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Philip Chow, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip Chow, PhD

CONTACT

434-924-5401; pic2u@virignia.edu

Sarah Adams, BA

CONTACT

434-243-4239; SA4FA@hscmail.mcc.virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 5, 2018
• Study Start: March 27, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: April 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)