Mental Health Wellness 1NCT03488745
Addressing Mental Health of Cancer Patients and Caregivers Using a Mobile App Suite
A study testing IntelliCare + Phone Coaching in people with Mental Health Wellness 1 and Depression, run by University of Virginia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1, Depression, Anxiety
- What is being tested?
- IntelliCare + Phone Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2018to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Under 18 years old
- Non-English Speaker
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22904
Philip Chow, PhD, 434-924-5401, pic2u@virginia.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health Wellness 1, Depression, Anxiety
- Being tested
- IntelliCare + Phone Coaching
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntelliCare + Phone CoachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: IntelliCare + Phone Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change in clinical mood symptoms from baseline to post-intervention (7 weeks after baseline)
Secondary outcomes (9)
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.
Measured: Change in physical function from baseline to post-intervention (7 weeks after baseline)
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.
Measured: Change in life meaning/purpose from baseline to post-intervention (7 weeks after baseline)
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.
Measured: Change in sleep disturbance from baseline to post-intervention (7 weeks after baseline)
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.
Measured: Change in fatigue from baseline to post-intervention (7 weeks after baseline)
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.
Measured: Change in Pain Interference from baseline to post-intervention (7 weeks after baseline)
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?
Measured: Change in Patient Health Care Utilization from baseline to post-intervention (7 weeks after baseline)
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?
Measured: Change in Caregiver Health Care Utilization from baseline to post-intervention (7 weeks after baseline)
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.
Measured: Change in Ability to Participate in Social Roles and Activities from baseline to post-intervention (7 weeks after baseline)
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.
Measured: Change in Caregiver Self-Efficacy from baseline to post-intervention (7 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start27 Mar 2018
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Chow, Ph.D., University of Virginia
- Investigators
- Philip Chow, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488745
- Sponsor's protocol ID
- 20403
- Status last verified
- Apr 2018
- First submitted
- 20 Mar 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31344674
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining an App-based Mental Health Intervention for Cancer Patients and Caregivers
- ClinicalTrials.gov ID
- NCT03488745
- Acronym / sponsor ID
- 20403
- Conditions
- Mental Health Wellness 1, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IntelliCare + Phone Coaching | Experimental | Behavioral: IntelliCare + Phone CoachingParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Under 18 years old
- Non-English Speaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IntelliCare + Phone CoachingIntelliCare 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. | Behavioural | IntelliCare + Phone Coaching |
Primary outcome
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.
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.
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.
9 secondary outcomes
Physical Function
Time frame: 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)
Sleep Quality
Time frame: 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)
Pain Interference
Time frame: 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)
Caregiver Health Care Utilization
Time frame: 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)
Caregiver Self-Efficacy
Time frame: Change in Caregiver Self-Efficacy from baseline to post-intervention (7 weeks after baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Derived from this study: PubMed 31344674Chow 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Chow, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IntelliCare + Phone Coaching in people with Mental Health Wellness 1 and Depression, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip Chow, PhD (434-924-5401, pic2u@virignia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Symptoms (time frame: Change in depression symptoms from baseline to post-intervention (7 weeks after baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03488745, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.