Clinical trial NCT04515810: Mobile Health Application (PACT) to Improve Engagement in Advance Care Planning
Official title: Planning Advance Care Together (PACT) to Improve Engagement in Advance Care Planning
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Solid Neoplasm
Keywords: Advance Care Planning
Advance Directives
End-of-Life
Cancer
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-08-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This clinical trial tests a new mobile health application (app) called Planning Advance Care Together (PACT) to help people with cancer talk about and plan for advance care planning (the care they would want if they were unable to communicate) with their loved ones and doctors. The development of the PACT mobile app may help future patients incorporate their social network (typically, but not exclusively, family) into the advance care planning process.

Detailed description: OUTLINE: Patients and support persons are randomized to 1 of 2 arms.

ARM I: Participants use PACT mHealth app.

ARM II: Participants engage in standard care with no modifications.

After completion of study intervention, participants are followed up at 3 and 6 months.

Eligibility criteria: Inclusion Criteria:

* PATIENT: Diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic cancer and/or disease progression following at least first line systemic therapy.
* PATIENT: Access to a mobile device; the principal investigator (PI) will ensure that those who have access to a mobile device have access to a mobile device with internet access to ensure they can complete study procedures.
* PATIENT: The ability to provide informed consent.
* PATIENT: Identification and enrollment of a loved support person.
* PATIENT: 18 years of age or older.
* SUPPORT PERSON: The person (family member or friend) whom the patient indicates being a support person.
* SUPPORT PERSON: English speaking.
* SUPPORT PERSON: 18 years of age or older and able to provide informed consent.
* PROVIDER: Current clinical practice and/or research with advanced cancer patients.
* PROVIDER: A history of 3+ years working with advanced cancer patients.
* PROVIDER: 18 years of age or older. Providers across disciplines (e.g., social work, oncology) will be enrolled.

Exclusion Criteria:

* PATIENT: Not fluent in English.
* PATIENT: Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of \>= 6) to be delivered by trained study research staff during screening.
* PATIENT: Too ill or weak to complete the interviews (as judged by the interviewer).
* PATIENT: Currently receiving hospice at the time of enrollment.
* PATIENT: Children and young adults under age 18.
* PATIENT: Resides outside of the United States.
* SUPPORT PERSON AND PROVIDERS: Resides outside of the United States.

Primary outcomes:
measure: Feasibility: Accrual rates [Patients]
timeFrame: At 3 months post-randomization
measure: Feasibility: Accrual rates [Support persons]
timeFrame: At 3 months post-randomization
measure: Feasibility: Rates of intervention completion [Patients]
timeFrame: At 3 months post-randomization
measure: Feasibility: Rates of intervention completion [Support persons]
timeFrame: At 3 months post-randomization
measure: Acceptability of the PACT application: Acceptability E-Scale [Patients]
timeFrame: At 3 months post-randomization
measure: Acceptability of the PACT application: Acceptability E-Scale [Support persons]
timeFrame: At 3 months post-randomization
measure: Usability of the PACT application: System Usability Scale (SUS) [Patients]
timeFrame: At 3 months post-randomization
measure: Usability of the PACT application: System Usability Scale (SUS) [Support persons]
timeFrame: At 3 months post-randomization
measure: User satisfaction [Patients]
timeFrame: At 3 months post-randomization
measure: User satisfaction [Support persons]
timeFrame: At 3 months post-randomization
measure: User engagement as measured by number of views [Patients]
timeFrame: Baseline to 3 months post-intervention
measure: User engagement as measured by number of views [Support persons]
timeFrame: Baseline to 3 months post-intervention
measure: User engagement as measured by time spent on app [Patients]
timeFrame: Baseline to 3 months post-intervention
measure: User engagement as measured by time spent on app [Support persons]
timeFrame: Baseline to 3 months post-intervention
measure: Change in level of engagement in advance care planning [Patients]
timeFrame: Baseline to 3 months post-intervention
measure: Change in level of engagement in advance care planning [Patients]
timeFrame: Baseline to 6 months post-intervention
measure: Change in level of engagement in advance care planning [Support persons]
timeFrame: Baseline to 3 months post-intervention
measure: Change in level of engagement in advance care planning [Support persons]
timeFrame: Baseline to 6 months post-intervention
measure: Change in documentation of advance care planning conversations [Patients]
timeFrame: Baseline to 3 months post-intervention
measure: Change in documentation of advance care planning conversations [Patients]
timeFrame: Baseline to 6 months post-intervention
measure: Change in documentation of advance care planning conversations [Support persons]
timeFrame: Baseline to 3 months post-intervention
measure: Change in documentation of advance care planning conversations [Support persons]
timeFrame: Baseline to 6 months post-intervention
measure: Change in completion of advance directives
timeFrame: Baseline to 3 months post-intervention
measure: Change in completion of advance directives
timeFrame: Baseline to 6 months post-intervention
Secondary outcomes:
measure: Change in treatment preference
timeFrame: Baseline to 3 months
measure: Change in treatment preference
timeFrame: Baseline to 6 months
measure: Change in healthcare utilization (summary score for total number of healthcare services utilized)
timeFrame: Baseline to 3 months
measure: Change in healthcare utilization (summary score for total number of healthcare services utilized)
timeFrame: Baseline to 6 months
measure: Change in number of subjects receiving goal-concordant care
timeFrame: Baseline to 3 months
measure: Change in number of subjects receiving goal-concordant care
timeFrame: Baseline to 6 months
measure: Change in perceived social support
timeFrame: Baseline to 3 months
measure: Change in perceived social support
timeFrame: Baseline to 6 months
measure: Change in family functioning
timeFrame: Baseline to 3 months
measure: Change in family functioning
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: NYP/Weill Cornell Medical Center
state: New York
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Megan J Shen, PhD
role: PRINCIPAL_INVESTIGATOR
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