Mobile Health Application (PACT) to Improve Engagement in Advance Care Planning

NCT04515810 | Recruiting

• 4 other identifiers: RG1121852R37CA246703NCI-2022-0039810849
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 4

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.

Conditions

Malignant Solid Neoplasm

Keywords

Advance Care Planning; Advance Directives; End-of-Life; Cancer

Outcome Measures

Primary Outcomes (24)

• Feasibility: Accrual rates [Patients]

  Will assess the percentage of eligible approached patients who consent to enroll in the study

  At 3 months post-randomization

• Feasibility: Accrual rates [Support persons]

  Will assess the percentage of eligible approached support persons who consent to enroll in the study

  At 3 months post-randomization

• Feasibility: Rates of intervention completion [Patients]

  Will assess the percentage of enrolled patients who complete the intervention

  At 3 months post-randomization

• Feasibility: Rates of intervention completion [Support persons]

  Will assess the percentage of enrolled support persons who complete the intervention

  At 3 months post-randomization

• Acceptability of the PACT application: Acceptability E-Scale [Patients]

  The Acceptability E-Scale is a 6-item scale, scored on a 5-point Likert scale (e.g., 1=very difficult; 5= very easy), with previously demonstrated good internal consistency (Cronbach's alpha=.76), with higher values indicating higher levels of acceptability.

  At 3 months post-randomization

• Acceptability of the PACT application: Acceptability E-Scale [Support persons]

  The Acceptability E-Scale is a 6-item scale, scored on a 5-point Likert scale (e.g., 1=very difficult; 5= very easy), with previously demonstrated good internal consistency (Cronbach's alpha=.76), with higher values indicating higher levels of acceptability.

  At 3 months post-randomization

• Usability of the PACT application: System Usability Scale (SUS) [Patients]

  Usability of the PACT application will be assessed among patients using the System Usability Scale (SUS). The SUS is a 10-item scale, scored on a 5-point Lilkert scale (1=strongly disagree; 5=strongly agree), with higher values indicating higher levels of usability

  At 3 months post-randomization

• Usability of the PACT application: System Usability Scale (SUS) [Support persons]

  Usability of the PACT application will be assessed among support persons using the System Usability Scale (SUS). The SUS is a 10-item scale, scored on a 5-point Lilkert scale (1=strongly disagree; 5=strongly agree), with higher values indicating higher levels of usability

  At 3 months post-randomization

• User satisfaction [Patients]

  User satisfaction: Patients will engage in an exit interview that assesses their overall satisfaction with the app on a Likert scale ranging from 1-10 (1=not at all satisfied; 10 = extremely satisfied), with higher values indicating higher levels of satisfaction

  At 3 months post-randomization

• User satisfaction [Support persons]

  User satisfaction: Support persons will engage in an exit interview that assesses their overall satisfaction with the app on a Likert scale ranging from 1-10 (1=not at all satisfied; 10 = extremely satisfied), with higher values indicating higher levels of satisfaction

  At 3 months post-randomization

• User engagement as measured by number of views [Patients]

  User engagement will be assessed through tracking of activity (i.e., number of views) over a 3-month period following randomization.

  Baseline to 3 months post-intervention

• User engagement as measured by number of views [Support persons]

  User engagement will be assessed through tracking of activity (i.e., number of views) over a 3-month period following randomization.

  Baseline to 3 months post-intervention

• User engagement as measured by time spent on app [Patients]

  User engagement will be assessed through tracking of activity (i.e., time spent on app) over a 3-month period following randomization.

  Baseline to 3 months post-intervention

• User engagement as measured by time spent on app [Support persons]

  User engagement will be assessed through tracking of activity (i.e., time spent on app) over a 3-month period following randomization.

  Baseline to 3 months post-intervention

• Change in level of engagement in advance care planning [Patients]

  Patients will be assessed using the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).

  Baseline to 3 months post-intervention

• Change in level of engagement in advance care planning [Patients]

  Patients will be assessed using the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).

  Baseline to 6 months post-intervention

• Change in level of engagement in advance care planning [Support persons]

  Support persons will be assessed using an adapted support person version of the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).

  Baseline to 3 months post-intervention

• Change in level of engagement in advance care planning [Support persons]

  Support persons will be assessed using an adapted support person version of the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).

  Baseline to 6 months post-intervention

• Change in documentation of advance care planning conversations [Patients]

  This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family and doctor (all yes/no questions).

  Baseline to 3 months post-intervention

• Change in documentation of advance care planning conversations [Patients]

  This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family and doctor (all yes/no questions).

  Baseline to 6 months post-intervention

• Change in documentation of advance care planning conversations [Support persons]

  This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with patient and patient's doctor) (all yes/no questions).

  Baseline to 3 months post-intervention

• Change in documentation of advance care planning conversations [Support persons]

  This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with patient and patient's doctor) (all yes/no questions).

  Baseline to 6 months post-intervention

• Change in completion of advance directives

  This will be assessed by asking patients whether they have completed a Do Not Resuscitate order (DNR), living will, or identified a Health Care Proxy (HCP). All yes/no questions.

  Baseline to 3 months post-intervention

• Change in completion of advance directives

  This will be assessed by asking patients whether they have completed a Do Not Resuscitate order (DNR), living will, or identified a Health Care Proxy (HCP). All yes/no questions.

  Baseline to 6 months post-intervention

Secondary Outcomes (10)

• Change in treatment preference

  Baseline to 3 months

• Change in treatment preference

  Baseline to 6 months

• Change in healthcare utilization (summary score for total number of healthcare services utilized)

  Baseline to 3 months

• Change in healthcare utilization (summary score for total number of healthcare services utilized)

  Baseline to 6 months

• Change in number of subjects receiving goal-concordant care

  Baseline to 3 months

Study Arms (2)

Arm I (PACT)

EXPERIMENTAL

Participants use PACT mHealth app.

Other: Internet-Based Intervention; Other: Questionnaire Administration

Arm II (standard care)

ACTIVE COMPARATOR

Participants engage in standard care with no modifications.

Other: Best Practice; Other: Questionnaire Administration

Interventions

Internet-Based Intervention OTHER

Use smartphone application

Arm I (PACT)

Best Practice OTHER

Engage in standard care

Also known as: standard of care, standard therapy

Arm II (standard care)

Questionnaire Administration OTHER

Ancillary studies

Arm I (PACT); Arm II (standard care)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Northwell Health

Manhasset, New York, 11030, United States

NOT YET RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

ACTIVE NOT RECRUITING

NYP/Weill Cornell Medical Center

New York, New York, 10065, United States

NOT YET RECRUITING

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

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Related Links

• Usability.gov. System Usability Scale (SUS)
• Measuring Usability with the System Usability Scale

MeSH Terms

Conditions

Death; Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Megan J Shen, PhD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia De Los Santos, B.S.

CONTACT

206-667-1565; cdelossa@fredhutch.org

Megan Shen, PhD

CONTACT

206-667-4172; mshen2@fredhutch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 17, 2020
• Study Start: February 18, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)