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

Fred Hutchinson Cancer Center (FHCC)

Status: Enrolling

Conditions: Malignant Solid Neoplasm

Treatments: Other: Questionnaire Administration; Other: Internet-Based Intervention; Other: Best Practice

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04515810

10849

NCI-2022-00398 (Registry Identifier)

R37CA246703 (U.S. NIH Grant/Contract)

RG1121852

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups

Arm I (PACT)

Experimental group

Description:

Participants use PACT mHealth app.

Treatment:

Other: Internet-Based Intervention

Other: Questionnaire Administration

Arm II (standard care)

Active Comparator group

Description:

Participants engage in standard care with no modifications.

Treatment:

Other: Best Practice

Other: Questionnaire Administration