Recruiting

Mobile Health Application

Sponsor:

Fred Hutchinson Cancer Center

Code:

NCT04515810

Conditions

Locally Advanced Malignant Solid Neoplasm

Metastatic Malignant Solid Neoplasm

Recurrent Hematologic Malignancy

Refractory Hematologic Malignancy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Internet-Based Intervention

Best Practice

Telephone-Based Intervention

Questionnaire Administration

Post-intervention qualitative feedback interview

Study Details

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

Locally Advanced Malignant Solid Neoplasm

Metastatic Malignant Solid Neoplasm

Recurrent Hematologic Malignancy

Refractory Hematologic Malignancy

Study ID

NCT04515810

Start date

Feb 18, 2025

Status verified date

Aug, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • PATIENT: Diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic solid cancer and/or disease progression following at least first line systemic therapy and/or relapsed or refractory hematologic cancer.
  • PATIENT: Have internet access through a computer or a mobile device; the principal investigator (PI) will ensure that those who have access to a computer or mobile device have access to a computer or mobile device with internet access to ensure they can complete study procedures.
  • PATIENT: The ability to provide informed consent.
  • PATIENT: Identification of a loved support person if one is available; patients who are unable to identify a support person willing to participate with them will be allowed to continue in the study on their own.
  • 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.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Arm I (PACT)

Participants use PACT mHealth app for up to 4 weeks and receive one check-in call on study.

active comparator: Arm II (standard care)

Participants engage in standard care with no modifications for up to 4 weeks.

Interventions

Internet-Based Intervention

Use smartphone application

Best Practice

Engage in standard care

Telephone-Based Intervention

Receive check-in call

Questionnaire Administration

Ancillary studies

Post-intervention qualitative feedback interview

Post-intervention qualitative feedback interview (with a subset of patients and support persons)

Primary outcome measure

  • Feasibility: Accrual rates [Patients] [ Time Frame: At 3 months post-randomization ]
  • Feasibility: Accrual rates [Support persons] [ Time Frame: At 3 months post-randomization ]
  • Feasibility: Rates of intervention completion [Patients] [ Time Frame: At 3 months post-randomization ]
  • Feasibility: Rates of intervention completion [Support persons] [ Time Frame: At 3 months post-randomization ]
  • Acceptability of the PACT application: Acceptability E-Scale [Patients] [ Time Frame: At 3 months post-randomization ]
  • Acceptability of the PACT application: Acceptability E-Scale [Support persons] [ Time Frame: At 3 months post-randomization ]
  • Usability of the PACT application: System Usability Scale (SUS) [Patients] [ Time Frame: At 3 months post-randomization ]
  • Usability of the PACT application: System Usability Scale (SUS) [Support persons] [ Time Frame: At 3 months post-randomization ]
  • User satisfaction [Patients] [ Time Frame: At 3 months post-randomization ]
  • User satisfaction [Support persons] [ Time Frame: At 3 months post-randomization ]
  • User engagement as measured by number of views [Patients] [ Time Frame: Baseline to 3 months post-intervention ]
  • User engagement as measured by number of views [Support persons] [ Time Frame: Baseline to 3 months post-intervention ]
  • User engagement as measured by time spent on app [Patients] [ Time Frame: Baseline to 3 months post-intervention ]
  • User engagement as measured by time spent on app [Support persons] [ Time Frame: Baseline to 3 months post-intervention ]
  • Change in level of engagement in advance care planning [Patients] [ Time Frame: Baseline to 3 months post-intervention ]
  • Change in level of engagement in advance care planning [Patients] [ Time Frame: Baseline to 6 months post-intervention ]
  • Change in level of engagement in advance care planning [Support persons] [ Time Frame: Baseline to 3 months post-intervention ]
  • Change in level of engagement in advance care planning [Support persons] [ Time Frame: Baseline to 6 months post-intervention ]
  • Change in documentation of advance care planning conversations [Patients] [ Time Frame: Baseline to 3 months post-intervention ]
  • Change in documentation of advance care planning conversations [Patients] [ Time Frame: Baseline to 6 months post-intervention ]
  • Change in documentation of advance care planning conversations [Support persons] [ Time Frame: Baseline to 3 months post-intervention ]
  • Change in documentation of advance care planning conversations [Support persons] [ Time Frame: Baseline to 6 months post-intervention ]
  • Change in completion of advance directives [ Time Frame: Baseline to 3 months post-intervention ]
  • Change in completion of advance directives [ Time Frame: Baseline to 6 months post-intervention ]

Central Contacts and Locations

Central contacts

Claudia De Los Santos, B.S.

206-667-1565cdelossa@fredhutch.org

Megan Shen, PhD

206-667-4172mshen2@fredhutch.org

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Claudia De Los Santos, B.S.

206-667-1565cdelossa@fredhutch.org

Megan J Shen, PhD

206-667-4172mshen2@fredhutch.org

Principal Investigator:

Megan J Shen, PhD

More Information

Sponsor

Fred Hutchinson Cancer Center

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fred Hutchinson Cancer Center on 2026-08-17.