NCT04515810 · Fred Hutchinson Cancer Center
Mobile Health Application (PACT) to Improve Engagement in Advance Care Planning
What this study is 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.
View original scientific description
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.
Interventions
OTHER
Internet-Based Intervention
Use smartphone application
OTHER
Best Practice
Engage in standard care
OTHER
Telephone-Based Intervention
Receive check-in call
OTHER
Questionnaire Administration
Ancillary studies
OTHER
Post-intervention qualitative feedback interview
Post-intervention qualitative feedback interview (with a subset of patients and support persons)
Primary outcome measures
Feasibility: Accrual rates [Patients]
Time frame: At 3 months post-randomization
Will assess the percentage of eligible approached patients who consent to enroll in the study
Feasibility: Accrual rates [Support persons]
Time frame: At 3 months post-randomization
Will assess the percentage of eligible approached support persons who consent to enroll in the study
Feasibility: Rates of intervention completion [Patients]
Time frame: At 3 months post-randomization
Will assess the percentage of enrolled patients who complete the intervention
Feasibility: Rates of intervention completion [Support persons]
Time frame: At 3 months post-randomization
Will assess the percentage of enrolled support persons who complete the intervention
Acceptability of the PACT application: Acceptability E-Scale [Patients]
Time frame: At 3 months post-randomization
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.
Acceptability of the PACT application: Acceptability E-Scale [Support persons]
Time frame: At 3 months post-randomization
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.
Usability of the PACT application: System Usability Scale (SUS) [Patients]
Time frame: At 3 months post-randomization
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
Usability of the PACT application: System Usability Scale (SUS) [Support persons]
Time frame: At 3 months post-randomization
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
User satisfaction [Patients]
Time frame: At 3 months post-randomization
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
User satisfaction [Support persons]
Time frame: At 3 months post-randomization
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
User engagement as measured by number of views [Patients]
Time frame: Baseline to 3 months post-intervention
User engagement will be assessed through tracking of activity (i.e., number of views) over a 3-month period following randomization.
User engagement as measured by number of views [Support persons]
Time frame: Baseline to 3 months post-intervention
User engagement will be assessed through tracking of activity (i.e., number of views) over a 3-month period following randomization.
User engagement as measured by time spent on app [Patients]
Time frame: Baseline to 3 months post-intervention
User engagement will be assessed through tracking of activity (i.e., time spent on app) over a 3-month period following randomization.
User engagement as measured by time spent on app [Support persons]
Time frame: Baseline to 3 months post-intervention
User engagement will be assessed through tracking of activity (i.e., time spent on app) over a 3-month period following randomization.
Change in level of engagement in advance care planning [Patients]
Time frame: Baseline to 3 months post-intervention
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).
Change in level of engagement in advance care planning [Patients]
Time frame: Baseline to 6 months post-intervention
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).
Change in level of engagement in advance care planning [Support persons]
Time frame: Baseline to 3 months post-intervention
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).
Change in level of engagement in advance care planning [Support persons]
Time frame: Baseline to 6 months post-intervention
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).
Change in documentation of advance care planning conversations [Patients]
Time frame: Baseline to 3 months post-intervention
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).
Change in documentation of advance care planning conversations [Patients]
Time frame: Baseline to 6 months post-intervention
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).
Change in documentation of advance care planning conversations [Support persons]
Time frame: Baseline to 3 months post-intervention
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).
Change in documentation of advance care planning conversations [Support persons]
Time frame: Baseline to 6 months post-intervention
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).
Change in completion of advance directives
Time frame: Baseline to 3 months post-intervention
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.
Change in completion of advance directives
Time frame: Baseline to 6 months post-intervention
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Manhasset, New York
- New York, New York
- Seattle, Washington
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 17, 2026 · Source of record for eligibility and locations