Planning Advance Care Together (PACT) to Improve Engagement in Advance Care Planning
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Malignant Solid Neoplasm
- Sponsor
- Fred Hutchinson Cancer Center
- Enrollment
- 400
- Locations
- 4
- Primary Endpoint
- Feasibility: Accrual rates [Support persons]
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
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.
Investigators
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.
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
- •PATIENT: Resides outside of the United States.
- •SUPPORT PERSON AND PROVIDERS: Resides outside of the United States.
Outcomes
Primary Outcomes
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
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
Feasibility: Rates of intervention completion [Patients]
Time Frame: At 3 months post-randomization
Will assess the percentage of enrolled patients who complete the intervention
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.
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 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 [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).
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
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.
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
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.
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
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
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 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.
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 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 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).
Secondary Outcomes
- 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 6 months)
- Change in perceived social support(Baseline to 6 months)
- Change in treatment preference(Baseline to 6 months)
- Change in family functioning(Baseline to 6 months)