Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Hematologic Malignancy, Refractory Hematologic Malignancy
Conditions
Keywords
Advance Care Planning, Advance Directives, End-of-Life, Cancer
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 for up to 4 weeks and receive one check-in call on study. ARM II: Participants engage in standard care with no modifications for up to 4 weeks. After completion of study intervention, participants are followed up at 3 and 6 months.
Interventions
OTHERInternet-Based Intervention
Use smartphone application
OTHERBest Practice
Engage in standard care
OTHERTelephone-Based Intervention
Receive check-in call
OTHERQuestionnaire Administration
Ancillary studies
OTHERPost-intervention qualitative feedback interview
Post-intervention qualitative feedback interview (with a subset of patients and support persons)
Sponsors
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in completion of advance directives | 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. |
| Feasibility: Accrual rates [Patients] | 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] | 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] | At 3 months post-randomization | Will assess the percentage of enrolled patients who complete the intervention |
| Feasibility: Rates of intervention completion [Support persons] | 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] | 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] | 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] | 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] | 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] | 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] | 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] | 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] | 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] | 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] | 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] | 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 [Support persons] | 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 documentation of advance care planning conversations [Patients] | 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 [Support persons] | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in perceived social support | Baseline to 3 months | This will be assessed among patients and support persons using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12-item valid and reliable measure of social support from family, friends, and significant other, scored on a 5-point Likert scale (1=strongly disagree; 5=strongly agree), with previously reported excellent internal reliability (Cronbach's α = 0.84 to 0.92). |
| Change in treatment preference | Baseline to 3 months | This will be assessed in patients with an item used previously in our team's NCI-funded cohort studies that asks patients to express a preference for life-extending versus comfort care (two answer choices). |
| Change in healthcare utilization (summary score for total number of healthcare services utilized) | Baseline to 3 months | This measure will assess patients' receipt of life-prolonging care (number of emergency room visits, hospital admissions, length of stay in the hospital, rates of ICU admission) and use of palliative or hospice care (length and duration of palliative and/or hospice care). A total score will be created for healthcare utilization. |
| Change in number of subjects receiving goal-concordant care | Baseline to 3 months | This will be determined by comparing patients' treatment preferences to treatment received. Patients matching on their desired and received care will be designated as having received goal-concordant care. |
| Change in family functioning | Baseline to 3 months | This will be assessed among patients and support persons using the Family Relationship Index (FRI), a scale derived from the Family Environment Scale. FRI consists of 12 true/false items consisting of three subscales (cohesiveness, expressiveness, and conflict resolution) with scores ranging from 1 to 4 with higher scores indicating better family functioning. The FRI is well-validated in cancer patients. |
Countries
United States
Contacts
CONTACTClaudia De Los Santos, B.S.
CONTACTMegan Shen, PhD
PRINCIPAL_INVESTIGATORMegan J Shen, PhD
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed