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| ID | Type | Description | Link |
|---|---|---|---|
| R37CA246703 | U.S. NIH Grant/Contract | View source | |
| NCI-2022-00398 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10849 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (PACT) | Experimental | Participants use PACT mHealth app for up to 4 weeks and receive one check-in call on study. |
|
| Arm II (standard care) | Active Comparator | Participants engage in standard care with no modifications for up to 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-Based Intervention | Other | Use smartphone application |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Accrual rates [Patients] | Will assess the percentage of eligible approached patients who consent to enroll in the study | At 3 months post-randomization |
| Feasibility: Accrual rates [Support persons] | Will assess the percentage of eligible approached support persons who consent to enroll in the study | At 3 months post-randomization |
| Feasibility: Rates of intervention completion [Patients] | Will assess the percentage of enrolled patients who complete the intervention | At 3 months post-randomization |
| Feasibility: Rates of intervention completion [Support persons] | Will assess the percentage of enrolled support persons who complete the intervention | At 3 months post-randomization |
| Acceptability of the PACT application: Acceptability E-Scale [Patients] | 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. | At 3 months post-randomization |
| Acceptability of the PACT application: Acceptability E-Scale [Support persons] | 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. | At 3 months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in treatment preference | 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). | Baseline to 3 months |
| Change in treatment preference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudia De Los Santos, B.S. | Contact | 206-667-1565 | cdelossa@fredhutch.org | |
| Megan Shen, PhD | Contact | 206-667-4172 | mshen2@fredhutch.org |
| Name | Affiliation | Role |
|---|---|---|
| Megan J Shen, PhD | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwell Health | Not yet recruiting | Manhasset | New York | 11030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 5212297 | Background | Karnofsky DA. Determining the extent of the cancer and clinical planning for cure. Cancer. 1968 Oct;22(4):730-4. doi: 10.1002/1097-0142(196810)22:43.0.co;2-h. | |
| 20974066 | Background | Tariman JD, Berry DL, Halpenny B, Wolpin S, Schepp K. Validation and testing of the Acceptability E-scale for web-based patient-reported outcomes in cancer care. Appl Nurs Res. 2011 Feb;24(1):53-8. doi: 10.1016/j.apnr.2009.04.003. Epub 2009 Sep 18. |
| Label | URL |
|---|---|
| Usability.gov. System Usability Scale (SUS) | View source |
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| Best Practice |
| Other |
Engage in standard care |
|
|
| Telephone-Based Intervention | Other | Receive check-in call |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Post-intervention qualitative feedback interview | Other | Post-intervention qualitative feedback interview (with a subset of patients and support persons) |
|
| Usability of the PACT application: System Usability Scale (SUS) [Patients] | 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 | At 3 months post-randomization |
| Usability of the PACT application: System Usability Scale (SUS) [Support persons] | 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 | At 3 months post-randomization |
| User satisfaction [Patients] | 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 | At 3 months post-randomization |
| User satisfaction [Support persons] | 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 | At 3 months post-randomization |
| User engagement as measured by number of views [Patients] | User engagement will be assessed through tracking of activity (i.e., number of views) over a 3-month period following randomization. | Baseline to 3 months post-intervention |
| User engagement as measured by number of views [Support persons] | User engagement will be assessed through tracking of activity (i.e., number of views) over a 3-month period following randomization. | Baseline to 3 months post-intervention |
| User engagement as measured by time spent on app [Patients] | User engagement will be assessed through tracking of activity (i.e., time spent on app) over a 3-month period following randomization. | Baseline to 3 months post-intervention |
| User engagement as measured by time spent on app [Support persons] | User engagement will be assessed through tracking of activity (i.e., time spent on app) over a 3-month period following randomization. | Baseline to 3 months post-intervention |
| Change in level of engagement in advance care planning [Patients] | 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). | Baseline to 3 months post-intervention |
| Change in level of engagement in advance care planning [Patients] | 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). | Baseline to 6 months post-intervention |
| Change in level of engagement in advance care planning [Support persons] | 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). | Baseline to 3 months post-intervention |
| Change in level of engagement in advance care planning [Support persons] | 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). | Baseline to 6 months post-intervention |
| Change in documentation of advance care planning conversations [Patients] | 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). | Baseline to 3 months post-intervention |
| Change in documentation of advance care planning conversations [Patients] | 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). | Baseline to 6 months post-intervention |
| Change in documentation of advance care planning conversations [Support persons] | 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). | Baseline to 3 months post-intervention |
| Change in documentation of advance care planning conversations [Support persons] | 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). | Baseline to 6 months post-intervention |
| Change in completion of advance directives | 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. | Baseline to 3 months post-intervention |
| Change in completion of advance directives | 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. | Baseline to 6 months post-intervention |
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). |
| Baseline to 6 months |
| Change in healthcare utilization (summary score for total number of healthcare services utilized) | 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. | Baseline to 3 months |
| Change in healthcare utilization (summary score for total number of healthcare services utilized) | 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. | Baseline to 6 months |
| Change in number of subjects receiving goal-concordant care | 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. | Baseline to 3 months |
| Change in number of subjects receiving goal-concordant care | 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. | Baseline to 6 months |
| Change in perceived social support | 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). | Baseline to 3 months |
| Change in perceived social support | 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). | Baseline to 6 months |
| Change in family functioning | 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. | Baseline to 3 months |
| Change in family functioning | 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. | Baseline to 6 months |
| Mount Sinai Hospital | Active, not recruiting | New York | New York | 10029 | United States |
| NYP/Weill Cornell Medical Center | Not yet recruiting | New York | New York | 10065 | United States |
|
| Fred Hutch/University of Washington Cancer Consortium | Recruiting | Seattle | Washington | 98109 | United States |
|
| Background | S. Summers and A. Watt, |
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| Measuring Usability with the System Usability Scale | View source |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D019337 | Hematologic Neoplasms |
| D003643 | Death |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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