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| ID | Type | Description | Link |
|---|---|---|---|
| K07CA207580 | U.S. NIH Grant/Contract | View source | |
| NCI-2022-00542 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10760 | 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 trial tests whether Planning for Your Advance Care Needs (PLAN) intervention works to enhance Latino patients' understanding of and engagement in advanced care planning. The PLAN intervention may be an effective method to help people with cancer plan for and talk about advance care planning (the care they would want if they were unable to communicate) with their loved ones and doctors.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach.
ARM II: Patients receive usual care.
After completion of study treatment, patients are followed up at 1 week and then at 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (PLAN intervention) | Experimental | Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach. |
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| Arm II (Best practice) | Active Comparator | Patients receive usual care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Communication Intervention | Other | Participate in PLAN intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility (Number/Proportion of Participants Who Completed the Intervention) | Will be measured by intervention completion (Benchmark: >= 70% complete the intervention sessions). | Five weeks post-randomization (for intervention arm only) |
| Acceptability (Helpfulness of the Intervention) | Will be measured by a single-item question assessing helpfulness of the intervention (1 = not at all helpful, 5 = very helpful) as well an open-ended question about helpfulness of the intervention ("What was helpful about the intervention?") (Benchmark: >= 70% rate it as "helpful" or "very helpful"). Data reported as a count number of those who reported "4=helpful" or "5=very helpful" to this question. | Five weeks post-randomization (for intervention arm only) |
| Change in Knowledge of Advance Care Planning | Knowledge subscale of the Advance Care Planning Engagement survey, which is a 49-item scale with high reliability (Cronbach's alpha = .94). Subscale is 6 items with Likert-type answers ranging from 1=not at all to 5=extremely. Responses to these 6 items are summed to create total scores, ranging from 6 (low levels of knowledge) to 30 (high levels of knowledge). Higher scores indicate higher levels of knowledge. Mean score differences were calculated between baseline and follow-up for each study arm and tested for significance. | Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned) |
| Change in Readiness/Motivation to Engage in Advance Care Planning | Readiness/motivation subscale of the Advance Care Planning Engagement survey, which is a 49-item scale with high reliability (Cronbach's alpha = .94). Subscale is 10 items with Likert-type answers ranging from 1=not at all to 5=extremely. Scores from these items are summed to created total scores, ranging from 10 (low level of readiness/motivation) to 60 (high level of readiness/motivation). Higher scores indicate higher levels of readiness/motivation. Mean score differences were calculated between baseline and follow-up for each study arm and tested for significance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan J Shen, PhD | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10021 | United States | ||
| UT Southwestern/Simmons Cancer Center-Dallas |
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Please note that a total of n=27 patients enrolled in this study, n=22 completed baseline, and n=20 were randomized. As such, we can only provide baseline characteristics by intervention group for n=20 patients. Additionally, n=11 patients completed follow-up surveys, so all data reporting requiring follow-up data is provided for those n=11 patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (PLAN Intervention) | Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach. Communication Intervention: Participate in PLAN intervention Questionnaire Administration: Ancillary studies |
| FG001 | Arm II (Best Practice) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2024 |
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| Best Practice |
| Other |
Receive usual care |
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| Questionnaire Administration | Other | Ancillary studies |
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| Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned) |
| Change in Self-efficacy to Engage in Advance Care Planning | Self-efficacy subscale of the Advance Care Planning Engagement survey, which is a 49-item scale with high reliability (Cronbach's alpha = .94). Subscale is 6 items with Likert-type answers ranging from 1=not at all to 5=extremely. These items are summed to create total scores, ranging from 6 (low levels of self-efficacy) to 30 (high levels of self-efficacy). Higher scores indicated higher levels of self-efficacy. Mean score differences were calculated between baseline and follow-up for each study arm and tested for significance. Data reported is the mean change in this outcome from pre-randomization/baseline to post-randomization. | Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned) |
| Change in Engagement in Advance Care Planning (End-of-life Care Discussions) | End-of-life care discussions will be measured by asking patients to self-report whether they have discussed any of the following: (1) wishes they have about the care they would like to receive if they were dying and/or (2) advance care directives, with an oncology provider or family member: DNR orders, living wills, durable powers of attorney for health care (yes/no format). Engagement will be measured as a count to the degree to which they engaged in each of these, with no=0 and yes=1. Total score can range from 0 (low or none) to 8 (high or discussed all domains with providers and family). Data reported is the mean change in this outcome from pre-randomization/baseline to post-randomization, | Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned) |
| Change in Completion of Advance Directives | Completion of advance directives will be assessed by examining the medical chart for completed advance directive documents (DNR order, living will, health care proxy/durable power of attorney). Completion will be measured as a count to the degree to which they completed each of these, with no=0 and yes=1. Scores can range from 0 (low or none completed) to 3 (high or all completed). Data reported is the mean change in this outcome from pre-randomization/baseline to post-randomization. | Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned) |
| Dallas |
| Texas |
| 75390 |
| United States |
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| Confluence Health | Wenatchee | Washington | 98801 | United States |
Patients receive usual care. Best Practice: Receive usual care Questionnaire Administration: Ancillary studies |
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| NOT COMPLETED |
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A total of n=27 patients enrolled in this study, n=22 completed baseline, n=20 were randomized (individuals we have data on baseline characteristics and arm/condition assignment), and n=11 we have baseline and follow-up data for. As such, baseline characeteristics are reported for n=20 patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (PLAN Intervention) | Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach. Communication Intervention: Participate in PLAN intervention Questionnaire Administration: Ancillary studies |
| BG001 | Arm II (Best Practice) | Patients receive usual care. Best Practice: Receive usual care Questionnaire Administration: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | For age, n=1 patient in the control condition did not provide a value so only n=8 are reported out of the n=9 who completed the baseline. Similarly, n=19 are reported out of n=20 for the overall column. | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Please note, that we had a category for "Other (Hispanic/Latino)" as many patients do not identify with a racial category who identify as Hispanic/Latino. In this study, n=3 (intervention) and n=8 (control) who are listed as "Not reported" chose "Other (Hispanic/Latino)." | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility (Number/Proportion of Participants Who Completed the Intervention) | Will be measured by intervention completion (Benchmark: >= 70% complete the intervention sessions). | Please note: Only participants assigned to the intervention arm (Arm 1) were assessed for this outcome measure. | Posted | Count of Participants | Participants | Five weeks post-randomization (for intervention arm only) |
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| Primary | Acceptability (Helpfulness of the Intervention) | Will be measured by a single-item question assessing helpfulness of the intervention (1 = not at all helpful, 5 = very helpful) as well an open-ended question about helpfulness of the intervention ("What was helpful about the intervention?") (Benchmark: >= 70% rate it as "helpful" or "very helpful"). Data reported as a count number of those who reported "4=helpful" or "5=very helpful" to this question. | Please note: Only participants who completed the intervention were assessed for this outcome measure. | Posted | Count of Participants | Participants | Five weeks post-randomization (for intervention arm only) |
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| Primary | Change in Knowledge of Advance Care Planning | Knowledge subscale of the Advance Care Planning Engagement survey, which is a 49-item scale with high reliability (Cronbach's alpha = .94). Subscale is 6 items with Likert-type answers ranging from 1=not at all to 5=extremely. Responses to these 6 items are summed to create total scores, ranging from 6 (low levels of knowledge) to 30 (high levels of knowledge). Higher scores indicate higher levels of knowledge. Mean score differences were calculated between baseline and follow-up for each study arm and tested for significance. | Due to the small sample size, inferential statistics were not run. Only participants who completed all study activities (e.g., follow-up surveys) were assessed for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned) |
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| Primary | Change in Readiness/Motivation to Engage in Advance Care Planning | Readiness/motivation subscale of the Advance Care Planning Engagement survey, which is a 49-item scale with high reliability (Cronbach's alpha = .94). Subscale is 10 items with Likert-type answers ranging from 1=not at all to 5=extremely. Scores from these items are summed to created total scores, ranging from 10 (low level of readiness/motivation) to 60 (high level of readiness/motivation). Higher scores indicate higher levels of readiness/motivation. Mean score differences were calculated between baseline and follow-up for each study arm and tested for significance. | Due to the small sample size, inferential statistics were not run. Only participants who completed all study activities (e.g., follow-up surveys) were assessed for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned) |
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| Primary | Change in Self-efficacy to Engage in Advance Care Planning | Self-efficacy subscale of the Advance Care Planning Engagement survey, which is a 49-item scale with high reliability (Cronbach's alpha = .94). Subscale is 6 items with Likert-type answers ranging from 1=not at all to 5=extremely. These items are summed to create total scores, ranging from 6 (low levels of self-efficacy) to 30 (high levels of self-efficacy). Higher scores indicated higher levels of self-efficacy. Mean score differences were calculated between baseline and follow-up for each study arm and tested for significance. Data reported is the mean change in this outcome from pre-randomization/baseline to post-randomization. | Due to the small sample size, inferential statistics were not run. Only participants who completed all study activities (e.g., follow-up surveys) were assessed for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned) |
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| Primary | Change in Engagement in Advance Care Planning (End-of-life Care Discussions) | End-of-life care discussions will be measured by asking patients to self-report whether they have discussed any of the following: (1) wishes they have about the care they would like to receive if they were dying and/or (2) advance care directives, with an oncology provider or family member: DNR orders, living wills, durable powers of attorney for health care (yes/no format). Engagement will be measured as a count to the degree to which they engaged in each of these, with no=0 and yes=1. Total score can range from 0 (low or none) to 8 (high or discussed all domains with providers and family). Data reported is the mean change in this outcome from pre-randomization/baseline to post-randomization, | Due to the small sample size, inferential statistics were not run. Only participants who completed all study activities (e.g., follow-up surveys) were assessed for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned) |
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| Primary | Change in Completion of Advance Directives | Completion of advance directives will be assessed by examining the medical chart for completed advance directive documents (DNR order, living will, health care proxy/durable power of attorney). Completion will be measured as a count to the degree to which they completed each of these, with no=0 and yes=1. Scores can range from 0 (low or none completed) to 3 (high or all completed). Data reported is the mean change in this outcome from pre-randomization/baseline to post-randomization. | Due to the small sample size, inferential statistics were not run. Only participants who completed all study activities (e.g., follow-up surveys) were assessed for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned) |
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All participants were monitored for AEs/SAEs during the entire enrollment period from the point of consent until the final follow-up survey. This time frame was up to n=11.6 weeks (maximum) and was n=4.0 weeks on average.
We did both systematic reporting (checking medical records for hospitalizations and/or death) as well as non-systematic reporting (noting when a patient mentioned distress, hospitalization, etc.).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (PLAN Intervention) | Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach. Communication Intervention: Participate in PLAN intervention Questionnaire Administration: Ancillary studies | 0 | 11 | 0 | 11 | 0 | 11 |
| EG001 | Arm II (Best Practice) | Patients receive usual care. Best Practice: Receive usual care Questionnaire Administration: Ancillary studies | 0 | 9 | 0 | 9 | 0 | 9 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Megan Shen, Associate Professor | Fred Hutchinson Cancer Center | 206-667-4172 | mshen2@fredhutch.org |
| Jun 24, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 5, 2024 | May 30, 2025 | ICF_000.pdf |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D003142 | Communication |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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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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