PLAN Intervention to Enhance Engagement of Latino Cancer Patients in Advanced Care Planning

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Latinos' Beliefs and Communication About Advance Care Planning

Conditions
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Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm

Intervention / Treatment
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* Other: Communication Intervention
* Other: Best Practice
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Identifying ethnically as Latino. Locally advanced or metastatic cancer and/or have experienced disease progression on at least first-line chemotherapy. Ability to provide informed consent. Exclusion Criteria: Not fluent in English or Spanish. Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of >= 6 to be delivered by trained study research staff during screening). Too ill or weak to complete the interviews (as judged by interviewer). Currently receiving palliative care/hospice at the time of enrollment (to allow prediction of [advanced care planning] ACP). Children and young adults under age 18. Patients deemed inappropriate for the study by their treating oncologist.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (PLAN intervention)<br>Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach. | Other: Communication Intervention<br>* Participate in PLAN intervention<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (Best practice)<br>Patients receive usual care. | Other: Best Practice<br>* Receive usual care<br>* Other names: standard therapy;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility (intervention completion) | Will be measured by intervention completion (Benchmark: >= 70% complete the intervention sessions). | One week post-intervention | 
| 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). | One week post-intervention | 
| 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. Total scores range from 6 (low) to 30 (high). | Baseline, one week post-intervention | 
| 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. Total scores range from 10 (low) to 60 (high). | Baseline, one week post-intervention | 
| 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. Total scores range from 6 (low) to 30 (high). | Baseline, one week post-intervention | 
| 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). | Baseline, one week post-intervention | 
| 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). | Baseline, one week post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advance care planning, Latinos, communication