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

Not Applicable

Completed

Conditions: Metastatic Malignant Solid Neoplasm
Locally Advanced Malignant Solid Neoplasm

Registration Number: NCT04889144

Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 27

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility (Number/Proportion of Participants Who Completed the Intervention)	Five weeks post-randomization (for intervention arm only)	Will be measured by intervention completion (Benchmark: \>= 70% complete the intervention sessions).
Acceptability (Helpfulness of the Intervention)	Five weeks post-randomization (for intervention arm only)	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.
Change in Knowledge of Advance Care Planning	Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)	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.
Change in Readiness/Motivation to Engage in Advance Care Planning	Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)	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.
Change in Self-efficacy to Engage in Advance Care Planning	Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)	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.
Change in Engagement in Advance Care Planning (End-of-life Care Discussions)	Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)	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,
Change in Completion of Advance Directives	Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (4): Weill Cornell Medicine
🇺🇸
New York, New York, United States
UT Southwestern/Simmons Cancer Center-Dallas
🇺🇸
Dallas, Texas, United States
Fred Hutch/University of Washington Cancer Consortium
🇺🇸
Seattle, Washington, United States
Confluence Health
🇺🇸
Wenatchee, Washington, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States