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

NCT04889144 | Completed Results

• 4 other identifiers: RG1121949K07CA207580NCI-2022-0054210760
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

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.

Conditions

Locally Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm

Keywords

advance care planning; Latinos; communication

Outcome Measures

Primary Outcomes (7)

• 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.

  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)

Study Arms (2)

Arm I (PLAN intervention)

EXPERIMENTAL

Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach.

Other: Communication Intervention; Other: Questionnaire Administration

Arm II (Best practice)

ACTIVE COMPARATOR

Patients receive usual care.

Other: Best Practice; Other: Questionnaire Administration

Interventions

Communication Intervention OTHER

Participate in PLAN intervention

Arm I (PLAN intervention)

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm II (Best practice)

Questionnaire Administration OTHER

Ancillary studies

Arm I (PLAN intervention); Arm II (Best practice)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Confluence Health

Wenatchee, Washington, 98801, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Communication

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Results Point of Contact

• Title: Megan Shen, Associate Professor
• Organization: Fred Hutchinson Cancer Center

mshen2@fredhutch.org

206-667-4172

Study Officials

• Megan J Shen, PhD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 17, 2021
• Study Start: January 1, 2021
• Primary Completion: February 12, 2025
• Study Completion: June 16, 2025
• Last Updated: September 9, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)