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

November 2, 2023 updated by: Fred Hutchinson Cancer Center

Latinos' Beliefs and Communication About Advance Care Planning

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Terminated
        • Weill Cornell Medicine
    • Texas
      • Dallas, Texas, United States, 75390
        • Not yet recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contact:
        • Principal Investigator:
          • Elizabeth Paulk, MD
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutch/University of Washington Cancer Consortium
        • Contact:
        • Contact:
        • Principal Investigator:
          • Megan J Shen, PhD
      • Wenatchee, Washington, United States, 98801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility (intervention completion)
Time Frame: One week post-intervention
Will be measured by intervention completion (Benchmark: >= 70% complete the intervention sessions).
One week post-intervention
Acceptability (helpfulness of the intervention)
Time Frame: One week post-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
Time Frame: Baseline, one week post-intervention
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
Time Frame: Baseline, one week post-intervention
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
Time Frame: Baseline, one week post-intervention
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)
Time Frame: Baseline, one week post-intervention
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
Time Frame: Baseline, one week post-intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Megan J Shen, PhD, Fred Hutch/University of Washington Cancer Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

May 12, 2021

First Submitted That Met QC Criteria

May 12, 2021

First Posted (Actual)

May 17, 2021

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG1121949
  • K07CA207580 (U.S. NIH Grant/Contract)
  • NCI-2022-00542 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 10760 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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