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

NCT ID: NCT04889144

Last Updated: 2025-09-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-06-16

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.

Conditions

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Locally Advanced Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm I (PLAN intervention)

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

Group Type EXPERIMENTAL

Communication Intervention

Intervention Type OTHER

Participate in PLAN intervention

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm II (Best practice)

Patients receive usual care.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive usual care

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Communication Intervention

Participate in PLAN intervention

Intervention Type OTHER

Best Practice

Receive usual care

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Megan Shen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Megan J Shen, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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Weill Cornell Medicine

New York, New York, United States

Site Status

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Confluence Health

Wenatchee, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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K07CA207580

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2022-00542

Identifier Type: REGISTRY

Identifier Source: secondary_id

10760

Identifier Type: OTHER

Identifier Source: secondary_id

RG1121949

Identifier Type: -

Identifier Source: org_study_id

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