Clinical trial NCT04889144: PLAN Intervention to Enhance Engagement of Latino Cancer Patients in Advanced Care Planning
Official title: Latinos' Beliefs and Communication About Advance Care Planning
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Locally Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Keywords: advance care planning
Latinos
communication
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-05-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility (intervention completion)
timeFrame: One week post-intervention
measure: Acceptability (helpfulness of the intervention)
timeFrame: One week post-intervention
measure: Change in knowledge of advance care planning
timeFrame: Baseline, one week post-intervention
measure: Change in readiness/motivation to engage in advance care planning
timeFrame: Baseline, one week post-intervention
measure: Change in self-efficacy to engage in advance care planning
timeFrame: Baseline, one week post-intervention
measure: Change in engagement in advance care planning (end-of-life care discussions)
timeFrame: Baseline, one week post-intervention
measure: Change in completion of advance directives
timeFrame: Baseline, one week post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Dallas
country: United States
facility: UT Southwestern/Simmons Cancer Center-Dallas
state: Texas
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
city: Wenatchee
country: United States
facility: Confluence Health
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Megan J Shen, PhD
role: PRINCIPAL_INVESTIGATOR
References: