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

Metastatic Malignant Solid Neoplasm Clinical Trial

Official title:

Latinos' Beliefs and Communication About Advance Care Planning

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04889144
• Other study ID #: RG1121949
• Secondary ID: K07CA207580NCI-2
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Fred Hutchinson Cancer Center
• Contact: Claudia De Los Santos, BS
• Phone: 206-667-1565
• Email: cdelossa[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Locally Advanced Malignant Solid Neoplasm
• Metastatic Malignant Solid Neoplasm
• Neoplasms

Intervention

Other:
• Communication Intervention
Participate in PLAN intervention
• Best Practice
Receive usual care
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas
United States	Weill Cornell Medicine	New York	New York
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington
United States	Confluence Health	Wenatchee	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility (intervention completion)	Will be measured by intervention completion (Benchmark: >= 70% complete the intervention sessions).	One week post-intervention
Primary	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").	One week post-intervention
Primary	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. Total scores range from 6 (low) to 30 (high).	Baseline, one week post-intervention
Primary	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. Total scores range from 10 (low) to 60 (high).	Baseline, one week post-intervention
Primary	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. Total scores range from 6 (low) to 30 (high).	Baseline, one week post-intervention
Primary	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).	Baseline, one week post-intervention
Primary	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).	Baseline, one week post-intervention