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

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04889144
Collaborator
National Cancer Institute (NCI) (NIH)
50
4
2
35.9
12.5
0.3

Study Details

Study Description

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. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Communication Intervention
  • Other: Best Practice
  • Other: Questionnaire Administration
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Latinos' Beliefs and Communication About Advance Care Planning
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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: Communication Intervention
Participate in PLAN intervention

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Arm II (Best practice)

Patients receive usual care.

Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy
  • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility (intervention completion) [One week post-intervention]

      Will be measured by intervention completion (Benchmark: >= 70% complete the intervention sessions).

    2. Acceptability (helpfulness of the intervention) [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").

    3. Change in knowledge of advance care planning [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).

    4. Change in readiness/motivation to engage in advance care planning [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).

    5. Change in self-efficacy to engage in advance care planning [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).

    6. Change in engagement in advance care planning (end-of-life care discussions) [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).

    7. Change in completion of advance directives [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Identifying ethnically as Latino.

    • Locally advanced or metastatic cancer (pancreaticobiliary, esophagogastric, hepatocellular carcinoma, lung, or gynecological cancer) AND 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 21.

    • Patients deemed inappropriate for the study by their treating oncologist.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Weill Cornell Medicine New York New York United States 10021
    2 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    3 Fred Hutch/University of Washington Cancer Consortium Seattle Washington United States 98109
    4 Confluence Health Wenatchee Washington United States 98801

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fred Hutchinson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04889144
    Other Study ID Numbers:
    • RG1121949
    • K07CA207580
    • NCI-2022-00542
    • 10760
    First Posted:
    May 17, 2021
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fred Hutchinson Cancer Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 30, 2022