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Completed

NCT Number: NCT04889144

PLAN Intervention to Enhance Engagement of Latino Cancer Patients in Advanced 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Communication intervention

Other

Participate in PLAN intervention

Best Practice

Other

Receive usual care

Other names: standard of care, standard therapy

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Feasibility (Number/Proportion of Participants Who Completed the Intervention)

    Time frame: Five weeks post-randomization (for intervention arm only)

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

  2. Acceptability (Helpfulness of the Intervention)

    Time frame: Five weeks post-randomization (for intervention arm only)

    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"). Data reported as a count number of those who reported "4=helpful" or "5=very helpful" to this question.

  3. Change in Knowledge of Advance Care Planning

    Time frame: Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)

    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. Responses to these 6 items are summed to create total scores, ranging from 6 (low levels of knowledge) to 30 (high levels of knowledge). Higher scores indicate higher levels of knowledge. Mean score differences were calculated between baseline and follow-up for each study arm and tested for significance.

  4. Change in Readiness/Motivation to Engage in Advance Care Planning

    Time frame: Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)

    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. Scores from these items are summed to created total scores, ranging from 10 (low level of readiness/motivation) to 60 (high level of readiness/motivation). Higher scores indicate higher levels of readiness/motivation. Mean score differences were calculated between baseline and follow-up for each study arm and tested for significance.

  5. Change in Self-efficacy to Engage in Advance Care Planning

    Time frame: Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)

    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. These items are summed to create total scores, ranging from 6 (low levels of self-efficacy) to 30 (high levels of self-efficacy). Higher scores indicated higher levels of self-efficacy. Mean score differences were calculated between baseline and follow-up for each study arm and tested for significance.

    Data reported is the mean change in this outcome from pre-randomization/baseline to post-randomization.

  6. Change in Engagement in Advance Care Planning (End-of-life Care Discussions)

    Time frame: Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)

    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). Data reported is the mean change in this outcome from pre-randomization/baseline to post-randomization,

  7. Change in Completion of Advance Directives

    Time frame: Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)

    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). Data reported is the mean change in this outcome from pre-randomization/baseline to post-randomization.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Latinos' Beliefs and Communication About Advance Care Planning

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 17, 2021
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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