Skip to content

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

Latinos' Beliefs and Communication About Advance Care Planning

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04889144
Enrollment
27
Registered
2021-05-17
Start date
2021-01-01
Completion date
2025-06-16
Last updated
2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm

Keywords

advance care planning, Latinos, communication

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.

Interventions

OTHERCommunication Intervention

Participate in PLAN intervention

OTHERBest Practice

Receive usual care

OTHERQuestionnaire Administration

Ancillary studies

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Fred Hutchinson Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility (Number/Proportion of Participants Who Completed the Intervention)Five weeks post-randomization (for intervention arm only)Will be measured by intervention completion (Benchmark: \>= 70% complete the intervention sessions).
Acceptability (Helpfulness of the Intervention)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.
Change in Knowledge of Advance Care PlanningBaseline, 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.
Change in Readiness/Motivation to Engage in Advance Care PlanningBaseline, 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.
Change in Self-efficacy to Engage in Advance Care PlanningBaseline, 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.
Change in Engagement in Advance Care Planning (End-of-life Care Discussions)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,
Change in Completion of Advance DirectivesBaseline, 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.

Countries

United States

Participant flow

Pre-assignment details

Please note that a total of n=27 patients enrolled in this study, n=22 completed baseline, and n=20 were randomized. As such, we can only provide baseline characteristics by intervention group for n=20 patients. Additionally, n=11 patients completed follow-up surveys, so all data reporting requiring follow-up data is provided for those n=11 patients.

Participants by arm

ArmCount
Arm I (PLAN Intervention)
Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach. Communication Intervention: Participate in PLAN intervention Questionnaire Administration: Ancillary studies
11
Arm II (Best Practice)
Patients receive usual care. Best Practice: Receive usual care Questionnaire Administration: Ancillary studies
9
Total20

Baseline characteristics

CharacteristicArm I (PLAN Intervention)TotalArm II (Best Practice)
Age, Continuous52.3 years
STANDARD_DEVIATION 9.31
51.4 years
STANDARD_DEVIATION 10.29
50.2 years
STANDARD_DEVIATION 12.1
Ethnicity (NIH/OMB)
Hispanic or Latino
11 Participants20 Participants9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants13 Participants8 Participants
Race (NIH/OMB)
White
4 Participants5 Participants1 Participants
Region of Enrollment
United States
11 participants20 participants9 participants
Sex/Gender, Customized
Female
2 Participants7 Participants5 Participants
Sex/Gender, Customized
Male
8 Participants12 Participants4 Participants
Sex/Gender, Customized
Other
1 Participants1 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 110 / 9
other
Total, other adverse events
0 / 110 / 9
serious
Total, serious adverse events
0 / 110 / 9

Outcome results

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

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

Population: Please note: Only participants who completed the intervention were assessed for this outcome measure.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Arm I (PLAN Intervention)Acceptability (Helpfulness of the Intervention)Reported 4=helpful0 Participants
Arm I (PLAN Intervention)Acceptability (Helpfulness of the Intervention)Reported 5=very helpful5 Participants
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). Data reported is the mean change in this outcome from pre-randomization/baseline to post-randomization.

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

Population: Due to the small sample size, inferential statistics were not run. Only participants who completed all study activities (e.g., follow-up surveys) were assessed for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Arm I (PLAN Intervention)Change in Completion of Advance Directives0.0 score on a scaleStandard Deviation 0.82
Arm II (Best Practice)Change in Completion of Advance Directives0.43 score on a scaleStandard Deviation 0.53
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). Data reported is the mean change in this outcome from pre-randomization/baseline to post-randomization,

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

Population: Due to the small sample size, inferential statistics were not run. Only participants who completed all study activities (e.g., follow-up surveys) were assessed for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Arm I (PLAN Intervention)Change in Engagement in Advance Care Planning (End-of-life Care Discussions)2.50 score on a scaleStandard Deviation 1.73
Arm II (Best Practice)Change in Engagement in Advance Care Planning (End-of-life Care Discussions)1.29 score on a scaleStandard Deviation 3.2
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. 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.

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

Population: Due to the small sample size, inferential statistics were not run. Only participants who completed all study activities (e.g., follow-up surveys) were assessed for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Arm I (PLAN Intervention)Change in Knowledge of Advance Care Planning2.75 score on a scaleStandard Deviation 3.4
Arm II (Best Practice)Change in Knowledge of Advance Care Planning1.86 score on a scaleStandard Deviation 3.48
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. 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.

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

Population: Due to the small sample size, inferential statistics were not run. Only participants who completed all study activities (e.g., follow-up surveys) were assessed for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Arm I (PLAN Intervention)Change in Readiness/Motivation to Engage in Advance Care Planning10.0 score on a scaleStandard Deviation 18.89
Arm II (Best Practice)Change in Readiness/Motivation to Engage in Advance Care Planning1.0 score on a scaleStandard Deviation 6.08
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. 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.

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

Population: Due to the small sample size, inferential statistics were not run. Only participants who completed all study activities (e.g., follow-up surveys) were assessed for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Arm I (PLAN Intervention)Change in Self-efficacy to Engage in Advance Care Planning0.00 score on a scaleStandard Deviation 4.27
Arm II (Best Practice)Change in Self-efficacy to Engage in Advance Care Planning0.86 score on a scaleStandard Deviation 5.3
Primary

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

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

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

Population: Please note: Only participants assigned to the intervention arm (Arm 1) were assessed for this outcome measure.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm I (PLAN Intervention)Feasibility (Number/Proportion of Participants Who Completed the Intervention)5 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026