Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
Conditions
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
Participate in PLAN intervention
Receive usual care
Ancillary studies
Sponsors
Study design
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Planning | 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. |
| Change in Readiness/Motivation to Engage in Advance Care Planning | 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. |
| Change in Self-efficacy to Engage in Advance Care Planning | 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. |
| 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 Directives | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 20 |
Baseline characteristics
| Characteristic | Arm I (PLAN Intervention) | Total | Arm II (Best Practice) |
|---|---|---|---|
| Age, Continuous | 52.3 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 Participants | 20 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 13 Participants | 8 Participants |
| Race (NIH/OMB) White | 4 Participants | 5 Participants | 1 Participants |
| Region of Enrollment United States | 11 participants | 20 participants | 9 participants |
| Sex/Gender, Customized Female | 2 Participants | 7 Participants | 5 Participants |
| Sex/Gender, Customized Male | 8 Participants | 12 Participants | 4 Participants |
| Sex/Gender, Customized Other | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 9 |
| other Total, other adverse events | 0 / 11 | 0 / 9 |
| serious Total, serious adverse events | 0 / 11 | 0 / 9 |
Outcome results
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (PLAN Intervention) | Acceptability (Helpfulness of the Intervention) | Reported 4=helpful | 0 Participants |
| Arm I (PLAN Intervention) | Acceptability (Helpfulness of the Intervention) | Reported 5=very helpful | 5 Participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (PLAN Intervention) | Change in Completion of Advance Directives | 0.0 score on a scale | Standard Deviation 0.82 |
| Arm II (Best Practice) | Change in Completion of Advance Directives | 0.43 score on a scale | Standard Deviation 0.53 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (PLAN Intervention) | Change in Engagement in Advance Care Planning (End-of-life Care Discussions) | 2.50 score on a scale | Standard Deviation 1.73 |
| Arm II (Best Practice) | Change in Engagement in Advance Care Planning (End-of-life Care Discussions) | 1.29 score on a scale | Standard Deviation 3.2 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (PLAN Intervention) | Change in Knowledge of Advance Care Planning | 2.75 score on a scale | Standard Deviation 3.4 |
| Arm II (Best Practice) | Change in Knowledge of Advance Care Planning | 1.86 score on a scale | Standard Deviation 3.48 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (PLAN Intervention) | Change in Readiness/Motivation to Engage in Advance Care Planning | 10.0 score on a scale | Standard Deviation 18.89 |
| Arm II (Best Practice) | Change in Readiness/Motivation to Engage in Advance Care Planning | 1.0 score on a scale | Standard Deviation 6.08 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (PLAN Intervention) | Change in Self-efficacy to Engage in Advance Care Planning | 0.00 score on a scale | Standard Deviation 4.27 |
| Arm II (Best Practice) | Change in Self-efficacy to Engage in Advance Care Planning | 0.86 score on a scale | Standard Deviation 5.3 |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I (PLAN Intervention) | Feasibility (Number/Proportion of Participants Who Completed the Intervention) | 5 Participants |