Locally Advanced Malignant Solid NeoplasmNCT04889144
PLAN Intervention to Enhance Engagement of Latino Cancer Patients in Advanced Care Planning
A study testing Communication Intervention, Best Practice and Questionnaire Administration in people with Locally Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, run by Fred Hutchinson Cancer Center at 4 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
- What is being tested?
- Communication Intervention, Best Practice and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jan 2021to 16 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Weill Cornell Medicine
New York, New York, 10021
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Confluence Health
Wenatchee, Washington, 98801
About this study
Official title: Latinos' Beliefs and Communication About Advance 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.
Read the 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.
- Being tested
- Communication Intervention, Best Practice, Questionnaire Administration
- Keywords
- advance care planning, Latinos, communication
- Medical subject headings
- Neoplasm Metastasis, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication InterventionOther
Participate in PLAN intervention
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (PLAN intervention) | Experimental | Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach. Receives: Other: Communication Intervention; Other: Questionnaire Administration |
| Arm II (Best practice) | Active comparator | Patients receive usual care. Receives: Other: Best Practice; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (Number/Proportion of Participants Who Completed the Intervention)
Will be measured by intervention completion (Benchmark: >= 70% complete the intervention sessions).
Measured: Five weeks post-randomization (for intervention arm only)
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.
Measured: Five weeks post-randomization (for intervention arm only)
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.
Measured: Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)
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.
Measured: Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)
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.
Measured: Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)
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,
Measured: Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)
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.
Measured: Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Jan 2021
- Primary completion12 Feb 2025
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Locally Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Megan Shen, Fred Hutchinson Cancer Center
- Investigators
- Megan J Shen, PhD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889144
- Sponsor's protocol ID
- RG1121949
- Other IDs
- K07CA207580, NCI-2022-00542, 10760
- Status last verified
- Aug 2025
- First submitted
- 12 May 2021
- Last updated
- 9 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latinos' Beliefs and Communication About Advance Care Planning
- ClinicalTrials.gov ID
- NCT04889144
- Acronym / sponsor ID
- RG1121949
- Keywords
- advance care planning, Latinos, communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Posted 14 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (PLAN intervention) | Experimental | Other: Communication Intervention, Other: Questionnaire AdministrationPatients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach. |
| Arm II (Best practice) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationPatients receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication InterventionParticipate in PLAN intervention | Other | Arm I (PLAN intervention) |
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Arm II (Best practice) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (PLAN intervention), Arm II (Best practice) |
Primary outcome
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).
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.
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.
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.
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.
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,
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan J Shen, PhD principal investigator
Fred Hutch/University of Washington Cancer Consortium
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication Intervention, Best Practice and Questionnaire Administration in people with Locally Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, run by Fred Hutchinson Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (Number/Proportion of Participants Who Completed the Intervention) (time frame: Five weeks post-randomization (for intervention arm only)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.