Communication Intervention for Cancer Planning

No longer recruiting at 3 trial locations

Overseen By Megan J Shen, PhD.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Non-fluent, Cognitive impairment, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Latino patients with cancer better understand and engage in advanced care planning. It focuses on a program called Planning for Your Advance Care Needs (PLAN), which includes three coaching sessions to guide patients in discussing their care preferences if they become unable to communicate in the future. The trial compares this program to usual care to determine which is more effective. Individuals who identify as Latino and have advanced cancer that has progressed after initial treatment may be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance care planning for Latino patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the PLAN intervention is safe for cancer patients?

Research has shown that programs like Planning for Your Advance Care Needs (PLAN) are generally well-received. These programs help patients consider and discuss their future healthcare wishes. Studies have found that they can lead to more patients receiving care at home rather than in hospitals.

The PLAN program includes coaching sessions to guide these conversations. Reports have not indicated any negative effects from these programs, suggesting they are safe for participants. The main goal is to improve communication about future care plans, which poses no risk of physical harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Communication Intervention for Cancer Planning trial because it explores a new way to help patients with their future care decisions. Unlike standard practices where patients receive typical care, the PLAN intervention offers personalized coaching sessions. This approach involves three sessions with a health coach, each lasting 45–60 minutes, aimed at empowering patients to actively plan their advance care needs. By focusing on personalized communication and planning, the trial hopes to improve patient satisfaction and decision-making in cancer care.

What evidence suggests that the PLAN intervention is effective for enhancing cancer patients' advance care planning?

Research has shown that the Planning for Your Advance Care Needs (PLAN) program helps Latino patients with advanced cancer plan their future medical care. This trial compares two approaches: participants in Arm I receive the PLAN intervention, which includes coaching sessions to facilitate discussions about end-of-life care needs. It also employs tools like patient video decision aids and focuses on improving communication with doctors to support advance care planning. Participants in Arm II receive usual care as a best practice comparator. Studies have found that planning ahead significantly increases the number of people who complete advance directives, which are legal documents outlining a person's medical treatment wishes. Overall, these methods aim to empower patients to make informed decisions about their future healthcare. ^{1 2 3 6 7}

Who Is on the Research Team?

Megan J Shen, PhD.

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for Latino adults with advanced or metastatic cancer who have had at least one round of chemotherapy. They must be able to give informed consent and speak English or Spanish fluently. It's not suitable for those severely cognitively impaired, too ill to interview, currently in hospice care, under 18, or deemed unsuitable by their oncologist.

Inclusion Criteria

You are of Latino ethnicity.

My cancer is advanced or has spread, and it got worse after my first chemotherapy.

Ability to provide informed consent

Exclusion Criteria

Patients deemed inappropriate for the study by their treating oncologist

I am too sick or weak to complete interviews.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in Arm I receive the PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach. Arm II participants receive usual care.

1 week

3 visits (in-person or virtual)

Follow-up

Participants are monitored for changes in engagement, self-efficacy, completion of advance directives, feasibility, acceptability, knowledge, and readiness/motivation in advance care planning.

3 months

2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Planning for Your Advance Care Needs (PLAN)

Trial Overview The trial examines the 'PLAN' intervention—a method aimed at improving Latino cancer patients' understanding and participation in advance care planning discussions with family and doctors. It involves a communication strategy, adherence to best practices, and questionnaire feedback.

How Is the Trial Designed?

Group I: Arm I (PLAN intervention) Experimental Treatment 2 Interventions

Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach.

Group II: Arm II (Best practice) Active Control 2 Interventions

Patients receive usual care.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A study involving 29 medical residents in Brazil identified key barriers to discussing goals of care with oncology patients, including patients' and families' difficulties in understanding their diagnosis and prognosis, as well as a strong desire for full active treatment.

External factors such as lack of training and time constraints for physicians were also significant barriers, highlighting the need for targeted interventions to improve advance care planning discussions in clinical oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance Care Planning and Goals of Care Discussion: Barriers from the Perspective of Medical Residents. Dias, LM., Frutig, MA., Bezerra, MR., et al.[2023]

The ACTION advance care planning (ACP) intervention fosters open communication between patients with advanced cancer and their Personal Representatives (PRs), allowing them to share concerns and expectations about the illness, which can strengthen their relationships.

While the ACP process enhances mutual understanding and connectedness, it can also bring up difficult topics that require skilled facilitation to navigate effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impacts of an advance care planning intervention on close relationships. Bulli, F., Toccafondi, A., Kars, MC., et al.[2023]

A 1-hour educational presentation on advance care planning significantly increased community members' intentions to discuss and prepare for end-of-life decisions, showing interest across all age groups.

The study highlighted that after the intervention, participants were more likely to engage in conversations about advance care planning with loved ones and healthcare providers, indicating the effectiveness of education in promoting these important discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a community health conversation upon advance care planning attitudes and preparation intentions. Carney, MT., Williams, M., Zhang, M., et al.[2021]

Advance care planning (ACP) in cancer care is underutilized, with inconsistent definitions and rarely supported benefits, highlighting the need for clearer guidelines and evidence-based practices.

Interventions to improve ACP have primarily focused on patients, but more barriers exist at the healthcare provider level, suggesting that targeting providers is crucial for increasing ACP uptake in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Why is advance care planning underused in oncology settings? A systematic overview of reviews to identify the benefits, barriers, enablers, and interventions to improve uptake. Guccione, L., Fullerton, S., Gough, K., et al.[2023]

The ACTION trial successfully developed a multinational advance directive called the 'My Preferences form' for patients with advanced cancer, involving input from 28 consortium members and clinicians across six European countries.

The process required extensive modifications to ensure cultural and legal appropriateness, resulting in a comprehensive communication tool aimed at supporting end-of-life decision-making for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an advance directive 'communication tool' relevant for patients with advanced cancer in six European countries: Experiences from the ACTION trial. Arnfeldt, CM., Groenvold, M., Johnsen, AT., et al.[2022]

In a study involving 59 patients with metastatic urological cancers, 85% successfully completed an advance directive or POLST form, indicating a high rate of advance care planning when integrated palliative care is offered immediately after urology appointments.

The majority of patients (98%) expressed a preference to withhold aggressive end-of-life interventions, such as cardiopulmonary resuscitation and artificial nutrition, highlighting a general aversion to aggressive treatments in terminal illness situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance Care Planning and Patient Preferences in a Feasibility Pilot Study to Improve End-of-Life Communication among Men with Metastatic Urological Malignancies. Pannell, SC., Laviana, AA., Huen, KHY., et al.[2023]

Advance care planning can significantly improve end-of-life care by decreasing the use of life-sustaining treatments and increasing the use of hospice and palliative care, based on a systematic review of 113 studies published between 2000 and 2012.

Complex interventions in advance care planning are more effective in ensuring that patients' end-of-life wishes are met compared to simpler methods like written directives, highlighting the need for more experimental studies in diverse settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of advance care planning on end-of-life care: a systematic review. Brinkman-Stoppelenburg, A., Rietjens, JA., van der Heide, A.[2022]

In a study of 456 patients with terminal cancer, only 6% had documented care goals in case of acute deterioration, highlighting a significant gap in advance care planning.

A quality improvement initiative was launched to enhance documentation and referral rates to palliative care, aiming to ensure better patient support and care planning in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward improved goals-of-care documentation in advanced cancer: report on the development of a quality improvement initiative. Harle, I., Karim, S., Raskin, W., et al.[2022]

A survey of 292 internal medicine residents revealed that while 70.5% discussed CPR preferences with patients on admission, only 33.7% established a health care proxy and 32.0% discussed end-of-life goals, indicating a gap in comprehensive advance care planning.

Residents who received feedback on advance care planning conversations were more likely to engage in discussions about health care proxies and end-of-life goals, suggesting that targeted training could enhance communication in this critical area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resident approaches to advance care planning on the day of hospital admission. Smith, AK., Ries, AP., Zhang, B., et al.[2006]

The ACP Community Guides Program successfully trained 22 laypersons in communication skills for advance care planning (ACP) conversations, achieving a 100% retention rate through all training sessions.

Trained ACP Guides effectively utilized the RELATE model of communication during conversations, indicating that laypersons can facilitate meaningful peer-to-peer discussions about advance care planning in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Community Advance Care Planning Guides Program and the RELATE Model of Communication. Candrian, C., Lasker Hertz, S., Matlock, D., et al.[2022]

The PREPARE for Your Care website, combined with an easy-to-read advance directive, significantly increased advance care planning (ACP) documentation among older adults with cancer (62% vs 43%) and those without cancer (38% vs 28%) compared to using an advance directive alone.

Engagement in ACP through the PREPARE program did not lead to increased levels of depression or anxiety, indicating that it is a safe and effective tool for improving ACP among diverse older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The PREPARE for Your Care program increases advance care planning engagement among diverse older adults with cancer. Nouri, SS., Barnes, DE., Shi, Y., et al.[2022]

A communication training program for caregivers of patients with malignant brain tumors was developed and found to be feasible and acceptable, with 100% of participants feeling confident in using the skills learned to facilitate advanced care planning (ACP) discussions.

Post-training evaluations showed that 40% of caregivers felt confident discussing ACP with loved ones and 67% felt confident with healthcare professionals, indicating the training's potential to enhance caregivers' communication skills and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and feasibility of a communication training to assist caregivers with advanced care planning. Applebaum, AJ., Gebert, R., Behrens, M., et al.[2023]

A formal Delphi consensus involving 109 experts defined advance care planning (ACP) as a process that helps individuals articulate their medical treatment goals and preferences, discuss them with family and healthcare providers, and document these preferences.

The study provided 41 recommendations for implementing ACP, emphasizing the need to tailor the process to individual readiness and health conditions, and suggesting the use of trained non-physician facilitators to enhance the ACP experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definition and recommendations for advance care planning: an international consensus supported by the European Association for Palliative Care. Rietjens, JAC., Sudore, RL., Connolly, M., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10377387/

Planning for Your Advance Care Needs (PLAN) The goal of this study was to develop an intervention designed to help improve engagement in advance care planning among Latino patients with advanced cancer.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12405694/

Evaluating outcomes of advance care planning interventions ... Advance care planning enables individuals to define goals and preferences for future medical care. Despite advances in research and the ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833774

An Intervention to Increase Advance Care Planning Among ... The results of this study suggest that implementing patient video decision aids along with bolstering clinician communication skills can improve clinical ACP ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020748925001051

Effects of advance care planning for patients with ... The results of the meta-analysis implied that advance care planning significantly improved the completion of advance directives (OR = 7.93, 95 % CI: 2.76–22.77, ...

5. researchgate.net researchgate.net/publication/372381023_Planning_for_Your_Advance_Care_Needs_PLAN_A_Communication_Intervention_to_Improve_Advance_Care_Planning_among_Latino_Patients_with_Advanced_Cancer

(PDF) Planning for Your Advance Care Needs (PLAN) PLAN uses this framework to coach patients on how to plan for and communicate their end-of-life care needs through ACP. In the present study, ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1470211825000570

CME: Palliative Medicine Advance care planning Advance Care Planning (ACP) is the process of thinking about, discussing and making plans for future health and social care.

7. journals.plos.org journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003422

Advance care planning in patients with advanced cancer Advance care planning (ACP) supports individuals to define, discuss, and record goals and preferences for future medical treatment and care.