Communication Intervention for Cancer Planning

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Megan J Shen, PhD.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Weill Medical College of Cornell University

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Planning for Your Advance Care Needs (PLAN) for cancer patients?

Research shows that advance care planning, which involves discussing and recording patient preferences for future care, can improve communication between patients and doctors, especially at the end of life. Educating people about advance care planning has been effective in encouraging them to start important conversations and make necessary preparations. ^{1 2 3 4 5}

Is the Communication Intervention for Cancer Planning safe for humans?

The research articles reviewed do not provide specific safety data for the Communication Intervention for Cancer Planning or its related programs. ^{6 7 8 9 10}

How is the treatment 'Planning for Your Advance Care Needs' different from other treatments for cancer planning?

This treatment is unique because it focuses on improving communication skills for advance care planning, helping patients and their families have important conversations about future healthcare decisions, rather than focusing on medical or pharmaceutical interventions. ^{5 8 11 12 13}

Research Team

Megan J Shen, PhD.

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Planning for Your Advance Care Needs (PLAN) (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Robert Min

Weill Medical College of Cornell University

Chief Executive Officer since 2024

MD, MBA

Dr. Adam R. Stracher

Weill Medical College of Cornell University

Chief Medical Officer since 2024

MD

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

Dr. W. Thomas Purcell

Fred Hutchinson Cancer Center

Chief Medical Officer since 2022

MD from Emory University School of Medicine, MBA from University of Chicago

Dr. Thomas J. Lynch Jr.

Fred Hutchinson Cancer Center

Chief Executive Officer since 2020

MD from Yale School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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 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]

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]

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]

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 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 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]

References

1. United States 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The effects of advance care planning on end-of-life care: a systematic review. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Toward improved goals-of-care documentation in advanced cancer: report on the development of a quality improvement initiative. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Resident approaches to advance care planning on the day of hospital admission. [2006]

5. England pubmed.ncbi.nlm.nih.gov

Impact of a community health conversation upon advance care planning attitudes and preparation intentions. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

The PREPARE for Your Care program increases advance care planning engagement among diverse older adults with cancer. [2022]

7. Switzerland 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Development of a Community Advance Care Planning Guides Program and the RELATE Model of Communication. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Definition and recommendations for advance care planning: an international consensus supported by the European Association for Palliative Care. [2018]

10. United States 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. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Impacts of an advance care planning intervention on close relationships. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Development and feasibility of a communication training to assist caregivers with advanced care planning. [2023]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Advance Care Planning and Goals of Care Discussion: Barriers from the Perspective of Medical Residents. [2023]