Communication Strategies for End-of-Life Cancer Care

((PATH-SIC) Trial)

Overseen By Christopher Manz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Prior SIC, Previous randomization

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve conversations between cancer patients and their doctors about healthcare goals and preferences near the end of life. It tests different methods to encourage these discussions, such as sending reminder emails to doctors (Clinician Nudge Email) or letters and questionnaires to patients (Patient Nudge Letter and Share questionnaire). Participants include cancer patients at certain Dana Farber Cancer Institute clinics who have recently received a poor prognosis. Those without a recent serious illness conversation recorded in their medical records might be a good fit for this trial. As an unphased study, this trial offers a unique opportunity to enhance patient-doctor communication at a critical time.

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 these communication strategies are safe for end-of-life cancer care?

Research has shown that reminders, such as emails and letters, can facilitate important conversations about end-of-life care between doctors and patients. For doctors, these reminders encourage the initiation of these discussions. Studies indicate that these reminders enhance communication without causing harm.

For patients, a reminder might include a letter and a SHARE questionnaire, which helps them consider their preferences and communicate them to their doctors. Research has shown this method is safe and improves discussions about care choices.

Overall, both types of reminders are well-received and have not been linked to any serious issues. They aim to help doctors and patients talk more openly about important healthcare decisions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative communication strategies in end-of-life cancer care. Unlike traditional treatment options that focus solely on medical intervention, this trial uses "nudges" to enhance discussions between patients and clinicians about serious illness communication (SIC). The unique approach includes a nudge email for clinicians and a nudge letter with a SHARE questionnaire for patients, aiming to prompt meaningful conversations about care preferences. This method could significantly improve patients' quality of life by ensuring their wishes are understood and respected, offering a more personalized and empathetic end-of-life care experience.

What evidence suggests that this trial's communication strategies could be effective for end-of-life cancer care?

This trial will evaluate different communication strategies for end-of-life cancer care. Studies have shown that gentle reminders, or "nudges," can improve communication in cancer care. In this trial, some participants will receive a nudge letter and a SHARE questionnaire to help them consider and communicate their healthcare wishes. Clinicians in certain trial arms will receive electronic nudges, such as emails, to increase the number of important end-of-life conversations with patients. Research has found that these nudges can make these discussions occur four times more often, leading to better care. Together, these nudges for both doctors and patients have been linked to a small increase in recording these important conversations. This approach aims to ensure that end-of-life care aligns with patients' wishes and preferences. ^{5 6 7 8 9}

Who Is on the Research Team?

Christopher Manz, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults with certain types of cancer (urogenital, breast, gastrointestinal, gynecologic, genitourinary, or lung) who have a poor prognosis and an upcoming appointment at specific Dana Farber Cancer Institute oncology clinics. Those already having serious illness conversations documented or previously enrolled in this trial are excluded.

Inclusion Criteria

I am 18 or older, have a poor prognosis, and have an appointment at a specified Dana Farber clinic.

Exclusion Criteria

Patients with an SIC documented in the Advance Care Planning module of the electronic health record in the 6 months prior to reaching a poor prognosis node

Patients who have previously been randomized in this trial (e.g., the patient is encountering a poor-prognosis node for the second time during the trial period)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants and clinicians receive nudges to increase serious illness conversations (SICs)

8 weeks

Multiple interactions (virtual)

Follow-up

Participants are monitored for the occurrence of serious illness conversations and end-of-life outcomes

up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Clinician Nudge Email
• Patient Nudge Letter and Share questionaire

Trial Overview The PATH-SIC study tests whether sending nudge emails to clinicians and letters plus questionnaires to patients can increase meaningful discussions about healthcare goals and end-of-life care preferences between cancer patients and their doctors.

How Is the Trial Designed?

Group I: Patient receives a nudge but not the clinician Experimental Treatment 1 Intervention

-Patient nudge consists of a letter and SHARE questionnaire

Group II: Clinician receives a nudge but not the patient Experimental Treatment 1 Intervention

-Clinician "nudge" email encouraging discussion to initiate discussion on SIC

Group III: Both patient and clinician receive a nudge Experimental Treatment 2 Interventions

* Patient nudge consists of a letter and SHARE questionnaire * Clinician "nudge" email encouraging discussion to initiate discussion on SIC

Group IV: Neither the patient nor clinician receive a nudge Active Control 1 Intervention

Standard Care

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

A qualitative study involving 25 oncology clinicians revealed that algorithm-based nudges effectively promote early serious illness conversations (SICs), which are crucial for improving patient mood and end-of-life care quality.

Clinicians noted that while these nudges helped with documentation and peer comparisons, challenges such as cancer-specific differences and the nature of communication methods need to be addressed to enhance the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncologist Perceptions of Algorithm-Based Nudges to Prompt Early Serious Illness Communication: A Qualitative Study. Parikh, RB., Manz, CR., Nelson, MN., et al.[2023]

This study will evaluate the effectiveness of both clinician- and patient-directed nudges to increase the completion of serious illness conversations (SICs) among high-risk cancer patients, involving 166 clinicians and approximately 5500 patients.

The primary outcome will be the time to SIC documentation, with secondary outcomes including palliative care referrals and the use of aggressive end-of-life care, aiming to improve patient outcomes and promote health equity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral economic implementation strategies to improve serious illness communication between clinicians and high-risk patients with cancer: protocol for a cluster randomized pragmatic trial. Takvorian, SU., Bekelman, J., Beidas, RS., et al.[2022]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2800545

Long-term Effect of Machine Learning–Triggered ... These results suggest that machine learning and behavioral nudges can lead to long-lasting improvements in cancer care delivery. Trial ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12220458/

Using nudges with electronic health records systems to ... Overall, findings suggest that EHR-integrated nudge strategies may improve documentation and communication practices related to ACP in patients with serious ...

3. bmcpalliatcare.biomedcentral.com bmcpalliatcare.biomedcentral.com/articles/10.1186/s12904-025-01820-4

Using nudges with electronic health records systems to ... Nudges with electronic health records (EHR) systems become a new way to encourage healthcare professionals to perform advance care planning (ACP).

4. pennmedicine.org pennmedicine.org/News/machine-learning-improves-end-of-life-care-for-cancer-patients

Algorithm-based reminders improve end-of-life care Electronic nudges delivered to health care clinicians based on a machine learning algorithm quadrupled rates of conversations with patients ...

5. academic.oup.com academic.oup.com/ageing/article/54/10/afaf280/8276056

cost-consequence analysis of a nudge intervention to improve ... A cost-consequence analysis of a nudge intervention to improve hospital care of older people at the end of life: results from a stepped-wedge ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK599854/

Artificial Intelligence Decision Support Tools for End-of-Life ... An AI-based behavioural intervention, referred to as a “nudge,” uses alerts and/or reminders to prompt clinicians to initiate end-of-life conversations with ...

7. statnews.com statnews.com/2020/11/16/nudge-helps-doctors-discuss-end-of-life-issues-dying-cancer-patients/

A nudge helps doctors discuss end-of-life issues with dying ... A nudge based on artificial intelligence helps cancer doctors start conversations with their dying patients about their end-of-life wishes.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838682

Critical Care Physicians' Perspectives on Nudging in ... This qualitative study explores critical care physicians' perspectives on nudging to guide patients in clinical decision-making.

9. ldi.upenn.edu ldi.upenn.edu/our-work/research-updates/ai-intervention-reduced-end-of-life-spending-for-patients-with-cancer/

AI Intervention Reduced End-of-Life Spending for Patients ... A machine-learning algorithm combined with behavioral nudges is associated with reduced health care spending in cancer care.