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

800 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to increase serious illness conversations (SICs) about patients goals and preferences regarding their healthcare between patients with cancer and their oncology clinicians and improved care provided near the end of life.

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 Communication Strategies for End-of-Life Cancer Care?

Research shows that using nudges, like letters and emails, can help increase important conversations about end-of-life care between patients and doctors. These strategies have been effective in getting more patients to complete advance directives, which are documents that outline their care preferences. ^{1 2 3 4 5}

Is the Communication Strategies for End-of-Life Cancer Care treatment safe for humans?

The research on communication strategies like Clinician Nudge Email, Patient Nudge Letter, and Share questionnaire focuses on improving conversations about end-of-life care, and there are no safety concerns reported in the studies. These strategies are generally safe as they involve behavioral nudges and communication improvements rather than medical interventions. ^{1 2 3 5 6}

How does this treatment differ from other end-of-life cancer care treatments?

This treatment is unique because it uses behavioral nudges to encourage both patients and clinicians to have important conversations about end-of-life care preferences, which are often not documented. By focusing on communication strategies, it aims to improve patient outcomes by aligning care with patients' values and goals. ^{1 2 4 5 6}

Research Team

Christopher Manz, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England 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. [2022]

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

Remote Patient-Reported Outcomes and Activity Monitoring to Improve Patient-Clinician Communication Regarding Symptoms and Functional Status: A Randomized Controlled Trial. [2023]

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

The Role of Information and Nudges on Advance Directives and End-of-Life Planning: Evidence From a Randomized Trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Patient and clinician nudges to improve symptom management in advanced cancer using patient-generated health data: study protocol for the PROStep randomised controlled trial. [2022]

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

Oncologist Perceptions of Algorithm-Based Nudges to Prompt Early Serious Illness Communication: A Qualitative Study. [2023]

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

Electronic prompt to improve outpatient code status documentation for patients with advanced lung cancer. [2022]