Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC) ((PATH-SIC))

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Gynecologic Cancer; Thoracic Cancer; Gastrointestinal Cancer; Genitourinary Cancer
• Intervention / Treatment: Other: Clinician Nudge Email; Other: Patient Nudge Letter and Share questionaire

Detailed Description

The objective of this study is to implement an intervention in a pragmatic randomized controlled trial that uses cancer treatment pathways data to identify patients appropriate for serious illness conversations (SICs) and applies "nudges" to patients and their oncology clinicians to increase SICs and improve end of life (EOL) outcomes.

Identified participants and clinicians will be randomized into 1 or 4 groups.

• Nudge to patient and clinician
• Nudge to patient only
• Nudge to clinician only
• No nudge.

The expected enrollment is approximately 800 participants.

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who are aged 18 years or older, reach one of the poor prognosis nodes identified and have an upcoming appointment at one of the following Dana Farber Cancer Institute oncology clinics (including Longwood and Chestnut Hill locations)
• Breast Oncology Clinic
• Gastrointestinal Oncology Clinic
• Genitourinary Oncology Clinic
• Gynecologic Oncology Clinic
• Thoracic Oncology 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Both patient and clinician receive a nudge; Patient nudge consists of a letter and SHARE questionnaire; Clinician "nudge" email encouraging discussion to initiate discussion on SIC	Other: Clinician Nudge Email; -Clinician "nudge" email encouraging discussion to initiate discussion on SIC at next visit; Other: Patient Nudge Letter and Share questionaire; Involves patient nudge consists of a letter and SHARE questionnaire - patient nudge is a letter and a SHARE questionnaire encourages the participant to complete the SHARE questionnaire, which asks questions about the participants goals and preferences around cancer care, and discuss the questionnaire with their oncology clinician at the next visit.
No Intervention: Neither the patient nor clinician receive a nudge; Standard Care
Experimental: Patient receives a nudge but not the clinician; -Patient nudge consists of a letter and SHARE questionnaire	Other: Patient Nudge Letter and Share questionaire; Involves patient nudge consists of a letter and SHARE questionnaire - patient nudge is a letter and a SHARE questionnaire encourages the participant to complete the SHARE questionnaire, which asks questions about the participants goals and preferences around cancer care, and discuss the questionnaire with their oncology clinician at the next visit.
Experimental: Clinician receives a nudge but not the patient; -Clinician "nudge" email encouraging discussion to initiate discussion on SIC	Other: Clinician Nudge Email; -Clinician "nudge" email encouraging discussion to initiate discussion on SIC at next visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with an SIC at 60 days for arm 1 (patient +clinician nudge) vs arm 2 (no nudge).	The numerator includes patients with any SIC documentation extracted from the Advanced Care Planning module between the date of the poor prognosis node and 60 days. The denominator is all patients randomized to the applicable study arm.	up to 60 days after reaching the poor prognosis node

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with an SIC at 60 days, comparison of all 4 study arms	Same as the primary outcome	up to 60 days after reaching the poor prognosis node
Time from SIC to death among decedents	Time from SIC to death among decedents	randomization up to 1 year
Receipt of chemotherapy in last 14 days of life	Whether or not the patient received chemotherapy in the last 14 days of life, among decedents	randomization up to 1 year
ED visits in the last 30 days of life	Number of ED visits in the last 30 days of life, among decedents	randomization up to 1 year
Hospitalization in last 30 days of life	Hospitalization in the last 30 days of life, among decedents	randomization up to 1 year
Median length of hospitalization	Median length of last hospitalization, in days among decedents	randomization up to 1 year
ICU utilization in last 30 days of life	ICU hospitalization in the last 30 days of life, among decedents	randomization up to 1 year
Death in an acute care facility	Presence or absence of death in an acute care facility like a hospital or emergency room	randomization up to 1 year
Death in the ICU	Whether or not death occurred in an ICU	randomization up to 1 year
Hospice enrollment at death	Whether or not the patient was enrolled in hospice on the day of death	randomization up to 1 year
Enrolled < 4 days in hospice at death	Whether or not the patient was enrolled in hospice for less than 4 days on the day of death	randomization up to 1 year
Patient preferences	Patient responses on SHARE questionnaire	Up to 60 days after randomization

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Christopher Manz, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2022
• Primary Completion (Actual): September 30, 2024
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Breast Cancer; Gastrointestinal Cancer; Genitourinary Cancer; Gynecologic Cancer; Thoracic Cancer; Serious Illness Communication
• Additional Relevant MeSH Terms: Urogenital Diseases; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Gastrointestinal Neoplasms; Urogenital Neoplasms
• Other Study ID Numbers: 22-501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No