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

Breast Cancer Clinical Trial

— (PATH-SIC)  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05629065
• Other study ID #: 22-501
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 28, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 800
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Genitourinary Cancer
• Gynecologic Cancer
• Thoracic Cancer
• Urogenital Neoplasms

Intervention

Other:
• Clinician Nudge Email
-Clinician "nudge" email encouraging discussion to initiate discussion on SIC at next visit
• 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.

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time from SIC to death among decedents	Time from SIC to death among decedents	randomization up to 1 year
Secondary	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
Secondary	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
Secondary	Hospitalization in last 30 days of life	Hospitalization in the last 30 days of life, among decedents	randomization up to 1 year
Secondary	Median length of hospitalization	Median length of last hospitalization, in days among decedents	randomization up to 1 year
Secondary	ICU utilization in last 30 days of life	ICU hospitalization in the last 30 days of life, among decedents	randomization up to 1 year
Secondary	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
Secondary	Death in the ICU	Whether or not death occurred in an ICU	randomization up to 1 year
Secondary	Hospice enrollment at death	Whether or not the patient was enrolled in hospice on the day of death	randomization up to 1 year
Secondary	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
Secondary	Patient preferences	Patient responses on SHARE questionnaire	Up to 60 days after randomization