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

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

NCT ID: NCT05629065

Condition: Breast Cancer
Gastrointestinal Cancer
Gynecologic Cancer
Thoracic Cancer
Genitourinary Cancer

Conditions: Official terms:
Gastrointestinal Neoplasms
Urogenital Neoplasms

Conditions: Keywords:
Breast Cancer
Gastrointestinal Cancer
Gynecologic Cancer
Thoracic Cancer
Genitourinary Cancer
Serious Illness Communication

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Factorial Assignment

Intervention model description: 4 arm randomized clinical trial

Primary purpose: Other

Masking: Single (Investigator)

Intervention:

Intervention type: Other
Intervention name: Clinician Nudge Email
Description: -Clinician "nudge" email encouraging discussion to initiate discussion on SIC at next visit
Arm group label: Both patient and clinician receive a nudge
Arm group label: Clinician receives a nudge but not the patient

Intervention type: Other
Intervention name: Patient Nudge Letter and Share questionaire
Description: 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.
Arm group label: Both patient and clinician receive a nudge
Arm group label: Patient receives a nudge but not the clinician

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.

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.

Criteria for eligibility:
Criteria:
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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Dana Farber Cancer Institute

Address:
City: Boston
Zip: 02115
Country: United States

Start date: November 28, 2022

Completion date: July 31, 2025

Lead sponsor:
Agency: Dana-Farber Cancer Institute
Agency class: Other

Source: Dana-Farber Cancer Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05629065