Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC)
(PATH-SIC)
1 other identifier
interventional
800
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Nov 2022
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2022
CompletedStudy Start
First participant enrolled
November 28, 2022
CompletedFirst Posted
Study publicly available on registry
November 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
ExpectedAugust 28, 2025
August 1, 2025
1.8 years
November 17, 2022
August 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
Proportion of patients with an SIC at 60 days, comparison of all 4 study arms
up to 60 days after reaching the poor prognosis node
Time from SIC to death among decedents
randomization up to 1 year
Receipt of chemotherapy in last 14 days of life
randomization up to 1 year
ED visits in the last 30 days of life
randomization up to 1 year
Hospitalization in last 30 days of life
randomization up to 1 year
- +7 more secondary outcomes
Study Arms (4)
Both patient and clinician receive a nudge
EXPERIMENTAL* Patient nudge consists of a letter and SHARE questionnaire * Clinician "nudge" email encouraging discussion to initiate discussion on SIC
Neither the patient nor clinician receive a nudge
NO INTERVENTIONStandard Care
Patient receives a nudge but not the clinician
EXPERIMENTAL-Patient nudge consists of a letter and SHARE questionnaire
Clinician receives a nudge but not the patient
EXPERIMENTAL-Clinician "nudge" email encouraging discussion to initiate discussion on SIC
Interventions
-Clinician "nudge" email encouraging discussion to initiate discussion on SIC at next visit
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Manz, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 17, 2022
First Posted
November 29, 2022
Study Start
November 28, 2022
Primary Completion
September 30, 2024
Study Completion (Estimated)
June 1, 2028
Last Updated
August 28, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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.