Back to resultsPathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC) ((PATH-SIC))
Primary Purpose
Breast Cancer, Gastrointestinal Cancer, Gynecologic Cancer
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinician Nudge Email
Patient Nudge Letter and Share questionaire
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer focused on measuring Breast Cancer, Gastrointestinal Cancer, Gynecologic Cancer, Thoracic Cancer, Genitourinary Cancer, Serious Illness Communication
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)
Sites / Locations
- Dana Farber Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
Experimental
Arm Label
Both patient and clinician receive a nudge
Neither the patient nor clinician receive a nudge
Patient receives a nudge but not the clinician
Clinician receives a nudge but not the patient
Arm Description
Patient nudge consists of a letter and SHARE questionnaire Clinician "nudge" email encouraging discussion to initiate discussion on SIC
Standard Care
-Patient nudge consists of a letter and SHARE questionnaire
-Clinician "nudge" email encouraging discussion to initiate discussion on SIC
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Proportion of patients with an SIC at 60 days, comparison of all 4 study arms
Same as the primary outcome
Time from SIC to death among decedents
Time from SIC to death among decedents
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
ED visits in the last 30 days of life
Number of ED visits in the last 30 days of life, among decedents
Hospitalization in last 30 days of life
Hospitalization in the last 30 days of life, among decedents
Median length of hospitalization
Median length of last hospitalization, in days among decedents
ICU utilization in last 30 days of life
ICU hospitalization in the last 30 days of life, among decedents
Death in an acute care facility
Presence or absence of death in an acute care facility like a hospital or emergency room
Death in the ICU
Whether or not death occurred in an ICU
Hospice enrollment at death
Whether or not the patient was enrolled in hospice on the day of death
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
Patient preferences
Patient responses on SHARE questionnaire
Full Information
NCT ID
NCT05629065
First Posted
November 17, 2022
Last Updated
December 19, 2022
Sponsor
Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT05629065
Brief Title
Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC)
Acronym
(PATH-SIC)
Official Title
Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 28, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Gastrointestinal Cancer, Gynecologic Cancer, Thoracic Cancer, Genitourinary Cancer
Keywords
Breast Cancer, Gastrointestinal Cancer, Gynecologic Cancer, Thoracic Cancer, Genitourinary Cancer, Serious Illness Communication
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
4 arm randomized clinical trial
Masking
Investigator
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Both patient and clinician receive a nudge
Arm Type
Experimental
Arm Description
Patient nudge consists of a letter and SHARE questionnaire
Clinician "nudge" email encouraging discussion to initiate discussion on SIC
Arm Title
Neither the patient nor clinician receive a nudge
Arm Type
No Intervention
Arm Description
Standard Care
Arm Title
Patient receives a nudge but not the clinician
Arm Type
Experimental
Arm Description
-Patient nudge consists of a letter and SHARE questionnaire
Arm Title
Clinician receives a nudge but not the patient
Arm Type
Experimental
Arm Description
-Clinician "nudge" email encouraging discussion to initiate discussion on SIC
Intervention Type
Other
Intervention Name(s)
Clinician Nudge Email
Intervention Description
-Clinician "nudge" email encouraging discussion to initiate discussion on SIC at next visit
Intervention Type
Other
Intervention Name(s)
Patient Nudge Letter and Share questionaire
Intervention 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.
Primary Outcome Measure Information:
Title
Proportion of patients with an SIC at 60 days for arm 1 (patient +clinician nudge) vs arm 2 (no nudge).
Description
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.
Time Frame
up to 60 days after reaching the poor prognosis node
Secondary Outcome Measure Information:
Title
Proportion of patients with an SIC at 60 days, comparison of all 4 study arms
Description
Same as the primary outcome
Time Frame
up to 60 days after reaching the poor prognosis node
Title
Time from SIC to death among decedents
Description
Time from SIC to death among decedents
Time Frame
randomization up to 1 year
Title
Receipt of chemotherapy in last 14 days of life
Description
Whether or not the patient received chemotherapy in the last 14 days of life, among decedents
Time Frame
randomization up to 1 year
Title
ED visits in the last 30 days of life
Description
Number of ED visits in the last 30 days of life, among decedents
Time Frame
randomization up to 1 year
Title
Hospitalization in last 30 days of life
Description
Hospitalization in the last 30 days of life, among decedents
Time Frame
randomization up to 1 year
Title
Median length of hospitalization
Description
Median length of last hospitalization, in days among decedents
Time Frame
randomization up to 1 year
Title
ICU utilization in last 30 days of life
Description
ICU hospitalization in the last 30 days of life, among decedents
Time Frame
randomization up to 1 year
Title
Death in an acute care facility
Description
Presence or absence of death in an acute care facility like a hospital or emergency room
Time Frame
randomization up to 1 year
Title
Death in the ICU
Description
Whether or not death occurred in an ICU
Time Frame
randomization up to 1 year
Title
Hospice enrollment at death
Description
Whether or not the patient was enrolled in hospice on the day of death
Time Frame
randomization up to 1 year
Title
Enrolled < 4 days in hospice at death
Description
Whether or not the patient was enrolled in hospice for less than 4 days on the day of death
Time Frame
randomization up to 1 year
Title
Patient preferences
Description
Patient responses on SHARE questionnaire
Time Frame
Up to 60 days after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Manz, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC)
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