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

NCT ID: NCT05629065

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-28

Study Completion Date

2028-06-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer Gastrointestinal Cancer Gynecologic Cancer Thoracic Cancer Genitourinary Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

4 arm randomized clinical trial
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Clinician Nudge Email

Intervention Type OTHER

-Clinician "nudge" email encouraging discussion to initiate discussion on SIC at next visit

Patient Nudge Letter and Share questionaire

Intervention Type OTHER

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.

Neither the patient nor clinician receive a nudge

Standard Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Patient receives a nudge but not the clinician

-Patient nudge consists of a letter and SHARE questionnaire

Group Type EXPERIMENTAL

Patient Nudge Letter and Share questionaire

Intervention Type OTHER

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.

Clinician receives a nudge but not the patient

-Clinician "nudge" email encouraging discussion to initiate discussion on SIC

Group Type EXPERIMENTAL

Clinician Nudge Email

Intervention Type OTHER

-Clinician "nudge" email encouraging discussion to initiate discussion on SIC at next visit

Interventions

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Clinician Nudge Email

-Clinician "nudge" email encouraging discussion to initiate discussion on SIC at next visit

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Christopher Manz, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Manz, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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22-501

Identifier Type: -

Identifier Source: org_study_id

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